http://informahealthcare.com/dre ISSN 0963-8288 print/ISSN 1464-5165 online Disabil Rehabil, Early Online: 1–9 ! 2015 Informa UK Ltd. DOI: 10.3109/09638288.2015.1061609

RESEARCH PAPER

Health-related quality of life improvements among women with chronic pain: comparison of two multidisciplinary interventions Sigru´n Vala Bjo¨rnsdo´ttir1,2, Margre´t Arnljo´tsdo´ttir3, Gunnar To´masson2, Jan Triebel3,4, and Unnur Anna Valdimarsdo´ttir2,5 1

Department of Physical Therapy, and 2Centre of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavı´k, Iceland, 3HNLFI Rehabilitation Clinic, Hveragerôi, Iceland, 4Department of Orthopaedic Surgery, Akademiska, University Hospital Uppsala, Sweden, and 5 Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA Abstract

Keywords

Purpose: To measure the effect of 4 weeks traditional multidisciplinary pain management program (TMP) versus neuroscience education and mindfulness-based cognitive therapy (NEM) on quality of life (HRQL) among women with chronic pain. Method: This observational longitudinal cohort study conducted in an Icelandic rehabilitation centre included 122 women who received TMP, 90 receiving NEM, and 57 waiting list controls. Pain intensity (visual analogue scale) and HRQL (Icelandic Quality of Life scale) were measured before and after interventions. ANOVA and linear regression were used for comparisons. Results: Compared with controls we observed statistically significant changes in pain intensity (p50.001) and HRQL (p50.001) among women receiving both interventions, while NEM participants reported significant improvements in sleep (8.0 versus 4.4 in TMP; p ¼ 0.008). Head to head comparison between study groups revealed that pain intensity improved more among TMP participants (21.8 versus 17.2 mm; p ¼ 0.013 adjusted). Women with low HRQL at baseline improved more than those with higher HRQL (mean TMP ¼ 13.4; NEM ¼ 12.9 if HRQL  35 versus mean TMP ¼ 6.6 and NEM ¼ 7.8 if HQRL435). Conclusions: Our non-randomized study suggests that both NEM and TMP programs improve pain and HRQL among women with chronic pain. Sleep quality showed more improvements in NEM while pain intensity in TMP. Longer-term followups are needed to address whether improvements sustain.

Chronic pain, health-related quality of life, mindfulness, multidisciplinary rehabilitation, neuroscience patient education History Received 25 November 2014 Revised 18 May 2015 Accepted 9 June 2015 Published online 30 June 2015

ä Implications for Rehabilitation    

Chronic pain is a debilitating condition affecting quality of life and restricting societal participation. Intensive multidisciplinary bio-psycho-social rehabilitation is essential for this patient group. This study shows improvement in health-related quality of life and pain intensity following such rehabilitation. Emphasizing mindfulness based cognitive therapy and neuroscience patient education improves sleep to more extend than more traditional approach.

Introduction Musculoskeletal chronic pain is a common public health threat across populations affecting quality of life [1] and societal participation [2]. Recent studies show reported point prevalence of chronic pain to vary from approximately 20–37% in the general population [3–9]. This variation may depend on the methodology used, definition of chronic pain conditions and conditions or

Address for correspondence: Sigru´n Vala Bjo¨rnsdo´ttir, Department of Physical Therapy, University of Iceland, Stapi v/Hringbraut, 101 Reykjavik, Iceland. Tel: +354 5254091. Fax: +354 5254008. E-mail: [email protected]

diseases included in the studies. Most of these studies report higher prevalence among women [4,5,8,9], with increased age [3–5,7–9] and poorer socio-economic status [3–5,9]. It is well recognized that chronic pain is a complex biological, psychological, social and existential phenomenon that requires a multidimensional treatment approach. Recent studies indicate that multidisciplinary bio-psycho-social rehabilitation for people with various chronic pain conditions may be efficacious [10–17], particularly when offered as a group therapy [12]. Although multidisciplinary programs vary, there is evidence that more intensive inpatient programs show better results [18,19]. Recently published systematic reviews on multidisciplinary programs for people with chronic pain [19], chronic low back pain [20] or

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fibromyalgia syndrome [21] agree on recommended content in such programs. This would include: general exercise, relaxation techniques, psychological group therapy, patient education related to neurophysiology, physiotherapy for pacing strategies and medical exercise therapy. Yet, there is lack of evidence for effectiveness of multidisciplinary treatment for neck and shoulder pain. Data are scarce on the effectiveness of varying multidisciplinary interventional approaches; some studies use waiting list controls [17,22] and/or compare with usual care [15,22,23] or compare different therapies with multidisciplinary treatment [15,24]. Results from these studies suggest that people with chronic pain improve quality of life following multidisciplinary intervention to a greater extent than those undergoing usual care or are on a waiting list. Results from one study further indicate that multidisciplinary intervention is more effective than treatment with behavior-oriented physical therapy or cognitive behavior therapy [15], while another shows no difference between multidisciplinary and mindfulness based intervention [24]. As patient care and treatment develop with new knowledge and research, caregivers are expected to and optimally do change their course of practice accordingly. However, changes can be costly; therefore professionals as well as governmental and institutional authorities need to ascertain that changes are beneficial. Hence, the purpose of this study was to assess the comparative effectiveness of two multidisciplinary bio-psycho-social rehabilitation interventions for chronic musculoskeletal pain; traditional multidisciplinary pain management program (TMP) that includes exercises, traditional back school and traditional relaxation techniques versus neuroscience patient education and mindfulness-based cognitive therapy (NEM), that includes neuroscience patient education with reference to behavioral patterns and catastrophic thought processes. We hypothesized that while both 4-week interventions would result in reduced pain intensity and improved health-related quality of life (HRQL) there would be a significantly greater improvement among participants receiving the NEM intervention.

Methods Study setting This study was conducted at HNLFI Rehabilitation Clinic in Iceland in 2001–2009. The rehabilitation clinic is an in-patient institution serving people nationwide in need of various rehabilitation services. At HNLFI the NEM intervention was introduced in 2006 with cessation of the previously offered TMP approach in order to incorporate mindfulness and neuroscience patienteducational approach. In this study, we thus compare potential improvements among three cohorts: NEM intervention participants receiving treatment from 2006 to 2009; TMP participants receiving treatment from 2001 to 2005 and reference cohort of subjects on waiting list for admission to that institution. All participants signed an informed consent prior to inclusion in the study. The study was approved by the Icelandic bioethics committee (approval no. 07-146-S1) and by the Icelandic Data Protection Authority (approval no. 2007120859). Participants Participants in this study were females with chronic pain [25] for at least 6 months, willing to participate in an in-patient group program for 1 month and abstain from other treatment modalities. Reference subjects were recruited from female individuals on a waiting list for an admission to the rehabilitation clinic in 2008. The eligibility criteria included any diagnosis related to chronic musculoskeletal condition and age

Disabil Rehabil, Early Online: 1–9

18–70 years. Every fifth eligible subject applying to the clinic was contacted by mail and received an information letter and invitation to participate. Intervention methods Treatments were led by a specialized inter-professional pain management team; physical therapists, a psychologist, a psychiatric nurse, a sport therapist, a rehabilitation physician, a medical massage therapist and access to a nutritionist for specific counselling. Other professionals participated in various group activities. All professionals were highly qualified and agreed on the proposed treatment approach. Coordination and adherence of professionals with proposed protocol was ensured through weekly meetings during intervention. Physical therapy sessions were primarily used for the purpose of assessment and consultancy on physical training optimizing the benefits of movement in terms of pain control and as treatment [26,27]. Emphasis was on patients’ strategies to overcome limitations and to work on fear avoidance behavior [28]. The sessions with the psychology professionals emphasized discussion on health promotion with respect to chronic pain and assisted patients in overcoming limitations in their daily lives. The physician took part in the initial assessment procedure, led weekly patient education and group discussion sessions and ensured any pharmacological adaptations needed. Although both intervention groups participated in body awareness sessions, the physical training for the TMP group emphasized traditional endurance, strength and flexibility training. In the NEM group there was put emphasis on motor control training in conjunction with neuroscience patient education and mindfulnessbased cognitive therapy (MBCT) [29]. Characteristics of the two interventional programs are described in Table 1 and detailed protocols are available upon request. Traditional back school versus neuroscience emphasized patient education The traditional back school of 12 sessions was based on lectures (see Appendix) and exercises. The exercises were aimed at enhancing proper body mechanics as well as strengthening and mobilizing/stabilizing the trunk. The content of the back school was similar to other programs described by researchers [30–32]. The neuroscience patient education [33] was incorporated in a program called ‘‘Health and activities’’ (see Appendix) with cessation of the former back school. Throughout the new educational program the knowledge was applied to behavioral patterns often accompanying chronic pain such as catastrophic thought processes and fear avoidance behavior. Relaxation versus mindfulness-based cognitive therapy The relaxation sessions used in the TMP intervention were led by nurses on call using modifications of the Jacobson’s progressive muscle relaxation technique known to be effective for stress management [34]. The MBCT approach used for the NEM intervention encompassed 2-h sessions twice a week during the 4week period. MBCT [29] was initially developed by integrating aspects of cognitive behavioural therapy [35] and mindfulness based stress reduction (MBSR) [36]. Although MBCT was developed as treatment for depression, both MBCT and MBSR have been used for people with chronic pain [37], a well-known comorbidity to depression [38]. Briefly, the MBCT program emphasizes that patients become aware of and relate differently to their own thoughts, emotions and bodily sensations. During the sessions, the patients acquire skills that allow them to disengage from their habitual dysfunctional ruminative thought patterns. Patients are trained to focus on acceptance and awareness in

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Table 1. Characteristics of the two multidisciplinary pain programs. TMP-GROUP

Physical activities Walking sessions (average time) Aqua gymnastics Exercises for neck and shoulder area Back school exercisesa Core exercisesb Tai Chi based body awareness training Individually based training (estimated time) Educational program Traditional back school educationa Health and activitiesc Group discussion sessions General lectures on health promotion Meditative and relaxing methods Traditional relaxation Morning relaxation Specialized relaxation due to pain Relaxation massage Relaxing mud bath Mindfulness based cognitive therapy Individual consults Medical doctor Physical therapist Psychologist/psychiatric nurse Estimated total time spent on active program

NEM-GROUP

Instructor

Number of sessions

Min/session

Instructor

Number of sessions

Min/session

ST ST ST PT

22 13 13 12

40 30 30 20

ST ST

22 13

40 30

PT PT

12 22

45 40

PT PT PT

13 12 22

45 45 40

PT

12

20

V V

4 12

60 45

PT (PP) V V

12 4 7

45 60 45

N N N MMT V

22 22 4 2 5

20 10 45 45 60

MMT V PP

2 5 8

45 60 120

2 5 2 100 h

30 45 60

2 5 2 101 h

30 45 30

TMP, traditional multidisciplinary pain management program; NEM, neuroscience patient education and mindfulness based cognitive therapy pain management program; ST, sports therapist; PT, physical therapist; V, various health care professionals; N, nurse; PP, psychologist/psychiatric nurse; MMT, medical massage therapist. a Each session (40 min) in the back school encompassed a lecture (20 min) and exercises (20 min), including body mechanics. b Back and abdominal exercises with special attention to the stabilizing system and motor control. c Lectures on neurobiology and neurophysiology of pain, and pain processing by the nervous system. Explain how the nervous system interprets information from tissues and modulates pain. Special discussion on peripheral sensitization, central sensitization and pain memory. Also behavioral patterns and catastrophizing thought processing.

the present. The MBCT program includes extensive homework for participants. Outcomes and follow-up All outcome measures were assessed at the beginning and by the end of the program (after 31 days). Participants were requested to fill-in the questionnaires and other forms and return to staff members that same night. Staff members offered assistance if needed. Reference subjects received two sets of questionnaires by mail and were instructed to fill-in one questionnaire promptly and mail back to the clinic, and repeat the process with the second questionnaire in 31 days. The following data elements were collected: pain intensity was assessed on a 100-mm visual analogue scale (VAS) [39–42]. HRQL was assessed with The Icelandic Quality of Life (IQL) scale [43], which is a generic measure of HRQL, consisting of 32 questions addressing 12 domains; general health, concentration, depression, social functioning, financial status, energy, anxiety, physical health, pain, self-control, sleep and general well-being. In addition, the instrument offers a summary score for HRQL. Psychometric properties and validity of the IQL in the Icelandic population have previously been described [44–46]. Added raw scores from the questions within each domain as well as the total summary score were transformed to standardized t-scores with a mean of 50 and standard deviation of 10. Thus, scores between 40 and 60 on each of the domains represent normal HRQL as the average person at the same age and gender within the Icelandic population. Lower scores always represent poorer HRQL with respect to the domain in question.

Information on employment status, sick leave, disability status and educational level was obtained through questionnaires. Information on number of diagnoses and analgesic medication was obtained through patient records at admission. Measurements of height (in cm) and weight (in kg) were also obtained from patient records and body mass index (BMI) calculated as height2/weight. Data analyses We used the G*Power software version 3.0.10 (Heinrich Heine Universita¨t Du¨sseldorf, Germany) for a priori power assessment for sample size estimation. We estimated to have a power of 80% to declare a difference between groups, estimating effect size of 0.25 at an alpha-level of 0.05, 53 participants per group were needed to adequately power the study. Analysis of variance (ANOVA) was used to assess differences in mean changes in pain intensity and HRQL scores between the study groups. To assess for violations to the assumption of variance homogeneity for all outcome measures, we calculated Fmax ratio; that is the ratio of the largest cell variance to the smallest. Since our sample sizes are considered relatively equal (the ratio between largest and smallest cell size in our sample is 2.1 and therefore within a ratio of 4–1 for largest to smallest cell size) we assumed homogeneity of variances if the ratio was less than 10 [47]. We used Tukey’s HSD (honestly significant difference) in post hoc comparisons for difference between the three groups [48]. Further, analyses on the summary scores for HRQL were stratified according to age (categorized as 50 years and younger or over 50 years), HRQL at baseline (categorized as

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35 points or less versus over 35 points), pain intensity at baseline (categorized as 66 mm and less on the VAS scale versus over 66 mm), working status (working or not working), BMI (categorized as less than 30 versus 30 kg/m2 and over), number of diagnosis (2 versus 3), and analgesic medication (using versus not using). To assess for potential differences in study outcomes between the TMP and NEM groups adjusted for potential confounders, we ran linear regression models adjusted for; age, the variable in question at baseline, medication use, number of diagnosis and employment status. Results are expressed as changes in mean scores for each outcome measure and p values of less than 0.05 were considered statistically significant. For statistical analyses the software SPSS statistics 20 (PASW statistics 20, SPSS Inc., Chicago, IL) was used.

Results Baseline characteristics Of 234 enrolled in the program, 212 women from 23 to 67 years old (mean ¼ 49.6 years) participated in the study, there of 122 received the TMP intervention and 90 the NEM intervention. The reference group included 57 female participants (Figure 1). Demographic characteristics of participants and baseline outcome measures are presented in Table 2. We found the data to be consistent with homogeneity of variances for all outcome variables. The Fmax ratios varied between 1.68 (the pain subscale of HRQL) and 5.39 (the depression subscale of HRQL).

and all domains of HRQL, except for financial status, among the women who received the TMP or NEM interventions compared with the reference subjects. There were no significant differences between the two interventions except for the sleep domain of the HRQL. Participants receiving NEM improved their sleep more than both the TMP group (8.0 versus 4.4; p ¼ 0.008) and the reference group (8.0 versus 1.5; p50.001). Head to head comparison of the NEM and TMP groups revealed that the NEM group improved more than the TMP group in terms of sleep [p ¼ 0.024 (adjusted); p ¼ 0.005 (unadjusted)]. There was more improvement among the TMP group participants than the NEM group in depression scores [10.0 versus 7.6 (p ¼ 0.043 unadjusted)] but the observed difference was nonsignificant after adjustment for potential confounders. The TMP group improved more than the NEM group with respect to decreased pain intensity [21.8 versus 17.2 mm (p ¼ 0.013 adjusted; p ¼ 0.105 unadjusted)] measured on a VAS scale. Subgroup analysis Women with low HRQL at baseline gained considerably more improvement (mean for TMP ¼ 13.4 and for NEM ¼ 12.9, for those with HRQL summary score  35 versus mean for TMP ¼ 6.6 and for NEM ¼ 7.8 for those with HQRL435) but the effect of the treatment interventions was neither modified nor by other factors tested (Table 4).

Discussion Effect of NEM and TMP interventions on pain intensity and HRQL at 1 month The effect of the two treatment interventions on the 12 domains of HRQL, HRQL summary score and pain intensity is summarized in Table 3. There was considerable improvement in pain intensity

Following 4-week intervention, women participating in a TMP, as well as in a newer approach, including neuroscience patient education and mindfulness-based cognitive therapy, show significant improvement in all aspects of HRQL (except financial status) measured on IQL and decrement in pain intensity, as compared to

Applicaons to the rehabilitaon centre, number not known

Every fih female applicant with musculoskeletal diagnosis during the year 2008 selected as reference subjects; n=93

Paents with chronic pain, registered for one month pain program; n=234

Paents with chronic pain, registered from Sept 2001-Nov 2005; n=134

Excluded, n=19; 2 quesonnaires were returned, 17 did not reply

Paents with chronic pain, registered from Feb 2006-Dec 2009; n=100

Eligible; n=74

Excluded, n=10; 6 did not show up for treatment, 4 were male parcipants

Excluded, n=4; 3 did not show up for treatment, 1 was a male parcipant

Eligible; n=124

Withdrawal, n=2; due to unrelated medical condions

Completed intervenon and included in analyses; n=122

Eligible; n=96

Withdrawal, n=6; due to unrelated medical condions

Completed intervenon and included in analyses; n=90

Figure 1. Study flow chart.

Incomplete quesonnaires, n=17; 15 did not answer both quesonnaires, 2 did not complete all necessary quesons

Completed quesonnaires, had pain and were included in analyses; n=57

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Table 2. Demographic characteristics of study participants and outcome measures before intervention. TMP-GROUP n ¼ 122

NEM-GROUP n ¼ 90

Reference group n ¼ 57

50.6 ± 7.2

54.7 ± 10.0

Demographic characteristics Age (years), mean ± SD 48.8 ± 9.2 Working status at admission Employed 69.7 On sick leave 17.2 Disablement 11.5 Unemployed 1.6 Not working for other reasons 0 Educational level Primary school education 14.8 College education 36.9 University education 14.8 Missing data on education 33.6 Body mass index (kg/m2), mean ± SD 30.6 ± 5.9 Number of diagnosis, median (IQR) 1.0 (1.0) Analgesic medication use Non-opioid 41.8 Opioid 18.9 Baseline measures on health-related quality of life and pain intensity General health (IQL-scale) 31.6 ± 8.5 Concentration (IQL-scale) 37.9 ± 10.8 Depression (IQL-scale) 38.0 ± 12.7 Social functioning (IQL-scale) 37.5 ± 11.0 Financial status (IQL-scale) 47.1 ± 9.7 Energy (IQL-scale) 35.6 ± 7.6 Anxiety (IQL-scale) 39.4 ± 11.0 Physical health (IQL-scale) 32.4 ± 8.4 Pain(IQL-scale) 34.3 ± 5.7 Self-control (IQL-scale) 38.4 ± 10.9 Sleep (IQL-scale) 38.0 ± 10.4 General well-being (IQL-scale) 36.0 ± 9.9 Quality of life (IQL-scale) 33.6 ± 9.5 VAS score (100-mm scale) 66.6 ± 14.9

71.1 21.1 6.7 0 1.1

Fmax ratios

66.7 17.5 8.8 3.5 3.5

17.8 35.6 20.0 26.7 30.7 ± 5.7 3.0 (2.0)

26.8 46.4 26.8 0 No data 2.0

30.0 20.0

43.9 17.5

33.8 ± 8.8 41.7 ± 9.8 43.7 ± 11.1 40.2 ± 10.8 48.1 ± 9.9 39.0 ± 8.0 43.2 ± 9.9 34.0 ± 8.7 32.1 ± 7.4 41.5 ± 10.4 38.6 ± 9.8 38.3 ± 9.7 37.0 ± 8.8 66.5 ± 15.2

36.4 ± 9.3 45.3 ± 9.3 42.8 ± 11.9 41.5 ± 10.7 48.4 ± 10.2 40.0 ± 9.9 41.5 ± 11.3 36.4 ± 10.1 34.9 ± 8.3 42.1 ± 10.2 41.5 ± 10.8 38.9 ± 10.5 38.3 ± 10.4 63.4 ± 20.7

3.94 3.38 5.39 3.65 2.70 1.94 3.48 2.64 1.68 2.48 2.56 2.74 4.50 3.69

Continuous variables are expressed as mean and standard deviations (SD) and categorical variables are expressed in percentages. TMP, traditional multidisciplinary pain management program; NEM, neuroscience education and mindfulness based cognitive therapy pain management program; Fmax, ratios calculated as the ratio of the largest cell variance to the smallest; IQL, Icelandic Quality of Life scale; VAS, visual analogue scale.

Table 3. Mean and standard deviation of change scores for all outcome variables of all three groups and significance of any between-group mean differences. Linear regression modelsa

General health (IQL-scale) Concentration (IQL-scale) Depression (IQL-scale) Social functioning (IQL-scale) Financial status (IQL-scale) Energy (IQL-scale) Anxiety (IQL-scale) Physical health (IQL-scale) Pain (IQL-scale) Self-control (IQL-scale) Sleep (IQL-scale) General well-being (IQL-scale) Quality of life (IQL-scale) VAS score (100-mm scale)

TMPGROUP

NEMGROUP

Reference group

TMP versus NEMcrude

TMP versus NEMadj

n ¼ 122 Mean ± SD

n ¼ 90 Mean ± SD

n ¼ 57 Mean ± SD

Overall ANOVA p Value

Between group comparisons

Beta

p Value

Beta

p Value

8.9 ± 8.0 8.0 ± 9.1 10.0 ± 9.2 7.6 ± 10.3 1.8 ± 6.3 11.3 ± 8.0 10.2 ± 9.6 8.9 ± 8.3 5.8 ± 6.8 8.0 ± 9.0 4.4 ± 8.8 10.7 ± 8.5 10.5 ± 7.7 21.8 ± 20.1

9.3 ± 8.4 5.8 ± 8.7 7.6 ± 7.9 7.0 ± 8.6 1.6 ± 5.3 9.7 ± 7.4 8.2 ± 7.5 8.4 ± 7.0 6.2 ± 8.9 7.7 ± 7.9 8.0 ± 9.6 9.8 ± 8.9 9.7 ± 7.0 17.2 ± 20.7

1.8 ± 4.2 0.5 ± 5.0 1.0 ± 4.0 0.5 ± 5.4 0.4 ± 3.8 0.5 ± 5.7 1.9 ± 5.1 2.0 ± 5.1 0.1 ± 6.8 0.7 ± 5.7 1.5 ± 6.0 0.9 ± 5.4 1.3 ± 3.6 0.6 ± 10.1

50.001 50.001 50.001 50.001 0.287 50.001 50.001 50.001 50.001 50.001 50.001 50.001 50.001 50.001

a, b a, b a, b a, b * a, b a, b a, b a, b a, b a, b, c a, b a, b a, b

0.474 2.165 2.450 0.634 0.169 1.569 2.065 0.436 0.380 0.239 3.569 0.924 0.760 0.461

0.676 0.083 0.043 0.636 0.837 0.147 0.092 0.686 0.724 0.840 0.005 0.446 0.463 0.105

1.041 0.248 0.528 0.303 0.135 0.203 0.556 0.011 1.023 1.471 2.801 0.153 0.406 0.711

0.370 0.827 0.588 0.803 0.875 0.848 0.597 0.992 0.333 0.166 0.024 0.895 0.696 0.013

Notes: TMP, traditional multidisciplinary pain management program; NEM, neuroscience education and mindfulness based cognitive therapy pain management program; IQL, Icelandic Quality of Life scale; VAS, visual analogue scale. a: p50.05 for TMP versus reference group; b: p50.05 for NEM versus reference group; c: p50.05 for TMP versus NEM. *Overall ANOVA test not significant and subgroup tests omitted. a Linear regression models: crude and adjusted for; age, the variable in question at baseline, medication use, number of diagnosis, and employment status

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Table 4. Change scores for health-related quality of life as a result of treatment comparing two interventions and a reference group, stratified by potential confounding factors measured at baseline.

TMP-GROUP

NEM-GROUP

Age (years) Less than 50 63 38 Mean ± SD 10.98 ± 8.06 10.46 ± 8.05 50 and over 59 52 Mean ± SD 9.97 ± 7.40 9.19 ± 6.21 Body mass index 530 kg/cm2 58 40 Mean ± SD 10.8 ± 6.7 9.3 ± 6.1 30 kg/cm2 64 50 Mean ± SD 10.2 ± 8.6 10.1 ± 7.8 Working status Working 85 64 Mean ± SD 10.5 ± 7.7 9.7 ± 6.9 Not working 37 26 Mean ± SD 10.5 ± 8.0 9.8 ± 7.6 Health-related quality of life (IQL) 35 70 34 Mean ± SD 13.4 ± 8.0 12.9 ± 8.0 435 52 56 Mean ± SD 6.6 ± 5.2 7.8 ± 5.6 Pain intensity (VAS) 66 mm 51 37 Mean ± SD 8.7 ± 7.3 9.0 ± 6.6 466 mm 71 53 Mean ± SD 11.8 ± 7.8 10.2 ± 7.3 Number of diagnosis 53 diagnosis 93 44 Mean ± SD 10.5 ± 8.1 9.8 ± 7.0 3 diagnosis 29 46 Mean ± SD 10.4 ± 6.5 9.6 ± 7.1 Non-opioid and/or opioid analgesic medication use at baseline Using 61 33 Mean ± SD 10.3 ± 7.6 8.0 ± 6.4 Not using 61 57 Mean ± SD 10.7 ± 7.9 10.7 ± 7.3

Reference group

Between group comparisons

16 3.25 ± 4.09 41 0.54 ± 3.19

a, b

No data

NS

No data

NS

37 1.2 ± 3.7 20 1.6 ± 3.5 21 2.6 ± 2.7 36 0.6 ± 3.9 29 1.0 ± 3.3 28 1.6 ± 4.0 23 2.0 ± 3.9 34 0.8 ± 3.5 26 1.7 ± 3.4 31 0.9 ± 3.5

a, b

a, b a, b a, b a, b a, b a, b a, b a, b a, b a, b

Values represent counts, mean and standard deviation (SD). a: p50.05 for TMP versus reference group; b: p50.05 for NEM versus reference group; NS: p40.05. TMP, traditional multidisciplinary pain management program; NEM, neuroscience education and mindfulness based cognitive therapy pain management program; IQL, Icelandic Quality of Life scale; VAS, visual analogue scale.

reference subjects. Thus our results support existing evidence that intensive multidisciplinary bio-psycho-social rehabilitation is effective for women who experience chronic pain conditions. An important finding is that participants in the NEM program showed significantly more improvement with respect to sleep disturbances than the TMP participants. The results further indicate that TMP participants improved more than NEM with respect to pain intensity when study groups were compared head to head. The knowledge on pain physiology has evolved considerably during the last two decades and it is now recognized that multiple factors and body systems contribute to the development and maintenance of chronic pain and psychological symptoms. This would include alterations in the nervous system such as cortical reorganization, dorsal horn ‘‘wind-up’’ and central sensitization, and changes to the hypothalamus–pituitary–adrenal axis as well as changes to the neuroendocrine system and immunological responses [49,50]. Our NEM approach included two new elements, namely more advanced neuroscience patient education and mindfulness training. Both elements target changes in the nervous system. Some unknown or unmeasured confounding factors might account for the differences in sleep improvement between treatment modalities. Thus, a randomized controlled trial

is needed to determine if either one of the two elements alone or this combination can be held responsible for the improvements in the sleep domain of HRQL superior to the TMP approach. Prior studies suggest that sleep disruption is a common complaint among people with chronic pain [51–54] and there is evidence that pain catastrophizing [55] and negative mood [56] may stimulate sleep disturbances in this patient population. While MBCT aims to train people in mindfully accepting their stressful experiences including pain, and change their relationship to the catastrophic thoughts, the neuroscience patient education aims to teach and explain the mechanisms involved. Recent clinical trials have shown that mindfulness based therapies are effective [57] and improve HRQL, including sleep disturbances [58,59] among people with chronic pain conditions. Further, some forms of neuroscience patient education have been shown to improve HRQL [60] and decrease catastrophic thought processes [33] in chronic pain populations. Compared with the control group both intervention groups reported diminished pain intensity on VAS, although the TMP group (change score ¼ 21.8) to greater extent than the NEM group (change score ¼ 17.2) when intervention groups were compared head to head. These changes are greater than were reported in a study of 4-week multidisciplinary back school

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DOI: 10.3109/09638288.2015.1061609

program where intervention resulted in a change score of 11 on VAS [61]. Neither TMP nor NEM program emphasized pain reduction as a result of the treatment but rather enhanced improvements in general health, quality of life, activities and participation. We have no explanation for the group difference observed in our study but there are controversies as to whether mindfulness based therapies are ineffective [62] or effective [63] with respect to pain intensity as an outcome measure. The multidimensional nature of chronic pain [64] may be an explanation by itself. Mindfulness therapies involve attention to bodily sensations, however, purposefully aim and result in improving the ability to regulate responses to pain [65]. It has further been shown that somatosensory attention is biased among people with chronic pain meaning that attention is directed towards painful areas [66]. Another important factor in mindfulness based therapies is focus towards acceptance, thus participants are trained to accept any experience, including pain. Another explanation might be that the NEM participants in our study had intensive 4 weeks of mindfulness training while courses in MBCT are generally dispersed over eight week periods. It is possible that optimum neurological changes [64] had not yet been reached with-in this timeframe and participants were still attending to the painful areas. More time of practice may be needed to show similar decrement in pain intensity as the TMP group. Both TMP and NEM emphasized lifestyle changes through active rehabilitation, counselling and patient education. The recommended physical activity levels for health benefits introduced by the World Health Organization were encouraged. Both mental and physical health benefits of physical activities are well documented and associations between recommended physical activity and HRQL have been reported for people with chronic conditions [67]. Non-smoking, healthy diet and weight control consultation was further administered as needed to encourage healthy living. It has been reported that positive changes in these factors together with adequate physical activity level are associated with decreased risk of chronic diseases [68]. It should be mentioned that when people apply for admission to the institution each application is reviewed by a professional team, including screening for psychological factors. At that stage further information may be required from the patient’s doctor or other healthcare professionals. If people have potentially severe psychological problems that can be dealt with to more extent by a specialized psychological team but also has chronic pain the applicant would be offered to choose between the two lines of treatment.

Limitations There are some limitations that need to be considered when interpreting the results. Participants in this study were not randomly assigned to the two intervention groups or the waiting list control group, and thus unmeasured confounders may affect the results. Further, results may be biased when using waiting list as a control. Although in this case all participants were at some point on a waiting list to enter the clinic. However, there should not be any cross-contamination since the two intervention groups were not treated at the same time even though they were treated in the same institution. Contamination can still be of concern with respect to similarities in the programs. The two programs share a number of elements that are similar and perhaps the two programs are too similar to show distinct differences. Although some male patients participated in the two programs, the number was insufficient for meaningful results and interpretation. Therefore, all the participants in the study were women and the generalizability is limited to women only. Quality of life and pain intensity are by nature subjective estimates on people’s well-being and are

7

self-reported. Since this study uses self-reported outcome measures some biases cannot be excluded. Potential biases would most likely be due to distorted recall and/or own perception. However, there is no reason to expect the participants across treatment modalities to change their answering style between the two measurement points. Further, the reference group received both sets of questionnaire at the same time but were asked to answer and mail one promptly and the other in 1 month. We cannot be sure that participants actually did wait 1 month to answer the second set, however, we did exclude two participants who returned the two sets at the same time.

Conclusions Health-related quality of life is an important measure for the understanding of perceived mental and physical health. The present study aimed at investigating the efficacy of multidisciplinary bio-psycho-social treatment options for chronic pain conditions, using HRQL as the primary outcome measure. The findings indicate that overall HRQL improves among women with chronic pain following 1 month of intensive treatment regardless of the primary emphasis in each program. Although the programs are similarly effective the NEM participants showed more improvement in sleep disturbances, whereas the TMP participants improved more with respect to pain intensity. Further studies are needed to confirm these findings on a long-term basis and to distinguish if one or both of the two new elements, that is the neuroscience patient education and the MBCT, contribute to these improvements. Future studies should further aim at effectiveness of modern multidisciplinary programs in terms of daily activities and participation in the societies and influences on environmental factors.

Acknowledgements We thank the HNLFI´ rehabilitation clinic for participation in the study and access to data. Special thanks to all team members in the pain department from 2001 to 2009 as well as patients enrolled in the two programs. We thank Professor Patty Solomon for assistance in preparing this manuscript.

Declaration of interest The authors report no declarations of interest. This study was granted by the Association of Icelandic Physical Therapists and from the Lifelong Learning Centre in Southern Iceland. The funding sources had no role in data acquisition, analysis or manuscript preparation.

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Appendix. Characteristics of specific educational programs for people with chronic pain

Traditional back school

Health and activities

Joints and joint prevention Anatomy, physiology and biomechanics of joints; structure and movement in various joints; optimal position during various tasks; joint related injuries and diseases; posture The spine; strengths and weaknesses Anatomy, physiology and biomechanics of the spine; spinal curves, posture and movements; posture and activities in relation to intradiscal pressure and joint forces; disc related injuries and diseases in the spine Sleeping problems Explaining normal sleep and disrupted sleep; various sleeping problems; resources due to sleeping problems Mental well-being and chronic pain Having chronic pain and be associated with those without; definitions of pain; own experience; mental well-being in relation to grief and reactions to grief; changes in health status and acceptance Importance of rest Importance of rest and sleep; various mattresses; posture of the spine on various mattresses; how to choose a bed; various resting positions; to choose an armchair Sitting postures Sitting postures; intradiscal loading; various positions

Joints and joint prevention Anatomy, physiology and biomechanics of joints; structure and movement in various joints; optimal position during various tasks; joint related injuries and diseases; posture The spine; strengths and weaknesses Anatomy, physiology and biomechanics of the spine; spinal curves, posture and movements; posture and activities in relation to intradiscal pressure and joint forces; disc related injuries and diseases in the spine Sleeping problems Explaining normal sleep and disrupted sleep; various sleeping problems; resources due to sleeping problems Mental well-being and chronic pain Having chronic pain and be associated with those without; definitions of pain; own experience; mental well-being in relation to grief and reactions to grief; changes in health status and acceptance Importance of rest Importance of rest and sleep; various mattresses; posture of the spine on various mattresses; how to choose a bed; various resting positions; to choose a armchair Sitting postures at work and at rest Sitting postures; intradiscal loading; various positions; working chairs; heights of chair and table; office design Lifting techniques Basic rules for lifting techniques; lifting loads; moving loads; lifting/ carrying with one hand/two hands; use of trolleys Movement control Basic motor learning; stabilizing versus motion musculature in the trunk and neck; special attention to the core muscles; structure and function Pain memory and movement Neurobiology and neurophysiology of pain, and pain processing; interpretation from tissues within the nervous system; pain modulation; central sensitization and pain memory; behavioural patterns and catastrophic thoughts Standing postures and ergonomics Dynamic posture; weight shift; how to apply weight shift to daily life and when appropriate; height of table during various activities; ergonomics Movement as stress management Definitions of stress; fight and flight reactions; movement as stress control; general benefits of exercising; effects of exercising on stress control, sleep, relaxation and mood; kind of training Goal setting and time management Goal setting; short term versus long term; ways to achieve goals; time management; problem solving

Lifting techniques Basic rules for lifting techniques; lifting loads; moving loads; lifting/ carrying with one hand/two hands; use of trolleys Muscles and blood flow Structure and function of different muscles; static versus dynamic muscle work; muscle pump and venous return Ergonomics – sedentary Working chairs; heights of chair and table; office design

Standing postures Dynamic posture; weight shift; how to apply weight shift to daily life and when appropriate Work in standing position Ergonomics due to standing and labour work; height of tables during various activities; reaching; squatting Pain and movement Physical versus mental influences of pain; role of endorphin and other chemicals on pain; kind of training, intensity and frequency