INFLUENCE OF FOOT ORTHOTICS UPON DURATION OF EFFECTS OF SPINAL MANIPULATION IN CHRONIC BACK PAIN PATIENTS: A RANDOMIZED CLINICAL TRIAL Anthony L. Rosner, PhD, a Katharine M. Conable, DC, b and Tracy Edelmann, DC c

ABSTRACT Objective: The purpose of this study was to investigate the effects of 4 weeks of custom foot orthotics on pain, disability, recurrence of spinal fixation, and muscle dysfunction in adult low back pain patients receiving limited chiropractic care. Methods: Adult volunteers with low back pain of greater than or equal to 1 month's duration were randomized to receive custom orthotics (group A) or a flat insole sham (group B) with limited chiropractic care in 5 visits over 4 weeks. Primary outcome measures are as follows: Quadruple Numerical Pain Rating Scale (for back), the RolandMorris Disability Questionnaire, the number of muscles grade 4 or lower on manual muscle testing, and the number of spinal fixations detected by motion palpation and vertebral challenge at intake (B1), 2 weeks later before treatment began and orthotic use was initiated (B2) and before each subsequent treatment at approximately days 3, 10, 17, and 24 after B2. Secondary outcome measures are correlations of all primary outcomes. Results: Both groups improved on all Numerical Pain Rating Scale, Roland-Morris Disability Questionnaire, and the number of muscles from intake (B1) to final visit. Only group B yielded significant improvements in the number of spinal fixations. No outcome measures showed statistical difference between groups at any time point; however, those who wore custom orthotics longer each day showed trends toward greater improvements in some outcome measures. Conclusions: Both groups improved with chiropractic care including spinal manipulation; however, there were no statistical differences shown between sham and custom orthotic groups. Future studies should formally measure the time that orthotics or shams are worn in a weight-bearing capacity each day. (J Manipulative Physiol Ther 2014;37:124-140) Key Indexing Terms: Orthotic Devices Manipulation; Spinal Manipulation; Kinesiology; Applied Back Pain; Pain Assessment; Outcomes Assessment (Health Care); Chiropractic

he joints at the lower extremities and the pelvis are considered to be fundamental to posture and biomechanical function. These include the feet and ankles, which support the entirety of the body, and the sacral base. Irwin 1 identified 4 elements, which are capable

T a

Research Director, International College of Applied Kinesiology, Shawnee Mission, KS. b Associate Professor, Chiropractic Division, Logan University/ College of Chiropractic, Chesterfield, MO. c Private Practice, Wildwood, MO. Dr Anthony Rosner is contracted as Research Director by the International College of Applied Kinesiology–USA. No other conflicts of interest were reported for this study. Submit requests for reprints to: Anthony L. Rosner, PhD, LLD [Hon], 1330 Beacon St, Suite 315, Brookline, MA 02446-3202 (e-mail: [email protected]). Paper submitted November 5, 2012; in revised form October 30, 2013; accepted November 1, 2013. 0161-4754/$36.00 Copyright © 2014 by National University of Health Sciences. http://dx.doi.org/10.1016/j.jmpt.2013.11.003

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of reducing more than two-thirds of common pain occurrences: (1) manual manipulation to reduce somatic dysfunction; (2) foot orthotics to optimize the amplitude of the arches of the feet as well as vertically aligning the ankle; (3) a heel lift to level the sacral base; and (4) a set of therapeutic postures, which are designed to minimize the restrictions of peripheral soft tissue reflective of the earlier posture. To these elements has been added the finding that electromyographic changes occur with the use of foot orthotics, documenting the importance of studying muscle activity as a reaction to shoe inserts and foot orthoses. 2 These observations suggest a rationale for including the following 3 elements in an investigation of chronic back pain:

SPINAL FUNCTION As assessed and managed by chiropractic, the condition and response of the spine to treatment have been widely described, the most robust research having been reported over the past 20 years. 3-5

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ACTIVITY

OF THE

FOOT

AND ITS

MANAGEMENT

Foot orthotics may successfully modify selected aspects of lower extremity mechanics and enhance foot stability. Recent investigations have demonstrated that custom-fit orthotics may restrict undesirable motion at the foot and ankle, enhancing detection of perturbations by joint mechanoreceptors and providing structural support for controlling postural sway in ankle-injured subjects. 6 A recent systematic review concluded that foot orthotics increased activation of the tibialis anterior and peroneus longus and might have altered lower limb and back muscle activation. Changes in electromyographic activation were reported as well, although standards for reporting these were found wanting when confidence intervals were calculated. 7 The effectiveness of custom-fit foot orthotics in promoting ankle stability and alleviating foot, ankle, and leg pain has been reported in 35 clinical trials, case series, and case studies involving patients with foot and lower limb pain, juvenile idiopathic arthritis, rheumatoid arthritis, plantar fasciitis, cavus (high arch pain), inversion ankle sprain, Morton neuroma, hallux valgus, and patellofemoral pain. 8-39 In some instances, orthotics were used in combination with other conservative, noninvasive therapies, 8,11,17,20,24,32,36,38,39 often involving spinal manipulation. 9,11,17,24,32,39-42 Studies suggested that pain and disability scales associated with low back pain (LBP) resolved with the use of orthotics. 9,11,12,40-42 A case series reported that orthotics produced a 2-fold extension of the duration of improvements produced by orthopedic manipulation for back pain. 9 A crossover randomized trial feasibility study demonstrated that comparable improvements in pain and disability occurred during the first 6 weeks of wearing orthotics, regardless of whether orthotics were used immediately after randomization or after a 6-week waiting period. However, further improvements after the initial 6 weeks were not found. 12 Shoe inserts may be used as a preventive measure. The incidence of stress fractures and pain at different locations was reduced by 1.5% to 13.4% with the use of shoe inserts. 43 Furthermore, differences in comfort ratings were found to be significantly related to foot arch height, foot and leg alignment, and foot sensitivity concerning the use of insoles 43 as well as possibly influencing fatigue and the development of injuries as far as shoes were concerned. 44

MANUAL MUSCLE TESTING Before the 1980s, manual muscle testing (MMT) as a method for diagnosing spinal dysfunction was seldom recognized in orthodox medical circles. However, the reliability and validity of MMT as originally envisioned by Goodheart 45 with elaborations by Walther 46 and designat-

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ed as applied kinesiology (AK) have recently reported in the literature, 47 together with assessments of its strengths, weaknesses, distinctions in practice, and criticisms. 48 Manual muscle testing is a commonly used method for documenting impairments in muscle strength and may be an adjunct for assessing spinal function. A 2003 survey of doctors of chiropractic by the National Board of Chiropractic Examiners indicated that 37.6% of respondents in the United States used AK in 2003, 49 with similar numbers having been reported in the past from Australia 50 and other reports. 51 Kendall and Kendall 52 described “break testing,” where a muscle tested from a contracted position against increasing applied pressure by the examiner could either maintain its position or “break away.” They discussed a variety of numerical grading systems. 52 In AK, muscles that maintain their position are graded as facilitated or “strong (5/5),” whereas those that break away are classified as inhibited or “weak (4/5 or less).” 45 For AK evaluation, muscle strength per se is not regarded to be a notable issue with clinical syndromes and is not considered to be a factor in back pain or the onset of chronicity. 53-57 Rather, AK uses MMT to identify an imbalance of muscles in which one set of muscles tends to become overactivated while another group becomes inhibited. 58 Janda 59 argued that this phenomenon was not readily explainable by anatomical, histologic, biochemical, or physiologic attributes of the muscle itself. Instead, the terms facilitated or overactive referred to the neurologic state of the muscle in its response to MMT. 59 Inhibition of muscles, especially those that have a stabilization role, has been identified in some persons with spinal complaints. 60-63 The theory in AK is that, if the central nervous system does not activate muscles at the right moment to the correct magnitude and in harmony with other muscles involved in the activity, dysfunction and microtrauma may result. Added to the tenets of contemporary AK is that multiple muscle tests are performed in a series or parallel manner before any diagnosis is ever made. At present, no randomized clinical trials exist that evaluate the use of foot orthotics to support and/or extend the beneficial effects of spinal manipulation. The only reports that designate the combination of spinal manipulation with foot orthotics to manage back pain are a single case study 11 and 1 clinical trial, which witnessed improvements in 2 cohorts subjected to spinal manipulation with or without orthotics. The latter, however, lacked an assessment between the groups. 8 There have been no studies involving the use of muscle testing in combination with foot orthotics to test the hypothesis that muscle activity appears to change with the use of shoe inserts 2 and to evaluate MMT to serve as an accurate transcript of neural dysfunction. 47,48 Our hypotheses were as follows:

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Primary hypothesis The orthotics group will show greater improvement than the sham group in the Quadruple Numerical Pain Rating Scale (NRS), the Roland-Morris Questionnaire (RMS), number of spinal fixations (FIX), and number of muscles graded below 5 (WkMus) at the last treatment compared with baseline.

Secondary Hypothesis The above outcome measures will be closely correlated as demonstrated in linear regressions. Therefore, the purpose of this study was to investigate the effects of 4 weeks of custom foot orthotics on pain, disability, recurrence of spinal fixation, and muscle dysfunction in adult chronic LBP patients receiving limited chiropractic care.

METHODS All phases of the proposed trial were conducted in the Research Laboratory of the Logan College of Chiropractic in Chesterfield, MO. The Logan College Institutional Review Board approved this trial, with all patients signing written informed consent forms before entry into the study. The registration number and simplified protocol of the trial are listed at www.clinialtrials.gov (NCT01704807).

Trial Design This was a double-blind, placebo-controlled parallelgroup study with balanced randomization conducted at the research facility of a chiropractic college in the Midwestern United States.

Patient Recruitment Patients were recruited with the incentive of providing free orthotics through advertisements in the local and municipal newspapers in nearby areas. Recruitment began August 1, 2011 and ended February 15, 2012. Upon review of their medical histories, patients were included according to the following criteria: current low back episode present 1 month or more, no change in the past month in prescription medications affecting musculoskeletal pain, being able to speak and understand English adequately to complete study forms, score on the RMS of 7.5 or higher, or average score on the Quadruple NRS (now, average, best, and worst scales from the Quadruple NRS) of 4 or higher. Exclusion criteria included use of foot orthotics within the past 12 months; previous lumbar spine surgery; self-reported ongoing LBP treatment by health care providers other than stable prescription medications affecting musculoskeletal pain; clinical significant chronic inflammatory spinal arthritis; severe osteoporosis, for

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which spinal manipulation is contraindicated; spinal pathology or fracture; progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome; history of bleeding disorder; known arterial aneurysm; self-reported pending/current litigation pertaining to back pain, including workers compensation claims; current pregnancy; lack of means of contacting (telephone number, stable address), which might preclude successful completion of study requirements; and inability to speak, read, or understand English, affecting the capability of a patient in the informed consent process.

Screening and Randomization According to the protocol outlined in Figure 1, entry into the investigation began with a telephone screening of interested applicants according to the criteria listed above. Individuals who appeared to qualify came to the study site and verified absence of exclusion criteria. Those not excluded were introduced to the study design and requirements by reading and signing the informed consent statement. Qualifying participants were given the RolandMorris and NRS questionnaires. If at least 1 score was high enough, the subject was included. If both scores were below the inclusion criteria, the subject was thanked and excluded. Included subjects completed a health history questionnaire and were assigned the next sequential subject number with their first baseline measurements marked as visit B1. Patients were randomized by means of random number generation from Excel 2007, odd numbers being assigned to group A and even numbers to group B. Subject numbers were assigned to subjects in order as they arrived. Only the research assistant knew the group assignment. A total of 24 subjects entered group A with 19 completing the trial, whereas 22 participants entered group B with 19 completing the trial (Fig 2).

Procedure The research assistant scanned the subjects' feet on the Foot Levelers Associate digital scanner device (FootLevelers, Inc, Roanoke, VA). The group assignment was included with the patient data sent electronically to Foot Levelers for the manufacture of inserts. Subjects in group A received custom fitted orthotics, whereas those in Group B received a flat insole as a sham, roughly approximating the orthotic in appearance without corrective configurations. Neither group was told which orthotic they had been assigned, only that they would receive 1 of 2 styles of orthotic. The custom and sham orthotics are illustrated in Figure 3A and B. The treating doctor of chiropractic was certified in AK. She reviewed the health history with the patient and verified that there was no medical contraindication to the subject's participation. The following muscles were tested bilaterally:

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Fig 1. Allocation of study participants. (Color version of figure is available online.)

gluteus maximus, popliteus, lower trapezius, middle deltoid, and neck extensors. Then the entire spine was palpated and challenged for spinal fixations according to AK protocols. 46,64 This first battery of outcome measurements included a health history questionnaire, NRS and Roland-Morris scores, manual muscle tests, and spinal analysis (B1 in Fig 2.) No treatment was administered at the first examination visit. Patients were sent home and scheduled to return in approximately 2 weeks. The starting point used to calculate the mean duration of pain was estimated from the medical history by the following criteria: (a) If the month was given, used the 15th; (b) if the year was given, used July 1; (c) if “years” was stated, used September 15, 2008 (3 years prior); and (d) if “so long I can't remember,” used 10 years before B1. Upon return for the delivery visit (B2), each subject was reevaluated in the second battery of outcome measurements (Fig 2). Patients then had the orthotic devices inserted into their shoes with the help of the research assistant and were asked to wear these for the duration of the study, gradually building up to full-day wear whenever possible. For the purposes of blinding, all patients were instructed not to discuss their orthotics with the treating doctor, patients, or other project personnel other than the research assistant, nor

to show their orthotics to anyone for the duration of the study. Then the treating doctor of chiropractic tested the same series of 5 muscles bilaterally and performed a spinal evaluation for fixations. She administered high-velocity, low-amplitude (HVLA) manipulations of the spine at locations found to be dysfunctional by means of vertebral challenge and palpation by the practitioner. If HVLA was contraindicated by the patient's condition at that visit, the doctor substituted a low-force method of manipulation, such as respiratory pumping or use of the Activator instrument. Levels manipulated and the method used were recorded on the patient's treatment form. After the manipulation, the doctor retested the muscles and rechallenged the spine for fixations. If patients had difficulty adjusting to the orthotics, they were encouraged to contact the research assistant for troubleshooting and/or advice. If after repeated efforts by the research assistant to troubleshoot the problem was not resolved, patients could reduce the time or discontinue altogether the use of the orthotic but were encouraged to continue their scheduled treatment visits at Logan for the duration of the study. Study participants returned 2 to 5 days later (F1). Questionnaires were administered before each follow-up

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Fig 2. Overview of study design. All time points are indicated: B1 and B2 baselines and follow-up times of F1, F2, F3, and F4 before (pre) and after (post) spinal manipulations at each visit, as shown. (Color version of figure is available online.)

treatment. Muscles were tested before and after each treatment session. They were treated as described above. The same process of treatment and evaluation was repeated approximately weekly at F2; F3; and, finally, F4 for a total of 5 adjustments (Fig 2).

Outcome Measures Number of Weak Muscles. All muscles were tested from a starting contracted position as described by Kendall et al, 65 Daniels and Worthingham, 66 Goodheart, 45 and Walther. 46 The starting position is designed to place the prime mover into the greatest advantage for the testing activity, keeping the synergist muscles at the greatest possible disadvantage. Pressure was applied toward lengthening; if the subject maintained the starting position against gradually increasing pressure from the examiner for the duration of the test, the muscle was graded as “strong,” corresponding roughly to a grade 5 of 5. 67 If the muscle failed to hold the starting position and broke away, the muscle was rated as “weak” corresponding to a grade of less than 5. Number of Spinal Fixations. Segmental motion of the spine was assessed by 2-vector challenge and the determination of fixations with palpation, as described by Goodheart 45 and Walther, 46 as distinguished from the assessment of

vertebral joint alignment and pliability originally described by Gillet 68,69 and Faye and Schafer. 70 The use of a single clinician, typically done in chiropractic practice, to determine this outcome was deemed acceptable by the fact that intraexaminer reliability of doctors of chiropractic to manipulate a particular lesion in patients with chronic LBP was found to be moderate. 71 Roland-Morris Disability Index. This validated 24-question selfreport instrument for lower back pain and disability has been in wide use since its introduction in 1976. 72 Quadruple NRS: NRS Now, NRS Ave, NRS Worst, NRS Best. The Quadruple NRS uses 4 intensity scores (current, average, worst, and best pain) from the NRS (related to the visual analog scale [VAS]), 71,72 an established self-report measure consisting of a line on paper with verbal anchors “no pain” and “worst possible pain” labeling each end and equally spaced numbers 0 to 10 along the line. 73 The scale was applied for back pain only.

Interventions Chiropractic Manipulation. This intervention is the principal modality used by most doctors of chiropractic, 74 a brisk thrust away from the greatest restrictions as described above. In this case, counterrotational thrusts were applied to 2 contiguous

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sole recorded by a photographic scanner (Associate; Foot Levelers, Inc, Roanoke, VA). The subject gradually increased wear over a break-in period of a week, with the goal of wearing the orthotic or sham most of the time every day. All scans were retained by Foot Levelers until the termination of the study, at which time the group receiving sham orthotics was offered the opportunity to receive a pair of custom orthotics based upon the original scan.

Duration of Treatment Planned duration of treatment was 22 to 24 days (5 visits over the course of 4 weeks). As treatment was only available on Mondays and Wednesdays, minor variations from the planned schedule happened due to some subjects' time constraints. Actual mean duration of treatment for each group was 22 days, group A ranging from 14 to 31 days and group B spanning 19 to 28 days. The examining/treating doctor remained blinded to the patient's group assignment throughout the study. The first patient entered the protocol on September 7, 2011, with the final participant completing the trial on March 14, 2012. At the final visit, subjects and the treating doctor completed an exit survey.

Dropouts Forty-six subjects started the study. Thirty-eight completed all 5 visits, and 2 in group A and 1 in group B completed 4 visits and supplied exit survey data. The data from the fourth treatment visit were treated as final data in these 3 cases for a total of 41 subjects included in the data analysis. At least 3 attempts were made to contact patients who left the study prematurely, in order to capture missing data at the time of their departure. 75-78 Fig 3. Orthotic and sham devices used in the study: custom orthotic, group A (A), and sham flat insole, group B (B). (Color version of figure is available online.)

fixated segments, according to challenge and the restrictions found on palpation, according to AK protocol. 47,48 The alternate manipulation methods used, if the patient's condition on a particular visit was a contraindication to HVLA, were either respiratory adjusting—in which the vertebral segment(s) to be treated was/were firmly pressed in the direction, which produced weakness on vertebral challenge during the phase of respiration, which cancelled the weakness from the challenge—or use of the Activator adjusting instrument. Only 2 subjects were treated exclusively with low force techniques. One was treated with a combination of HVLA and the Activator instrument. All those requiring low force were in group A. Foot Orthotics. A full-foot custom orthotic or sham insole was fabricated by Foot Levelers, the custom orthotic based on the size and standing pressure distribution pattern on the

Test of Blinding At the conclusion of the study, the treating doctor of chiropractic was asked to record which of the 2 groups she believed each patient was assigned to. Patients were asked whether they thought that their orthotics were customized to their foot and also (a) how much of their waking time they wore their inserts, (b) whether they found them helpful, and (c) whether they had any difficulty using them. The clinician reported having no idea on which of the 2 inserts the patient was using for all but 2 subjects, guessing correctly once and incorrectly once. Eighty percent of the subjects with custom orthotics believed that the inserts were actually corrective, whereas 65% of the participants in group B thought the same.

Statistical Analysis Sample size estimates indicated that a sample of 20 subjects in each group would have a power of 80% to detect a difference of 1.3 (yielding an expected SD of 1.4) on a

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Table 1. Analysis of variance group × time determinations of within-group comparisons of outcome measures Outcome

Group × time interaction SD of differences Difference B2-B1

NRS Now NRS Ave NRS Best NRS Worst RMS WKMUS FIX

.46 .84 .99 .83 .76 .96 .49

8.29 6.58 6.42 6.27 15.6 5.2 3.82

− 0.27 (− 0.98, 0.44) 0.61 (− 0.62, 1.85) 0.67 (− 0.54, 1.88) 0.01 (− 1.16, 1.18) 0.32 (− 2.6, 3.2) 0.32 (− 0.67, 1.30) − 0.27 (− 0.98, 0.45)

Tukey P value Difference F4-B1 .89 .71 .60 .99 .99 .94 .89

− 1.13 (− 1.84, − 0.42) − 1.47 (− 2.7, − 0.22) − 1.13 (− 2.33, 0.08) − 0.96 (− 2.13, 0.21) − 3.28 (− 6.2, − 0.37) − 1.47 (− 2.45, − 0.49) − 0.86 (− 1.57, − 0.15)

Tukey P value Difference F4-B2 .0001 .01 .083 .18 .017 .0004 .008

− 0.86 (− 1.57, − 0.15) − 0.85 (− 2.09, 0.39) − 0.46 (− 1.67, 0.75) − 0.95 (− 2.12, 0.22) − 2.96 (− 5.88, − 0.05) − 1.15 (− 2.13, − 0.17) − 1.13 (− 1.84, − 0.42)

Tukey P value .008 .36 .88 .19 .044 .011 .0001

FIX, number of spinal fixations; NRS, quadruple numerical pain rating scale; RMS, Roland-Morris questionnaire; SD, standard deviation; WKMUS, number of muscles graded below 5.

single NRS scale with α = .05, whereas group sizes of 17 should detect a difference of 2.5 (yielding an expected SD of 2.5) on the RMS. 79 We thus set the target size of each of the 2 groups at 23 to allow for dropouts during the course of the trial. Descriptive statistics were compiled on patient characteristics at the baseline before treatment for each cohort to assess comparability of groups, using an independent-sample t test. 80 To assess the impact of treatment on both groups and to determine if the impact differed between the 2 groups, we ran a repeated-measures analysis of variance with a group × time interaction. A nonsignificant interaction would suggest that the level of improvement was not different between the groups. In addition, we tested three 2-way comparisons after adjusting for multiple comparisons with the Tukey correction to protect the experimentwise error rate. Specifically, we tested the 2 baseline time points (B1 and B2) and the final time point against the baseline (F4 vs B1, F4 vs B2). The results of these tests are shown in Table 1 and Figure 4. Proc GLM in SAS was used to conduct these tests. Correlations of outcomes by means of linear regressions were conducted as well. SAS version 9.3 (Cary, NC) was used for all analyses, and a 2-tailed P value of .05 was used to determine statistical significance.

RESULTS Recruitment Eighty-five patients were interviewed by telephone; 11 were excluded by the telephone questionnaire. Five patients were excluded by the questionnaire at the intake visit, including 2 who had used orthotics within the past year, 1 due to insufficient severity of pain, and 2 for no recorded reason, likely scheduling. An additional 23 who qualified after the telephone interview did not appear for the first intake visit (B1), cancelled, or never made an appointment. During the course of the trial, 5 dropped out at 3 visits or less and were not included in the results. Data from the 3 patients who dropped out after 4 visits were included, whereas a total of 38 patients completed the entire protocol of 5 visits. Attempts were made to contact all dropouts several times. Scheduling issues were the primary reason for early

departure. One patient believed that the orthotic (actually the placebo insole) was too tight in the shoes. One dropped out after the fourth visit due to an unrelated illness. The entire sequence of patient participation is summarized in Figure 1.

Demographics, Blinding, and Compliance Baseline characteristics in terms of sex, age, and duration of pain did not differ between groups significantly (data not shown). Twenty-one females and 25 males entered the study, their ages averaging 59.5 years (28-74 years). Patient compliance with wearing the orthotics or sham insoles was also not significantly different between the groups A and B. A substantial majority of participants in both groups believed that they had been issued custom orthotics (16/20 in group A, 13/20 in group B), suggesting successful patient blinding. The mean duration of the treatment period was 22 days for group A and 23 days for group B.

Outcomes No adverse events other than transient discomfort from some of the orthotics were experienced at any time during this study. Within-Group Comparisons. As shown in Table 1, the 2 baselines were not statistically different from each other for any measure in either group. By the final time point at F4, both groups improved significantly on all outcome measures, as shown by the B1 baseline except for VAS Best and VAS Worst. The same was apparent using the B2 baseline value, except that VAS Ave also displayed a nonsignificant change. These changes are also displayed in Figure 4. The clinically significant differential values of 1.5 for the NRS scale and 2.5 for RMS recently suggested in an international consensus 79 were attained within 3 to 4 weeks of treatment for both groups. No clinically significant value has been suggested for WkMus or FIX to date in the literature. Between-Group Comparisons. None of the outcome measures registered statistical difference between groups at any time point, as all interactions were nonsignificant. Correlations of Outcome Measures. To assess the concordances and covariances of all outcome benchmarks at each

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Fig 4. Within-group comparisons of outcome measures. Percent change in outcome measures during trial from first visit (N) to fourth treatment (F4) is indicated. Error bars represent 95% confidence intervals: NRS Now (A), NRS Ave (B), NRS Best (C), NRS Worst (D), RMS (E), WkMus (F), FIX (G). FIX, number of spinal fixations; NRS, quadruple numerical pain rating scale; RMS, Roland-Morris questionnaire; WKMUS, number of muscles graded below 5.

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measurement, linear regression equations and correlation coefficients were determined for NRS, RMS, WkMus, and FIX compared against each other. The equations and correlation coefficients displayed an overall average correlation coefficient of 0.82, ranging from 0.54 to 0.99, suggesting a very high degree of covariance. In addition, the results from our random slope hierarchical model showed that there was a significant association among all outcome variables, with the exception of WkMus and NRS Worst (all P b .05, data not shown). Subgroup Analysis: Amount of Time Orthotics Were Worn. To assess whether the portion of each day the orthotics or sham insoles were worn affected any of the outcome measures, the outcomes of the participants were divided into subgroups based upon the fraction of each day the devices were worn according to self-reports on the exit survey. In each group, subgroups a and b wore their devices for ½ each day or less during the trial, whereas subgroups c and d used their devices for more than ½ day. Although compliances between the subgroups a and b vs c and d were the same (unpaired t test, data not shown), preliminary betweengroup comparisons suggested that more robust changes in NRS Now, NRS Best, and WkMus at F3 for WkMus and FIX at the final visit at F4 occurred in subgroups c and d. (Table 2). However, the significance of these changes was not apparent once the differing baseline status of each of the groups was accounted for. The subgroup × time interaction was nonsignificant for all outcome measures, although severely underpowered (data not shown). Group A subjects who did not tolerate the orthotics well also tended to have more severe pain and more limited function at baseline. This is demonstrated in Figure 5, in which for all patients in group A wearing their orthotics for ½ day or less, all baseline scores are consistently higher than the corresponding values for the same participants who wore their devices for most of the day. In contrast, patients wearing the sham orthotics in group B displayed the opposite trend in baseline values comparing the shorter and longer periods of orthotic use each day. No statistically significant differences in any of the outcome change scores appeared between groups A and B in between-subgroup comparisons (data not shown); however, the study was underpowered to clearly demonstrate these differences.

Responses Immediately Following Treatments Immediately following each treatment, WkMus and FIX decreased markedly, as shown in Figure 6A and B. For example, at the time of the first treatment at B2, the decreases for WkMus were 75% and for FIX nearly 90%. At F4, these reductions were even greater (82% and 95% for WkMus and FIX, respectively). However, by the time of the next appointment, more than 75% of these decreases had been reversed. Differences between groups A and B were not significant (data not shown).

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Table 2. Amount of time orthotics were worn: between-group comparisons Outcome At F3 NRS Now NRS Ave NRS Best NRS Worst RMS WkMus FIX At F4 NRS Now NRS Ave NRS Best NRS Worst RMS WkMus FIX

Total (n = 21)

Subgroup a, b (n = 6)

Subgroup c, d (n = 15)

P

3.4 ± 2.5 4.5 ± 2.2 2.1 ± 1.8 7.4 ± 2.4 6.3 ± 5.2 1.8 ± 1.5 4.2 ± 1.2

5.2 ± 2.5 6.0 ± 1.7 3.3 ± 1.9 8.7 ± 1.0 7.7 ± 5.8 3.9 ± 1.3 5.0 ± 1.5

2.7 4.0 1.7 6.8 5.8 1.3 3.9

± 2.3 ± 2.2 ± 1.5 ± 2.6 ± 5.1 ± 1.3 ± 1.0

.038 a .057 .048 a .113 .472 .015 a .058

3.9 ± 2.5 4.5 ± 1.9 2.1 ± 1.6 7.5 ± 2.3 6.1 ± 4.8 1.6 ± 1.7 3.9 ± 1.2

4.8 ± 2.6 5.3 ± 1.8 3.2 ± 1.8 8.5 ± 1.4 8.7 ± 5.7 2.8 ± 2.3 4.8 ± 1.5

3.5 4.2 1.7 7.1 5.1 1.1 3.5

± 2.5 ± 1.9 ± 1.4 ± 2.5 ± 4.2 ± 1.0 ± 0.7

.281 .229 .056 .226 .131 .023 a .010 a

a, not worn daily; b, worm 0 to ½ day each day; c, worn ½ day to full day; d, worm full day. FIX, number of spinal fixations; NRS, quadruple numerical pain rating scale; RMS, Roland-Morris questionnaire; WkMus, number of muscles graded below 5. a P b .05.

DISCUSSION This is the first study of its kind to evaluate custom foot orthotics on pain, disability, recurrence of spinal fixation, and muscle dysfunction. From a statistical viewpoint, both the custom-fitted orthotics group A and the flat insole (sham) group B registered significant changes on most outcomes for most time comparisons. However, in terms of clinical significance regarding both the NRS and RMS outcome measures, the total number of meaningful changes was considerably lower. All outcome measures (NRS, RMS, WkMus, and FIX) displayed a high degree of correlation. The overall result was that the secondary hypothesis in this investigation was supported, but not the first. It has been reported that the threshold of clinically significant change is a difference of 1.5 or greater in the NRS or 30% in the RMS. 79,81 For average RMS values originating at approximately 9 in this study, that would represent a minimum of 2.7. From our data, the only changes meeting these particular criteria were (1) the differential RMS scores in both groups A and B from the first evaluation at B1 to their exit at F4 and the NRS Now and RMS change scores for group B only from the time of the first treatment visit (B2) to the conclusion at F4. Thus, for both groups overall, the clinical effectiveness of the custom-fitted orthotic in any outcome measure could not be definitively demonstrated. It is understood that the changes obtained from the spinal manipulation of both groups could have overshadowed the more subtle differences sought between groups A and B. The effects of manipulation when assessed singly were short lived (Fig 6A and B). The observed decreases in FIX

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Fig 5. Compliers vs noncompliers in wearing of custom orthotics: Y-axis represents values for each of 7 outcome measures at baseline and at 4 weeks (F4) shown on the X-axis: custom orthotics, group A (A), and sham orthotics, group B (B). # of wk MM, number of weak manual muscles tested; NRS, quadruple numerical pain rating scale; RMS, Roland-Morris questionnaire. (Color version of figure is available online.) and WkMus with each manipulation were erased more than 75% from the end of 1 visit to the start of the next at 2 time points (B2 and F4). In other words, the gains experienced with each treatment in terms of muscle and vertebral dysfunction decayed—yet over 5 treatments, there were small improvements overall. This finding demonstrated the very objective of our investigation, that is, that some of the loss of beneficial effects following each manipulation over time might be reduced by the use of custom orthotics. Although this finding was not supported, our underpowered subgroup analysis hinted at a difference in results between people who did and did not wear their orthotics most of the day. We were unable to demonstrate a statistical subgroup

difference because subgroups were not equivalent at baseline. Future studies should be designed to measure wearing time formally so that differences based upon compliance can be definitively evaluated in outcomes. When all patients are averaged together for each of the 7 outcome measures tracked from baseline to trial exit at F4, all such measures are closely linked in their covariance, their Spearman correlation coefficients averaging 0.82. This demonstrates that such parameters as WkMus and FIX covaried with NRS and RMS throughout the course of this trial. A degree of validation of WkMus determined by AK methods in this investigation could thus be proposed from these data because this particular number correlated closely

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Fig 6. Changes in numbers of weak muscles (A) or spinal fixations (B) before and after spinal manipulations. Y-axis represents values for the outcome measures shown in A and B before and after each spinal manipulation.

with the previously validated measures of the NRS 82 and RMS. 72 Interestingly, the correlation coefficients for several outcome measures, paired with WkMus and FIX, decreased noticeably when the custom orthotic rather than the sham was used (data not shown). Our investigation was prompted by the commonly observed link between foot imbalance and musculoskeletal disturbances, including LBP. The implication has been that foot imbalance leads to postural fatigue and spinal strain,

often leading to LBP. 83,84 Given the abundance of literature supporting the effectiveness of orthotics 8-39 as opposed to the statement in the 2009 Cochrane systematic review that “there is strong evidence that the use of insoles does not prevent back pain,” 85 it was deemed appropriate to assess the possible efficacy of orthotics in more subtle circumstances—such as prolonging and/or enhancing the effectiveness of spinal manipulation or in reducing the number of spinal fixations or muscles testing weak in AK by

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qualified examiners. Applied kinesiology was used as a means to identify spinal fixation, based upon (1) the presence of specifically bilaterally weak muscles, (2) a unique pattern of motion restriction leading to the manipulation of either adjacent vertebra to the fixated section in a counterrotational fashion, confirmed by (3) the vertebral challenge of a counterrotation in the segments to be manipulated. 45,46 The fact that muscle activity has been reported to change with the use of shoe inserts 2 likewise provided the rationale for considering AK as a test of muscle function. The chiropractic intervention was limited compared with what is commonly performed in actual practice 74 or compared with the standard of care recommended by the Council on Chiropractic Guidelines and Clinical Parameters. 86 Interventions involving the pelvis, cranium, and local muscles were excluded, which is likely to have limited the improvements in pain and disability observed. Also absent were such ancillary treatments as soft tissue therapies, hot packs, electrotherapy, or ultrasound. These in addition to an increased number of treatments of up to 12 apparently were associated with greater improvements in both pain and disability lasting for longer periods in other studies. 87 The fact that substantially greater decreases in both pain and disability are apparent within 1 month in chronic back patients visiting actual chiropractic offices 88 underscores the potential value of the full range of ancillary treatments and interactions with the practitioner in live practice as opposed to the more restricted clinical trials. The strength of this study lies in its successful blinding. The treating doctor of chiropractic was fully oblivious as to which class of orthotics her patients were wearing. Of the 2 subjects about whose blinding the doctor had suspicions, she guessed correctly just once. Patients, on the other hand, believed, in large numbers, that they were wearing the custom orthotics (80% in group A and 65% in group B), regardless of their assignment. While providing both a visual disguise and some cushioning, the sham device achieved its purpose in blinding but perhaps at the expense of providing enough therapeutic relief on its own so as to blur its distinction in outcome measures from the custom orthotic.

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2.

3.

4.

Limitations Several study limitations were identified, which could explain our apparent failure to support the primary hypothesis: 1. No quantitative or qualitative data were available from the scans of the feet taken to indicate whether groups A and B were equivalent in a number of parameters or foot dysfunctions, such as arthritis or pronation. The scanner was used with the protocol by which orthotics are routinely prescribed in clinical practice. Visual inspection of the scans indicated that

5.

most subjects in each group had clear pronation. Techniques have been described by others to assess foot pronation and other irregularities, 89,90 which could be used in future research. Furthermore, an assessment of the foot in 3 dimensions rather than the 2 provided by the Associate scanner is required if an orthotic, which is fully customized to the individual patient, is to be provided. Finally, patients may have volunteered for the investigation simply to acquire free orthotics, whether or not orthotics were clinically indicated. The amounts of weight-bearing time on the custom orthotics or flat insoles were not formally measured, such that more significant advantages of the orthotics group A could have been obscured. Future determinations with wearable wireless accelerometers to detect foot-ground contact time 91,92 could be means to account for and nullify this potentially confounding variable. The sham insoles did provide a degree of cushioning and possibly correction. To provide adequate blinding as to which orthotic patients received (verified in the trial with the polling of subjects), the shams had to be fabricated with a number of ridges and depressions and were not completely flat insoles—as shown in Figure 3. In fact, some patients were quite enthusiastic about how good their feet felt in their sham orthotics. Patient tolerance of the custom orthotics was problematic, with a third in group A and 20% of group B wearing their devices for a half day or less. Because of time constraints, only 1 week was allowed as a break-in period for the orthotics for all patients. Two weeks of break-in is more common in clinical practice. Differences in outcomes were suggested for the patients in group A, who wore their devices for the majority of time as opposed to those using their orthotics for ½ of each day or less (Figure 5). Group B subjects did not show any differences between those who wore their orthotics for more or less time. Breakin periods of orthotics were recently described by Burke and Papuga, 93 whose inclusion of NRS comfort ratings of the insoles would have been a useful addition to this study. The findings of Che et al 44 and Hume et al 94 are critical in this regard, in that foot sensitivity 44 and freedom from fatigue and even injury 94 have been intimately associated with perceived comfort. Further studies will need to assess patient comfort with scales that are possibly more sensitive than the NRS scale—although a previous study using the 100-mm VAS was capable of detecting significant differences in comfort among 4 prefabricated foot orthotic devices. 95 A more usual clinical approach to treating patients who actually needed orthotics would be to adjust the feet and, in AK, to balance the muscles in the vicinity

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of the feet and ankles. Including these procedures might have produced a greater effect from the orthotics and improved tolerance. 6. Patients in the trial were seen to misinterpret the NRS and RMS questionnaires on occasion, failing to answer for the most recent period or neglecting to distinguish between the pain intensity and how much the LBP bothered them. Although 4 dimensions (Now, Average, Worst, and Best) of the NRS were included, patients sometimes would describe to their examiner how much better they felt while their questionnaires were unchanged. The patients may have failed to grasp the actual meaning of each of these facets of the questionnaires; may have attempted to please the treating doctor of chiropractic; or may have been verbally reporting an aspect of improvement that the questionnaires did not capture. What might be preferable in future studies would be to use separate direct measurements of bothersomeness, as has been done elsewhere in back pain studies. 96 7. Participants who responded to recruitment through newspapers were of middle to advanced age (all but one in the age range 41-83 years), may not be representative of the general population, and may be slower to respond to foot corrections than younger subjects. 8. The duration of the trial capped at 37 days (most 28 days or less) may have been too short for the effects of orthotic devices to have become fully established, creating a type II error. The peak beneficial effects of the orthotics used by Cambron et al, 12 by comparison, were observed after 42 days of use—in which NRS Now and RMS changes averaged 2.2 and 3.8, respectively, compared with the corresponding values of 0.7 and 1.9 observed in our study. It is possible that the custom orthotics induced biomechanical changes in the spine, which had not yet been fully integrated by the body by the end of the study period, whereas the simple cushioning provided by the shams protected against shock without changing alignment, such that its effect was evident in a relatively short period. The duration of our study was limited by the trimester calendar of the university where the study was conducted. 9. The RMS has been open to criticisms regarding its validity: a. For patients with persistent back pain, both the RMS and numerical rating scales have been deemed “largely inadequate” in a study involving 36 working adults who had previously sought primary care for back pain. 97 b. Increasing time intervals between readings, such as found in our study, have been shown to reduce agreements of RMS measurements in test-retest situations with limits of agreement shifting

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noticeably within 1 to 4 weeks, consistent with the duration of our investigation. 98 c. Differences in the responsiveness of the RMS have been identified when using such different external criteria as (1) global perceived effect of change in complaints, (2) global perceived effect of change in ability to take care of oneself, or (3) change of rating of pain intensity. 99 d. The RMS was found to be less responsive as a patient-specific outcome measure than either the Oswestry Disability Index or Patient Specific Activity Questionnaire with individuals with either mild to moderate subacute and chronic LBP. 100 For detecting changes in patients with low level activity limitation—such as that found in our study —the RMS was shown to be less responsive than the Patient-Specific Functional Scale. 101 In summary of the limitations, sources of potential bias, citing the aforementioned limitations, included differing degrees of pronation (1), weight bearing (2), and tolerance (4) between groups. Imprecision of measurement was reflected by the 2- rather than 3-dimensional evaluations of the foot afforded by the Associate (1), misinterpretation of the NRS (6), limited duration of the trial (8), and limitations of the RMS (9). Generalizability of results could have been restricted by the demographics of the actual trial participants (8). Other researchers' findings that inhibitions of muscles suspected to have a stabilization role are common in patients with spinal complaints 60-63 were supported by our observations. That such inhibitions resolved in substantial numbers through the course of this investigation following spinal manipulation supports the original concepts of AK 45,46 in that MMTs serve as useful diagnostic tools both upon initial presentation for immediate feedback during each treatment visit and subsequently as they reflect changes in the widely used outcome measures in pain and disability in instances of back pain.

CONCLUSION In a randomized controlled trial of 46 adults with back pain of greater than or equal to 1 month's duration, withingroup comparisons of patients wearing custom shoe orthotics or flat insoles produced significant improvements in most outcome measures except NRS Best and NRS Worst but failed to demonstrate differences between groups A and B. All outcome measures displayed a high degree of covariance, especially when sham orthotics were used. Between-group comparisons revealed no significant differences in any outcome measure at any time point, possibly attributable to the improvements of the outcome measures produced by the spinal manipulation administered and/or limitations of the study itself. Possible trends toward

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greater improvements were observed, with custom and not sham orthotics worn consistently; however, these were not statistically significant.

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Critical review (revised manuscript for intellectual content, this does not relate to spelling and grammar checking): AR.

REFERENCES Practical Applications • The addition of shoe inserts (sham or customized) produced significant improvements in disability and several measures of pain as well as reductions of spinal fixations and the numbers of weak muscles tested by an applied kinesiologist. • However, differences between sham or customized shoe inserts could not be demonstrated in the groups compared. • All outcome measures (Quadruple NRS, RMS, WkMus, and FIX) display a high degree of correlation.

ACKNOWLEDGMENT The authors thank Kevin Kennedy for providing the statistical analyses and figures and Dr Rodger Tepe, Dean of Research and Development at the Logan College of Chiropractic, for consultations on the design and statistics. The support of Tyler Nelson and Kevin Storm as research assistants and Lynda Harris for conducting the telephone interviews and scheduling is gratefully acknowledged.

FUNDING SOURCES AND POTENTIAL CONFLICTS OF INTEREST Foot Levelers, Inc, was the funding source and provided scanning device, custom, and sham orthotics.

CONTRIBUTORSHIP INFORMATION Concept development (provided idea for the research): AR, KC. Design (planned the methods to generate the results): AR, KC. Supervision (provided oversight, responsible for organization and implementation, writing of the manuscript): AR, KC. Data collection/processing (responsible for experiments, patient management, organization, or reporting data): AR, KC, TE. Analysis/interpretation (responsible for statistical analysis, evaluation, and presentation of the results): AR. Literature search (performed the literature search): AR. Writing (responsible for writing a substantive part of the manuscript): AR, KC.

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Influence of foot orthotics upon duration of effects of spinal manipulation in chronic back pain patients: a randomized clinical trial.

The purpose of this study was to investigate the effects of 4 weeks of custom foot orthotics on pain, disability, recurrence of spinal fixation, and m...
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