Journal of Hand Therapy 27 (2014) 85e95

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Current uses of botulinum toxin A as an adjunct to hand therapy interventions of hand conditions Loree K. Kalliainen MD, MA, FACS a, Virginia H. O’Brien OTD, OTR/L, CHT b, * a b

Mail Stop 11503B, 640 Jackson Street, St. Paul, MN 55101, USA University Orthopaedics Therapy Center, Fairview Hand Center, Minneapolis, MN 55454, USA

a r t i c l e i n f o

a b s t r a c t

Article history: Received 13 June 2013 Received in revised form 2 December 2013 Accepted 2 December 2013 Available online 10 December 2013

Study design: Literature review. Discussion: Botulinum toxin A, a neurotoxin causing temporary muscle paralysis at the neuromuscular junction, has been used to treat multiple acquired conditions of the hand and upper extremity. Initially approved for use in treating blepharospasm and strabismus in the 1980s, indications have expanded to include spasticity associated with cerebrovascular accidents, vasospastic disorders, focal dystonias, and pain conditions. This article reviews the current literature discussing the efficacy of botulinum toxin A in management of disorders of the hand and upper extremity relevant to hand therapists. Level of evidence: NA. Ó 2014 Hanley & Belfus, an imprint of Elsevier Inc. All rights reserved.

Keywords: Vasospastic disorders Focal dystonia Pain conditions Spasticity Botulinum toxin A Botox Hand disorders Upper extremity disorders Hand therapy

Introduction Botulinum toxin A (BTxA) is a neurotoxin produced by the bacterium Clostridium botulinum. First purified in 1928,1 it was not used for human medical conditions until the 1980s when it was first injected to treat strabismus.2 BTxA causes muscle paralysis by blocking the release of acetylcholine at the neuromuscular junction. The effect is temporary, and over time, local nerve fibers sprout and form new functional connections with muscle fibers. The sprouts “prune” back over several months following the injection, and muscle function gradually normalizes.3 The indications for the use of BTxA as a treatment for hand conditions have been expanding over the past two decades.4 Some indications have not been widely adopted because of minimal perceived benefit such as in treating carpal tunnel syndrome and essential tremor,4 BTxA has been recognized to be of benefit in the treatment of persons with certain conditions including

This manuscript was not adapted from any presentation and no grant support was received related to this paper. * Corresponding author. Tel.: þ1 651 245 6664; fax: þ1 612 273 7880. E-mail addresses: [email protected], [email protected] (V.H. O’Brien).

stroke/spasticity, vasospastic disorders, focal dystonia, and pain conditions. The data supporting other indications are yet in their relative infancy, and true benefit has yet to be determined or widely accepted for conditions such as chronic regional pain syndrome [CRPS] and lateral epicondylitis. The purposes of this article are to review the literature associated with current indications for BtxA in the hand with a focus on conditions commonly cared for by hand therapists and to discuss directions for future research. Stroke/spasticity Spasticity occurs in approximately 20e40% of people who have had a stroke and generally develops by three months post-stroke.5e7 Spastic hypertonicity is related to co-contraction, muscle shortening, and loss of volitional control of the extremity and causes a variety of difficulties including problems with hygiene and selfcare, inability to perform activities of daily living and subsequent need for a caregiver to assist with them, discomfort, and social or cosmetic concerns related to the hypertonicity. In many studies of spasticity, the degree of hypertonicity has been evaluated using the Modified Ashworth Scale (MAS).8 While the MAS is a popular clinical scale of spasticity, its reliability has been brought into

0894-1130/$ e see front matter Ó 2014 Hanley & Belfus, an imprint of Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jht.2013.12.003

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Table 1 Ashworth and Modified Ashworth Scales Ashworth Scale

Score

Modified Ashworth Scale (numbers in parentheses are those for the MAS)

No increase in tone Slight increase in tone giving a “catch” when the limb was moved in flexion or extension (no measure)

0 1

More marked increase in tone but limb easily flexed/extended

2 (3)

Considerable increase in tone, passive movement difficult Limb rigid in flexion or extension

3 (4) 4 (5)

No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at end ROM Slight increase muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM More marked increase in muscle tone through most of the ROM, but the affected part(s) is easily moved Considerable increase in muscle tone, passive movement is difficult Affected part(s) rigid in flexion or extension

1þ (2)

ROM, range of motion; (#), transcription at times used for Modified Ashworth Scale. Reference: Biering-Sorensen et al (2006).12

question,9e12 and a newer scale has arisen, the Modified Modified Ashworth Scale (MMAS)13 (Tables 1 and 2) [It is not within the scope of this paper to delineate the differences between the spasticity scales, only to report significant findings. Therefore further references in this paper to any of the Ashworth scales will be noted as MAS for simplicity.]. In addition to physical concerns, total costs of care have been shown to be significantly greater in patients with spasticity compared to those without.14 BTxA has been used to decrease hypertonicity with demonstrated, albeit short-term, benefit to patients and their caregivers and to decrease cost of care.14e17 The injection of BtxA is generally performed with the assistance of electromyography. Doses have varied widely, from 7.5 u to 200 u BtxA/muscle depending on the muscle. Smaller finger and thumb flexors have generally been treated with smaller doses (20 u) while larger muscles such as the biceps have been treated with larger doses (75e200 u).18e22 Several authors have standardized the dose to 50 u BtxA/muscle injected.16,17,23e25 Childers18 attempted to show a doseeresponse relationship between the amount of BtxA and the specific muscle injected, but the study had the potentially significant limitation in that concomitant therapies, including orthotic intervention, which were not standardized. If patients were already undergoing therapy, they could continue, but the therapy protocol could not be changed after the BtxA injection. Other studies have shown that focused therapy associated with the BtxA injections has improved functional outcomes, making this a potentially significant variable.21,22,26,27 In addition, only patients with “very severe” wrist spasticity and “severe” elbow spasticity were included yet patients with paresis were not excluded. Disparate inclusion criteria could have skewed the overall outcome. As would be expected given the biochemical action of BtxA, maximum benefit appears to be within four months following a single injection.16e18,20,23 Miscio et al19 suggest that increased spasticity is associated with a shorter duration of action of BtxA, and Levy22 found that spasticity returned by 6 months. Consideration has also been given to the use of medications to treat strokerelated spasticity with minimal success. BtxA was compared to Table 2 Modified Ashworth Scale Score

Modified Ashworth Scale

0 1

No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM when the affected part(s) is moved in flexion or extension Marked increase in muscle tone, manifested by a catch in the middle range and resistance throughout the remainder of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension

2

3 4

ROM ¼ range of motion. Reference: Ghotbi et al (2011).13

tizanidine and was shown to be more effective in the treatment of spasticity than tizanidine with fewer adverse effects. Adverse effects attributable to BtxA have been relatively uncommon. Using the dose regimens as covered previously, negative systemic effects have not been seen. Successful and significant reduction in spasticity as measured by the MAS has been shown by multiple authors.19e33 Improvement of at least one MAS grade has been demonstrated in up to 83% of patients treated with BtxA.17 Improvements in pain, range of motion (ROM), strength, and functional use of the upper limb have been reported to be associated with BtxA treatment.16,17,19,20,23,27,34 Some studies include therapy as a part of the study, or reported that concurrent therapy continued during the BtxA intervention. Gallien et al34 reports resolution of Kienbock’s disease in a patient with cerebral palsy using BtxA and orthotic intervention to treat spasticity of the flexor carpi radialis (FCR). Miscio19 measured reduction of disability in 50% of patients treated and also found that 89% of patients with transient spastic symptoms post cerebral infarction benefited by treatment. However, treatment with BtxA has not been uniformly successful. Brashear17 noted a relatively high placebo effect of 27e53% in measures of activities of daily living, spasticity, and pain. Childers18 found no effect of BtxA on measures of pain or functional disability in patients with very severe wrist and severe elbow spasticity and Slawek20 found no effect of BtxA on pain. This contrasts with successful treatment of spasticity-associated pain by Miscio.19 Some studies have demonstrated more effective change in spasticity and function when BtxA is combined with therapeutic interventions than with passive regimens.16,22,24,27e30 Adjunctive therapy has been included in many experimental protocols of BtxA treatment and has been shown to improve outcomes of spasticity, ROM and function to prolong the action of BtxA. However, the role of therapy in addition to BtxA is not always clear. Some authors give small mention to therapy in general, or specifically name hand therapy intervention, yet other studies describe no reproducible specifics of the interventions.18,19,30,32,33 Therapy strategies have included orthotic intervention for both day and night wear, active ROM, passive ROM, home stretching, therapeutic taping, repetitive cyclic arm exercises, and neuromuscular or functional electrical stimulation, as well as functional activities to increase limb participation.16,18,19,21e23,27,29,31 Barus and Kozin,31 in a level 5 article, describe an algorithm post BtxA injection for the management of elbow flexion contracture due to central nervous system injuries, such as cerebral palsy, traumatic brain injury or spinal cord injury. The intervention includes serial elbow extension casting, using unique graduated wedges inserted in the anterior aspect of the antecubiatal fossa of the cast, without removal of the cast. This is followed by passive and active elbow extension exercises, for strength, motor control and incorporating functional activities and participation.

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Two studies outline a specific therapy regimen. Rodriguez-Reyes et al16 identified a lack of specificity of the therapy intervention in the literature. The study was a 6 week, non-randomized pilot study of 8 children (ages 3e6 years) with spastic upper limbs due to cerebral palsy to investigate the effect of the combination of low dose BtxA, 30 min of PT and OT daily, and 10 sessions of 20 min neuromuscular electrical stimulation (NMES) to the wrist extensors. PT included neurofacilitation and neurorelaxation, assisted mobilizations, upper limb and thoracic muscle group PROM. OT included sensori-motor manual activities, body proprioception with reinforcement via mirror image, and daily living activities. They demonstrated a positive trend in spasticity reduction (by a grade of 0.05 MAS), and significant improvement in functional hand performance by 30 s as measured by Jebsen Hand Function Test (JTHF), and an increase in the wrist extension/flexion arc of active ROM by 14.7 mean degrees, and abduction/adduction arc by 17.3 mean degrees. Rodriquez et al24 studied a population of adults with chronic upper extremity hemiplegia for the effect of BtxA in the long finger flexors combined with stretching these same muscles, and training of active wrist and finger extension. A home program was designed which included passive stretching of the long finger flexors combined with active closed-chain weight bearing using a specifically designed hand based, finger abduction weight bearing orthosis. They used an NMES unit for wrist and finger extension, and completed a specific set of functional tasks with the involved arm. The subjects also wore the same orthosis during sleep. This was a small study of 14 subjects, measured at 3 points over 11 months. The study had significant flaws, with a significant drop out rate, with only 2 subjects remaining at the 11 month mark. Results were reported using only raw data with no statistical analysis. However, the results indicated reduction in MAS and clonus, improved finger extension with a neutral positioned wrist, and improved grip strength even at the initial measure, with carryover to the last time measure. Other studies were not as specific in the therapy intervention, but mention it in the study. Pieber et al26 completed a 6 month randomized controlled pilot study comparing the combination of functional electrical stimulation, BtxA versus BtxA as a stand-alone intervention to improve function in 6 children (ages 7e17 years)

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with spastic hemiparesis; 3 in each group. Both groups received OT and a night orthosis, with no specifics mentioned. All the children improved in spasticity by 1e2 MAS grades. Five children improved in passive (PROM) and active (AROM) wrist extension at the 6 month mark (10e25 PROM 10e60 AROM); 4 of the children improved in muscle strength (from 0.5 to 1.5 in the 0e5/5 scale). None of the control group improved in function, yet all of the treatment group improved significantly in function. Miscio et al19 studied the effect of BtxA on wrist ROM, pain, function and “stiffness” (measured by a combination of surface electromyography (sEMG) on wrist muscles and a torque motor at different constant velocities) in 18 adults, consecutively assigned over 6 months. Interestingly, the authors note each patient received “intensive physical therapy” with no mention of the therapy protocol. They report a significant change in the MAS scores for all patients throughout the 6 months, significant wrist extension increase of 15 , and a significant decrease in the amplitudes measured sEMG. They do report a trend toward functional improvement, and of the 3 patients who reported pain with spasticity all reported it was completely relieved. The functional outcome measures were not well described, nor were their psychometric properties for this population elucidated. Other studies of the effect of BtxA on spasticity with reported changes to ROM and functional ability, primarily used only the MAS as their outcome measure to show this change.10,11,32 Best practice has yet to be determined from these studies. For future clinical research, it is highly recommended that a preplanned approach be used, which involves the patient, family, physician and therapist, to determine the goals of intervention, both for functional and ROM gains. Further investigations of the effect of BtxA and therapy interventions should clarify the specific contribution of therapeutic intervention, as it has been found the effect of therapy is not insignificant.21,26e30 A proposed comparison study for the combined approaches is outlined in Fig. 1. Focal dystonia Focal dystonia (FD) is a rare motor disorder defined by prolonged involuntary muscle contractions and abnormal postures initiated by attempts to perform specific tasks. This disorder is also

Fig. 1. Proposed Botox and Therapy Outcomes Research Model.

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known as writer’s cramp, musician’s dystonia, or even in earlier manuscripts as stenographer’s or sportsman’s cramp.35,36 The etiology of FD has yet to be fully defined, but it is thought to have a central mechanism related to abnormal activity in the basal ganglia, specifically the thalamus and putamen, and aberrant signaling radiating to the premotor cortex and to executive motor centers.37,38 Sensory feedback may also play a role in dystonia, as does abnormal posturing. Vibration may worsen symptoms and local anesthetic blocks may temporarily improve them.4,37,39 Byrnes et al37 using transcortical magnetic stimulation, showed bilateral alterations in the location and shape of the cortical representation of two hand muscles in patients with FD and writer’s cramp as compared to normal controls. In some subjects, it appeared that multiple cortical motor sites existed for a single muscle. Because the muscles tested (abductor pollicis longus and the first dorsal interosseous) were not necessarily in themselves involved in dystonic posturing, it suggests that the motor cortex could be adapting to abnormal signal pathways from deeper in the brain.37 Peripheral manifestations, however, lend themselves to peripheral treatments, which include BtxA, oral medications, acupuncture, adaptive aids, physiotherapy, and behavioral interventions.4,35,40 In a study of 144 musicians, 54% (77 musicians) experienced improvement with one of five different treatments: trihexiphenidyl (33% improved), BtxA (49%), pedagogical retraining (50%), technical exercises (56%), and ergonomic changes (63%). BtxA for FD has been used in doses similar to those used for spasticity. Byrnes37 and Lungu41 used 50e100 u of BtxA in affected muscles; Wissel6 and Djebbari42 used 60e80 u of Dysport. Finger flexors are generally treated with lower doses than are the wrist or elbow flexors.6,37,41,42 The duration of action of the injection is similar to that seen in studies of spasticity. Maximum benefit is seen by 3 months post injection.37,41 This was corroborated by Byrnes’ transcranial stimulation study: the abnormal position of the cortical map in patients with FD and writer’s cramp normalized after BtxA injections and drifted back to an abnormal position by 3 months post-injection.37 In several long term studies, patients return to be treated when their symptoms are bothersome. Patients can be treated when symptoms return as treatment with BtxA injection can safely be repeated at intervals of a minimum of three months for at least ten years.35,41e43 Functional outcomes have not been broadly standardized, and there is a fair amount of subjectivity associated with the effects of BtxA on FD. For pianists, only 2 measures are discussed: the Arm Dystonia Disability Scale (ADDS) and the MIDI-based Scale Analysis (MSA). Jabusch developed the latter in an attempt to develop more objective measure for pianists.44 The MSA is described only as an observer-rated measure ranging from 0 ¼ normal, 1 ¼ mild difficulty, 2 ¼ moderate difficulty, 3 ¼ marked difficulty for musician and writing dystonias44 [MIDI is short for Musical Instrument Digital Interface, a file formatting standard used in connections between electronic musical instruments and computers or other related electronic devices, to connect, record and communicate with each other].45 The MSA was designed as an objective measuring of the extent of the dystonia while the piano musician is playing, as other evaluations which occur outside of the specific playing tasks did not or could not capture the extent of the musician’s dystonia. Scales, a basic element of music architecture, often are the earliest affected physical manifestation of dystonia, where crossing-over of the fingers is required. Jabusch found playing of the C-major scale, where there are no black keys played, is most difficult in these patients. He defines the scales: outward scales where the thumb crosses under, going ulnarly; and inward scales, where the fingers cross over the thumb, going radially. Jabusch44 analyzed 8 patients

with FD and 8 healthy persons to compare findings both before and after BtxA. He compared the final results with the ADDS. He demonstrated the MIDI-Scale Analysis (MSA) to be able to differentiate between affected and non-affected players, before and after BtxA intervention, and significance was found between the MSA and ADDS to identify and quantify change in performance. In this small study, he found the MIDI Scale Analysis as a reliable tool to quantify dystonia and the effects of treatment. The Burke-Fahn-Marsden (BFM) scale is a scale of movement and disability severity of dystonias, developed in 1985,46 and found to have good to very good intra- and inter-rater reliability.47 Movement is scaled by examination, and disability scaled by the patient’s subjective rating of 7 activities of daily living (Appendix). The BFM scale was applied by Djebbari42 and they found positive correlation between objective and subjective tests. Significant improvement was noted subjectively and objectively in 73% of patients.42 They also attempted to define predictors of response to BtxA and noted 3 factors were associated with success: 1) a dystonic pattern which combined thumb extension and pronation/ flexion of the forearm and wrist; 2) increased patient age; and 3) lack of dystonic tremor. Most studies have attempted to assess both objective measures as well as subjective measures of effect. Cole et al36 performed a randomized, double-blind placebo-controlled study of the effects of BtxA on ten subjects with FD who had responded successfully to injections in a prior open-label study. Patients were randomized to placebo or BtxA. They were seen two weeks later. If the physician and patient agreed that there was an improvement, the second injection was given 3e4 months later. If there was no mutually agreed-upon benefit, the patient received a BtxA injection. Response in this early study assessed outcomes 3 ways: subjective patient ratings, objective strength measure and physicians’ rating of performance. Patients rated their subjective improvement and weaknesses with verbal descriptions on a 4 point scale (none, mild, moderate, and major), as well as on an 11 point (0e10) visual analogue scale (VAS). Objective measures of muscle strength were recorded using the British Medical Research Council Scale.1 Performance for writers was a writing sample, graded by time and errors. Performance for musicians was playing a sample of music, graded on a 10 point scale by other musicians blinded to the treatment group. All performances of both writers and musicians were video-analyzed by neurologists blinded to the treatment group. In the treatment group, 8 had a successful response to BtxA. In the placebo group, 6 had no response, 3 had minimal improvement, and 1 had major improvement. In the treatment group, 70% of subjects were weaker, not an unexpected finding. Given that all subjects had responded to BtxA when treated in an open-label fashion, there is a placebo effect of 10e30%. Musicians’ performances did appear to improve when rated by other musicians.36 Kruisdijk et al43 randomized 40 subjects to BtxA or placebo and assessed them primarily for their desire to continue being treated at the 3 month time point. Of those receiving BtxA, 70% felt that they had received benefit, and 32% of those in the placebo group initially demonstrated improvement. At the end of a year, 50% of subjects were still participating.43 Turjanski et al35 used patientrated subjective improvement and pain scores as primary outcomes measures. Of 45 patients, 29 did not feel that they had significantly benefited and did not complete the study. The remaining stated that they had improved ability to write and a marked reduction in pain. Again, weakness was common and

1 Medical Research Council. Aids to the examination of the peripheral nervous system. 1976. Memorandum No. 45, London. Accessed online May 15, 2013 from http://www.medicalcriteria.com/site/index.php?option¼com_content&view¼ article&id¼238%3Aneuromrc&catid¼64%3Aneurology&Itemid¼80&lang¼en.

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caused some functional impairment.35 These findings were corroborated by Wissel et al6 who showed improvements of greater than 20% in dystonia, posture, tremor, and writing speed in 76% of 31 patients and some weakness in 87%. Five of the 31 had no benefit after three injections and so dropped out of the study. While BtxA injections alone have temporarily improved FD, more recent studies have found behavioral training, sensorimotor retraining, graded motor imagery, and ergonomic interventions have also demonstrated a positive effect, without and with the addition of BtxA. Schenk et al,48 in a case-controlled series of 50 right-handed FD patients, of which, only 1 had previously received BtxA for the condition, used a behavioral writing training approach. The results showed improved long term writing performance (up to 48 months), measured by computerized, digitized writing tablet. While this was positive, the authors suggested this approach also be used as a supplement to BtxA. For persons with musician’s dystonia, Frucht49 suggests a combination of BtxA and physiotherapy and a full medical and psychological history including complete details of the onset of the dystonia. Given the potential for negative effects on their careers, he suggests that musicians are highly motivated to participate in therapy.49 The therapist should consider all differential diagnoses when first evaluating patients with a purported diagnosis of FD. The initial visits should include patient specific outcome measures validated for hand conditions, such as the Disabilities of the Arm, Shoulder and Hand (DASH), or its short form, QuickDASH, Patient rated Wrist and Hand Evaluation (PRWHE),50 the Patient Specific Functional Scale,51 the Canadian Occupational Performance Measure (COPM),52 or other outcomes which measure change after hand therapy. Persons with musician’s dystonia should bring the musical instrument to the clinic for a complete assessment of the occupational dystonia. Dystonias are typically painless, with lack of control or co-contractions noted as chief complaints. If manifestations of dystonia soon after the initiation of playing or doing the task-specific to their complaint of dystonia, other causes should be considered, such as radiculopathy, peripheral neural compressions, or other central or musculoskeletal impairments, i.e., Parkinson’s disease or essential tremor. If there is evidence of focal weakness or muscle atrophy, or accompanying pain and sensory findings, then EMG or magnetic resonance imaging (MRI) may be necessary to clarify source of the weakness. If a true dystonia is identified, then discovering what specifically triggers the abnormal postures and what specific compensatory techniques the patient has already employed is helpful. If BtxA is part of the medical plan, then preplanning through either manually preventing the movement, a trial of various textile taping techniques, or finger orthoses which prevent or partially restrain the aberrant movement. If this assists in restoring a sense of control during their dystonic task, then it may add to the decision making for which muscles might benefit by being injected.49 The manifestation of FC occurs after skill acquisition, in all taskspecific dystonias. Since FD seems to have a multi-modal, but yet unknown, specific cause it seems the most appropriate intervention for FD be multi-modal; in the sensorimotor, neurophysiology, psychosocial and behavioral and pharmacology realms.53 Oftentimes therapists have more opportunity than physicians to devote to the functional aspect of care. Hand therapists can assist the assessment of how the various modes of medical intervention affect the person in all areas of occupation for in occupational and functional activity participation. An ideal patient-centric approach is a team approach, in which the person seeking care for FD would be assessed functionally, identifying the goals of intervention, with all medical and therapeutic interventions planned around these goals.

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Vasospastic disorders Raynaud’s disease is a condition characterized by symmetrical cold intolerance and transient color changes. Raynaud’s phenomenon is more severe and is associated with trophic changes, ulcers, asymmetry and abnormal angiography. When Raynaud’s phenomenon is associated with other systemic conditions such as collagen vascular diseases, trauma, medications, and cancer, it is called Raynaud’s syndrome.54e56 Raynaud’s disease is generally managed by avoiding cold temperatures, but Raynaud’s phenomenon is generally more painful and problematic and requires treatment by a variety of means including smoking cessation, oral medications such as calcium channel blockers, topical nitrates, surgical sympathectomies, cold avoidance, biofeedback, and, most recently injection of the wrist, palm, and/or digits with BtxA. Van Beek et al56 reviewed their experience treating eleven patients with Raynaud’s phenomenon. All had failed multiple modes of therapy, and eight were eventually hospitalized for pain control with intravenous (IV) prostacyclin as well as management of open wounds. Each involved hand was injected subfascially with 100 u BtxA, 8e12 units at 8e10 sites. Magnetic resonance angiography or digital angiography was performed prior to injections to ruleout proximal stenotic areas which could be treated by a vascular surgery bypass. Follow-up ranged from 10 to 30 months and all patients responded favorably to the injections with healing of small ulcers, resolution of trophic changes, and significant reduction of pain from 9e10/10 to 0e2/10. Skin temperature of the finger tips increased by several degrees in the weeks following the injections. Repeat injections have been done in five patients as symptoms recurred. One patient had four injections. Other than mild weakness in three of the eleven patients, there were no complications noted. The charts of 19 patients with Raynaud’s phenomenon were retrospectively reviewed by Neumeister et al.54 The patients they reviewed were considered for treatment if they had chronic ischemic changes and hand pain. As in the patient population studied by Van Beek et al56 pre-injection angiography was performed. Laser Doppler measurement of tissue perfusion was also performed in 14/19 patients. A total of 50e100 u BtxA was injected into the palm, but unlike Van Beek et al56 who injected all fingers in nine of eleven patients and only injected thumbs if symptomatic, only obviously involved digits were injected by Neumeister.54 Possibly for this reason, only 16/19 experienced immediate relief of their pain. Three had little to no short term relief of symptoms but gradually improved over a two month period. All ulcers healed. Four patients required repeat injections for recurrence of symptoms. Laser Doppler measurements showed a rapid improvement in digital blood flow (within 30 min) in 70% of patients. As has been found in other patient groups, weakness is a side effect of injection. In this study, two patients developed transient (2 month) weakness of their intrinsic muscles. Fregene et al55 in 2009 published a retrospective chart review of 26 patients treated with BtxA for Raynaud’s phenomenon. The modal dose was 100 u with a range of 10e100 u per encounter, and 83% of injections were performed in the distal palm. The primary outcomes of pain, color, transcutaneous oxygen (TCO2), and wound healing from the initial study date to the time of complete wound epithelialization were recorded for all patients. Pain relief was significant in 75% of patients, dropping from 8 to 5.2/10 on the VAS scale. 57% of encounters resulted in improved TCO2 and the color of the digit improved in 31/55 encounters. An improvement in color was more commonly noted in females and smokers. Ulcers healed within 9.5 weeks in 11/23 patients. There were 9 treatment failures (no improvement within 1 month). Six

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patients had transient hand weakness which resolved by five months following the injection. The focus of hand therapy intervention for vasospastic disorders even with BtxA injections, as BtxA is temporary, includes a behavioral educational approach, with behavioral modification and self-care instruction regarding the care of the hands in all situations. Hand therapy interventions for Raynaud’s disease includes instruction in hand care, keeping hands and the body warm, as well as biofeedback for skin temperature self-regulation. Behavioral studies57,58 show significant results in self regulation of hand temperature using thermistors (a biofeedback unit with transducers) attached to the finger tips. Thermistors are fairly inexpensive and can be purchased for clinical and personal use (www.cliving. org/stressthermometer.htm or http://bio-medical.com/products/ stress-thermometer-sc911.html). Other therapeutic considerations include orthotic protection of ischemic fingers, instruction in management of wound healing and scars, maintenance or restoration of ROM for stiff joints, and desensitization of healing finger tips. All areas of occupation should be assessed with the patient for functional deficits during healing, or due to loss of digital length, or parts of the hand. When digital ulcers do occur, they are painful and limit functional hand use. The clinician should not overlook patient education in the use of adaptive equipment and techniques, protective padding for the fingers, such as CobanÔ elastic wraps (3M, St. Paul, MN), neoprene finger sleeves, or gloves with non-affected glove-fingers tucked inside or removed from the glove. In addition, padded surfaces for instruments or tools used for daily tasks may be needed. If there are multiple ulcers, thin cotton gloves to protect the hand can be useful.59 Loss of finger cosmesis including length and deformity of the hands are devastating occurrences. Psychological intervention may also be needed. Further involvement with a prosthetics provider may assist in restoring cosmesis. Again, the hand therapist works as a team with the patient and the physician to address patient identified goals of intervention. For persons with vasospastic conditions, the priorities are to monitor wound healing, provide orthoses for protection and maintenance of ROM, restore functional use of the hand, instruct in the safety of hand use, and adaptive needs as addressed and identified with the patient.

determined. Tessler and Lessard64 treated eight patients with chronic regional pain syndrome (CRPS-I) with subcutaneous BtxA every four weeks for an average of 9.5 treatments (range 5e13). Pain scores were measured on an 11 point scale. The patients worked with a hand therapist throughout the duration of BtxA treatment. Average pain scores were reduced by 31%, and results were maintained for over a year.63 This was a prospective study and has the usual limitations of small group size and no control group. Birthi et al65 also documented success in treating the CRPS-I of a single patient with subcutaneous BtxA. The patient was treated with 100 u distributed over 20 sites on the dorsal hand. Pain decreased over the first 4 weeks, and the improvement was maintained for an additional month. By the 12th week following injection, the pain was at baseline. The range of motion of the wrist and digits improved shortly after injection, and much of this improvement was maintained.65 In their retrospective chart review, Kharkar et al66 studied 37 patients with CRPS who had BtxA injections in the neck and shoulder girdle. Each involved muscle was injected with 10e20 u using EMG guidance. The pain scores dropped from 8.2 (range 7e 10) to 4.5 (range 2e8), a significant difference, and one noted by 97% of patients. One patient developed neck weakness but there were no other complications. All studies of BtxA for CRPS in the upper extremity to date are relatively small but early data are promising for this challenging group of patients. The body of evidence points to positive changes in pain using a therapeutic approach. An emerging body of evidence regarding improvement in chronic pain revolves around graded motor imagery (GMI) or mirror therapy. Bowering et al67 found in their very recent systematic review (SR) and metaanalysis of GMI and mirror therapy that while the evidence is limited, results suggest this intervention alone may be effective. However, their SR did not include studies with BtxA. Ovens and Dewar68 report a case study of a man with bilateral CRPS who responded positively with BtxA to one of the involved hands added to a course of care which included a physiotherapy routine. However, the physiotherapy routine is not specified. Coordinating BtxA and therapeutic interventions in patients with CRPS is ripe for further investigation and research. Complications and risks of Botox

Pain conditions BtxA has long been recognized to have analgesic effects in its use in other upper extremity conditions, but it is not clear whether the effect is direct or indirect.17,19,35,54e56 There may be direct effects on vascular smooth muscle or it may have a direct analgesic action. Chronic pain may be related to sensitization of nerves in the peripheral and central nervous system. Because BtxA may inhibit sensitization, relieve neural inflammation, and relax muscle, interest has grown in co-opting BtxA for use in the treatment of chronic pain.60 Safarpour et al61 treated two patients with unilateral arm chronic regional pain syndrome (CRPS) with 200 and 240 u BtxA respectively with excellent and sustained pain reduction and reversal of sudomotor signs. In a second study, they found no effect of BtxA on pain in a group of eight patients; but this group had much more severe CRPS present in each patient in all limbs and the total dose was less than half that of the dose used in their other smaller case series.62 Argoff63 treated 11 patients with unilateral shoulder CRPS with 25e50 u of BtxA. In this observational study, all patients reported less pain, less burning, and normalization of color and edema. Because of the small numbers of patients studied, whether to inject BtxA subcutaneously or intramuscularly has not yet been

Patients have been shown to safely tolerate repeated injections of up to 70 units of BtxA per episode for up to 20 years in studies of botulinum toxin A used for blepharospasm and hemifacial spasms.69,70 The dose required for effect may need to be increased over time.70 The formation of neutralizing antibodies against BtxA has been proposed to be a potential cause of treatment failure related to factors such as prolonged duration of treatment, large doses per treatment, and short intervals between injections, but this has not been supported in long-term studies.71,72 The rate of seroconversion was shown by Charles to be 2%, but as the study subjects still responded to BtxA, the significance of seroconversion has yet to be fully defined.73 Overall, complications associated with BtxA injections are low with very rare “major” adverse effects (dysphagia, respiratory difficulty, or systemic diffusion) and minor adverse effects ranging from 5 to 20% (local injection pain, local diffusion). They do not appear to increase over time.69,74,75 Conclusion The research evidence is gradually mounting to support the hypothesis that the action of BtxA is not limited to skeletal muscle. It also appears to affect function of smooth muscle, decrease neurologic inflammation, and decrease the activity of sensitized

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pain fibers.65 In complex hand and upper extremity conditions which have responded poorly to standard treatment paradigms, BtxA may be an alternative. Despite its relatively short period of action and need for repeat treatments, it has a low rate of complications, patients tolerate repeat injections, and it has a rapid onset Additional multicenter research is indicated to better determine optimal dosing, sites of injection, indications, contraindications, and predictors of success. Multi-modal hand therapy intervention has a limited, but beginning, body of evidence to demonstrate significance in combination with BtxA for selected hand conditions. Further studies on patients with conditions that benefit from BtxA should be well defined to determine the combined effect of BtxA and therapy.

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Effect of repetitive arm cycling following botulinum toxin injection for poststroke spasticity: evidence from FMRI. Neurorehabil Neural Repair. 2010;24(8):753e762. 28. Chang CL, Munin MC, Skidmore ER, Niyonkuru C, Huber LM, Weber DJ. Effect of baseline spastic hemiparesis on recovery of upper-limb function following botulinum toxin type A injections and postinjection therapy. Arch Phys Med Rehabil. 2009;90(9):1462e1468. 29. Hesse S, Reiter F, Konrad M, Jahnke MF. Botulinum toxin type A and short-term electrical stimulation in the treatment of upper limb flexor spasticity after stroke: a randomized, double-blind, placebo-controlled trial. Clin Rehabil. 1998;12:381e388. 30. Kaji R, Osako Y, Suyama K, Maeda T, Uechi Y, Iwasaki M. Botulinum toxin type A in post-stroke upper limb spasticity. Curr Med Res Opin. 2010;26(8):1983e1992. 31. Barus D, Kozin SH. The evaluation and treatment of elbow dysfunction secondary to spasticity and paralysis. J Hand Ther. 2006;19:192e205. 32. Munin NC, Navalgund BK, Levitt DA, Breisinger TP, Zafonte RD. Novel approach to the application of botulinum toxin to the flexor digitorum superficialis muscle in acquired brain injury. Brain Inj. 2004;18(4):403e407. 33. Francisco GE, Boake C, Vaughn A. Botulinum toxin in upper limb spasticity after acquired brain injury: a randomized trial comparing dilution techniques. Am J Phys Med Rehabil. 2002;81(5):355e363. 34. Gallien P, Candelier G, Nicolas B, et al. Kienbock’s disease and cerebral palsy case report. Ann Phys Rehabil Med. 2009;53:118e123. 35. Turjanski N, Pirtosek Z, Quirk J, et al. Botulinum toxin in the treatment of writer’s cramp. Clin Neuropharmacol. 1996;19(4):314e320. 36. Cole R, Hallett M, Cohen LG. Double-blind trial of botulinum toxin for treatment of focal hand dystonia. Mov Disord. 1995;10(4):466e471. 37. Byrnes ML, Thickbroom GW, Wilson SA, et al. The corticomotor representation of upper limb muscles in writer’s cramp and changes following botulinum toxin injection. Brain. 1998;121(Pt 5):977e988. 38. Dresel C, Bayer F, Castrop F, et al. Botulinum toxin modulates basal ganglia but not deficient somatosensory activation in orofacial dystonia. Mov Disord. 2011;26(8):1496e1502. 39. Naumann M, Reiners K. Long-latency reflexes of hand muscles in idiopathic focal dystonia and their modification by botulinum toxin. Brain. 1997;120: 409e416. 40. Jabusch HC, Zschucke D, Schmidt A, Schuele S, Altenmuller E. Focal dystonia in musicians: treatment strategies and long-term outcome in 144 patients. Mov Disord. 2005;20(12):1623e1626. 41. Lungu C, Karp BI, Alter K, Zolbrod R, Hallett M. Long-term follow-up of botulinum toxin therapy for focal hand dystonia: outcome at 10 years or more. Mov Disord. 2011;26(4):750e753. 42. Djebbari R, du Montcel ST, Sangla S, Vidal JS, Gallouedec G, Vidailhet M. Factors predicting improvement in motor disability in writer’s cramp treated with botulinum toxin. J Neurol Neurosurg Psychiatry. 2004;75(12):1688e1691. 43. Kruisdijk JJ, Koelman JH, Ongerboer de Visser BW, de Haan RJ, Speelman JD. Botulinum toxin for writer’s cramp: a randomised placebo-controlled trial and 1-year follow-up. J Neurol Neurosurg Psychiatry. 2007;78(3):264e270. 44. Jabusch HC, Vauth H, Altenmuller E. Quantification of focal dystonia in pianists using scale analysis. Mov Disord. 2004;19(2):171e180. 45. Swift Andrew. “A Brief Introduction to MIDI,” SURPRISE (Imperial College of Science Technology and Medicine). May-Jun 1997. accessed 10.09.13. 46. Burke RE, Fahn S, Marsden CD, Bressman SB, Moskovitz C, Friedman J. Validity and reliability of a rating scale for the primary torsion dystonias. Neurology. 1985;35(1):73e77. 47. Krystkowiak P, du Montcel ST, Vercueil L, et al. Reliability of the Burke-FahnMarsden scale in a multicenter trial for dystonia. 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53. Lin PT, Hallett M. The pathophysiology of focal hand dystonia. J Hand Ther. 2009;22:109e114. 54. Neumeister MW, Chambers CB, Herron MS, et al. Botox therapy for ischemic digits. Plast Reconstr Surg. 2009;124:191e200. 55. Fregene A, Ditmars D, Siddiqui A. Botulinum toxin type A: a treatment option for digital ischemia in patients with Raynaud’s phenomenon. J Hand Surg. 2009;34(3A):446e452. 56. Van Beek AL, Lim PK, Gear AJL, Pritzker MR. Management of vasospastic disorders with botulinum toxin A. Plast Reconstr Surg. 2007;119(1):217e226. 57. Keefe FJ, Surwit RS, Pilon RN. Biofeedback, autogenic training, and progressive relaxation in the treatment of Raynaud’s disease: a comparative study. J Appl Behav Anal. 1980;13(1):3e11. 58. Grimsley DL, Karriker MW. Bilateral skin temperature, handedness, and the biofeedback control of skin temperature. J Behav Med. 1996;19(1):87e94. Abstract, accessed 18.05.13. 59. Melvin JL. Scleroderma (Systemic Sclerosis): treatment of the hand. In: Skirven TM, Osterman AL, Fedorczyk JM, Amadio PC, eds. Rehabilitation of the Hand and Upper Extremity. 6th ed. Philadelphia, PA: Elsevier Mosby; 2012. Accessed 18.05.13. 60. Ranoux D, Attal N, Morain F, Bouhassira D. Botulinum toxin type A induces direct analgesic effects in chronic neuropathic pain. Ann Neurol. 2008;64:274e283. 61. Safarpour D, Jabbari B. Botulinum toxin A (Botox) for treatment of proximal myofascial pain in complex regional pain syndrome: two cases. Pain Med. 2010;11(9):1415e1418. 62. Safarpour D, Salardini A, Richardson D, Jabbari B. Botulinum toxin A for treatment of allodynia of complex regional pain syndrome: a pilot study. Pain Med. 2010;11(9):1411e1414. 63. Argoff CE. A focused review on the use of botulinum toxins for neuropathic pain. Clin J Pain. 2002;18(6 suppl):S177eS181. 64. Tessler O, Lessard L. Botox: a novel therapeutic modality for post-hand trauma CRPS-RSD. Plast Reconstr Surg. 2009;124(4S):79. 65. Birthi P, Sloan P, Salles S. Subcutaneous botulinum toxin A for the treatment of refractory complex regional pain syndrome. Phys Med Rehabil. 2012;4(6): 446e449.

66. Kharkar S, Ambady P, Venkatesh Y, Schwartzman RJ. Intramuscular botulinum toxin in complex regional pain syndrome: case series and literature review. Pain Physician. 2011;14(5):419e424. 67. Bowering KJ, O’Connell NE, Tabor A, et al. The effects of graded motor imagery and its components on chronic pain: a systematic review and meta-analysis. J Pain. 2013;14(1):3e13. 68. Ovens L, Dewar D. Use of botulinum toxin in complex regional pain syndrome in the hand. Eur J Plast Surg. 2013;36(1):37e39. 69. Czyz CN, Burns JA, Petrie TP, Watkins JR, Cahill KV, Foster JA. Long-term botulinum toxin treatment of benign essential blepharospasm, hemifacial spasm, and Meige syndrome. Am J Ophthalmol. 2013;156(1):173e177. 70. Ababneh OH, Cetinkaya A, Kulwin DR. Long-term efficacy and safety of botulinum toxin a injections to treat blepharospasm and hemifacial spasm. Clin Experiment Ophthalmol. doi: http://dx.doi.org/10.1111/ceo.12165. [Epub ahead of print]. 71. Bakheit AM, Liptrot A, Newton R, Pickett AM. The effect of total cumulative dose, number of treatment cycles, interval between injections, and length of treatment on the frequency of occurrence of antibodies to botulinum toxin type A in the treatment of muscle spasticity. Int J Rehabil Res. 2012;35(1): 36e39. 72. Benecke R. Clinical relevance of botulinum toxin immunogenicity. BioDrugs. 2012;26(2):e1ee9. 73. Charles D, Brashear A, Hauser RA, Li HI, Boo LM, Brin MF, CD 140 Study Group. Efficacy, tolerability, and immunogenicity of onabotulinumtoxin a in a randomized, double-blind, placebo-controlled trial for cervical dystonia. Clin Neuropharmacol. 2012;35(5):208e214. 74. Esquenazi A, Mayer N, Lee S, et al, PROS Study Group. Patient registry of outcomes in spasticity care. Am J Phys Med Rehabil. 2012;91(9): 729e746. 75. Thomas AM, Simpson DM. Contralateral weakness following botulinum toxin for poststroke spasticity. Muscle Nerve. 2012;46(3):443e448. 76. Kane RL. Why look at outcomes. In: Kane RL, ed. Understanding Health Care Outcomes Research. 2nd ed. Sudbury, MA: Jones and Bartlett; 2006: 3e22.

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Appendix. Burke-Fahn-Marsden Dystonia Scale.46x

This scale consists of provoking factors (scored 0e4) and severity factors (scored 0e4). Some are given a weight of ½, and others a weight of 1. All three are multiplied to given the adjusted score; all scores are summed to give an overall score from 0 to 120.

Movement scale: [scored by clinician]

Provoking factors General 0 1 2 3 4

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No dystonia at rest or with action Dystonia on particular action Dystonia on many actions Dystonia on action of distant part of body, or intermittently at rest Dystonia present at rest

Speech and swallowing 0 1 2 3

None Occasional, either or both Frequent, either Frequent one, occasional other

Severity factors Eyes 0 1 2 3 4 Mouth 0 1 2 3 4 Speech and swallowing 0 1 2 3 4 Neck 0 1 2 3 4 Arm 0 1 2 3 4 Trunk 0 1 2 3 4 Leg 0 1 2 3 4

None Slight. Occasional blinking Mild. Frequent blinking without prolonged spasms of eye closure Moderate. Prolonged spasms of eyelid closure, but eyes open most of the time Severe. Prolonged spasms of eyelid closure, with eyes closed at least 30% of the time No dystonia present Slight. Occasional grimacing or other mouth movements (e.g. jaw open or clenched; tongue movement) Mild. Movement present less than 50% of the time Moderate dystonic movement or contractions present most of the time. Severe dystonic movement or contractions present most of the time. Normal Slightly involved; speech easily understood or occasional choking Some difficulty in understanding speech of frequent choking Marked difficulty in understanding speech of inability to swallow firm foods Complete or almost complete anarthria, or marked difficulty swallowing soft foods or liquids No dystonia present Slight. Occasional pulling Obvious torticollis, but mild Moderate pulling Extreme pulling No dystonia present Slight dystonia. Clinically insignificant Mild. Obvious dystonia but not disabling Moderate. Able to grasp, with some manual function Severe. No useful grasp No dystonia present Slight bending; clinically insignificant Definite bending but not interfering with standing or walking Moderate bending; interfering with standing or walking Extreme bending of trunk preventing standing or walking No dystonia present Slight dystonia but not causing impairment; clinically insignificant Mild dystonia. Walks briskly and unaided Moderate dystonia. Severely impairs walking or requires assistance Severe. Unable to stand or walk on involved leg

Scoring: Movement Scale Region

Provoking factor (PF)

Eyes Mouth Speech/swallowing Neck Right arm Left arm Trunk Right leg Right leg

0e4 0e4 0e4 0e4 0e4 0e4 0e4 0e4 0e4

X X X X X X X X X

Severity factor (SF)

Weight (W)

Score (product of (PF  SF)  W ¼ score

0e4 0e4 0e4 0e4 0e4 0e4 0e4 0e4 0e4

0.5 0.5 1 0.5 1 1 1 1 1 Total (sum: maximum 120)

0e8 0e8 0e16 0e8 0e16 0e16 0e16 0e16 0e16

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Disability Scale: this is the portion that is patient-rated on 7 aspects of Activities of Daily Living. The higher the score, the higher the disability.

Dystonia Disability Scale

Score

Speech 0 Normal 1 Slightly involved, easily understood 2 Some difficulty in understanding 3 Marked difficulty in understanding 4 Complete or almost complete anarthria Handwriting 0 Normal 1 Slight difficulty; legible 2 Almost illegible 3 Illegible 4 Unable to grasp to maintain hold on pen Feeding 0 Normal 1 Uses “tricks”; independent 2 Can feed but not cut 3 Finger food only 4 Completely dependent Eating/swallowing 0 Normal 1 Occasional choking 2 Chokes frequently; difficulty in swallowing 3 Unable to swallow firm foods 4 Marked difficulty swallowing soft foods and liquids Hygiene 0 Normal 1 Clumsy; independent 2 Needs help with some activities 3 Needs help with most activities 4 Needs help with all activities Dressing 0 Normal 1 Clumsy; independent 2 Needs help with some activities 3 Needs help with most activities 4 Helpless Walking 0 Normal 1 Slightly abnormal; hardly noticeable 2 Moderately abnormal; obvious to naive observer 3 Considerably abnormal 4 Needs assistance to walk 6 Wheel-chair bound Total Scoring: Disability scale Function

Score

Speech Writing Feeding Eating Hygiene Dressing Walking Score: sum (maximum ¼ 30)

0e4 0e4 0e4 0e4 0e4 0e4 0e6

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JHT Read for Credit Quiz: #302

Record your answers on the Return Answer Form found on the tear-out coupon at the back of this issue or to complete online and use a credit card, go to JHTReadforCredit.com. There is only one best answer for each question. #1. BTxA is a neurotoxin causing a. temporary muscle paralysis at the anterior horn cell b. permanent paralysis at the anterior horn cell c. temporary muscle paralysis at the neuromuscular junction d. permanent muscle paralysis at the neuromuscular junction #2. The pruning back of sprouts in this article refers to a. local nerve fibers growing into muscle tissue b. central nerve fibers growing into major peripheral nerve trunks c. microsurgical trimming of unwanted nerve buds d. microsurgical harvesting of fresh nerve endings for grafting #3. BTxA may be helpful in the management of a. cubital tunnel syndrome b. trigger finger

c. Dupuytren’s d. focal dystonia #4. BTxA administration is usually assisted by a. a physician’s assistant b. flouroscopy c. EMG d. a hand therapist #5. One drawback for the use of BTxA is the high rate of complications a. true b. false When submitting to the HTCC for re-certification, please batch your JHT RFC certificates in groups of 3 or more to get full credit.

Current uses of botulinum toxin A as an adjunct to hand therapy interventions of hand conditions.

Literature review...
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