- Email: [email protected]
A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients
Patient Education and Counseling 98 (2015) 677–680
Contents lists available at ScienceDirect
Patient Education and Counseling journal homepage: www.elsevier.com/locate/pateducou
Short Communication
A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients Mimi Mehlsen a,*, Lea Heegaard b, Lisbeth Frostholm c a
Department of Psychology and Behavioural Sciences, Aarhus University, Denmark The Danish Committee for Health Education, Denmark c Research Clinic for Functional Disorders, Aarhus University Hospital, Denmark b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 9 September 2014 Received in revised form 7 January 2015 Accepted 10 January 2015
Objective: This study evaluates the feasibility and changes in pain, pain cognition, and distress during a patient education course and a 5-month follow-up period. The Chronic Pain Self-Management Programme (CPSMP) is a lay-led patient education consisting of six manualized sessions. Methods: A Danish adaptation of the CPSMP was tested in four municipalities. The sample consisted of 74 women and 13 men between 26 and 80 years with a long pain history (+10 years). Participants completed questionnaires before the CPSMP, immediately after and 5 months after the program. Results: The study showed that the Danish version of the CPSMP was feasible. The sample was heterogeneous with respect to age, education, duration and causes of pain but all participants reported serious pain and most experienced high levels of distress and disability. Participants evaluated the CPSMP as satisfying and more than 75% would recommend the program to other patients. Participants showed significant improvements on pain, disability, catastrophizing, depression, anxiety, and health worry, and changes were stable through the follow-up period. Conclusion: A consistent pattern of stable improvements in pain, pain cognition and distress was observed but the scope of changes was modest. Practice implications: The Danish version of the CPSMP is feasible. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Chronic pain Self-management Patient education Lay-led CPSMP
1. Background Chronic pain is pain which persists beyond normal tissue healing time, which is defined as 3 months [1]. The estimated prevalence of chronic pain in the European Union is 27% [2] with human costs such as a reduced quality of life [3], and an increased risk of developing common mental disorders [4]. Waiting lists for specialized pain clinics are often long with deterioration in health as an unacceptable consequence [5]. Therefore, low cost interventions have great individual and societal relevance. The Chronic Pain Self-Management Programme (CPSMP) is a patient education program targeting chronic pain patients [6]. The content of the CPSMP is similar to the Arthritis Self-Management Program, which has demonstrated efficacy in improving pain, selfefficacy, health behaviors and health care utilization in arthritis patients [7], but the CPSMP is adapted for various idiopathic
* Corresponding author at: Department of Psychology and Behavioural Sciences, Aarhus University, Denmark. Tel.: +45 87165874. E-mail address: [email protected] (M. Mehlsen). http://dx.doi.org/10.1016/j.pec.2015.01.008 0738-3991/ß 2015 Elsevier Ireland Ltd. All rights reserved.
chronic pain conditions [6]. The teaching methods used in the CPSMP are based on increasing participants’ self-efficacy, i.e. their belief in their own ability to set goals and implement behavioral changes, to reach their goals [8]. The program intends a high degree of participant involvement using the support of the group to strengthen participants’ self-efficacy. The program is not aimed at symptom-directed treatment of pain, rather the intention is to optimize pain management and to support rehabilitation and treatment processes [9]. In the first study on the effects of CPSMP in 110 participants with idiopathic pain, LeFort [6] found that participants reported less pain, less dependency on others, improved mental health, increased activity and satisfaction with their lives 3 months after end of treatment compared to a wait-list control. In the only other study of 256 older pain patients, improvements were found 6 and 12 months after a similar intervention, but there were no differences in effect when compared to patients receiving written material only [10]. In the present study we wished to examine the feasibility of a Danish version of the Canadian– American CPSMP measuring pre- to post intervention changes in relevant outcome measures.
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M. Mehlsen et al. / Patient Education and Counseling 98 (2015) 677–680
2. Methods
3. Results
2.1. Recruitment
3.1. Sample
Data for the present study was obtained from a pilot test in four municipalities of the adapted Danish version of the Chronic Pain Self-Management Program. Participants were eligible if they were 18+ years, spoke Danish, had pain lasting more than 3 months, rated their pain intensity >5 on a 10-point scale. Pain should not be caused by conditions of primary concern to the participant, e.g. cancer in acute stage or pregnancy, and participants with substance abuse, psychiatric or physical disease that would disturb participation in the course were excluded. Questionnaires were collected 2–14 days before the course started (T1), 1–3 weeks after the course (T2), and 5–6 months after the course started (T3).
One-hundred eligible citizens were included in the program. Of these, 87 answered the baseline questionnaire, 69 returned the first follow-up questionnaire immediately after the course and 73 the second follow-up questionnaire. The participants were 26 to 80 years old, had suffered from chronic pain between 0 and 45 years. More than one cause of pain was reported by 48% and 5% marked 4–5 causes of pain. The most frequent causes of pain were tear/ work injury, diseases, and accidents, 16% reported the cause of their chronic pain to be unknown (Table 1).
2.2. Procedure Participants were invited to participate in the CPSMP by local professionals in health care and social work. After receiving information about the evaluation, they completed the baseline questionnaire. The CPSMP consisted of six 2.5 h weekly workshops focusing on how to manage pain in daily life. Two trained workshop leaders facilitated the workshops in groups of 8–16 chronic pain patients. At least one of the workshop leaders suffered from a long term pain condition. After the last session, follow-up questionnaires were mailed to all participants with a postage prepaid envelope (T2 and T3). Written reminders were sent after 2 weeks and after 4 weeks participants were contacted by phone. 2.3. Questionnaires At baseline questions about socio-demographic parameters, pain duration and cause were answered. Pain was measured by the VAS and the Present Pain Intensity index from the McGill Pain Questionnaire [11]. Physical disability was measured by the 23-item Modified Roland-Morris Disability Questionnaire [12–14]. Pain catastrophizing was measured by the 13-item Pain Catastrophizing Scale [15]. Pain-related Self-efficacy was measured by a 5-item modified version of Arthritis Selfefficacy Scale [16]. The Common Mental Disorders Questionnaire [17] included four subscales assessing: depression, anxiety, physical symptoms, and illness worry. To evaluate the program, 13 questions were constructed regarding satisfaction, and relations to workshop leaders and other participants. 2.4. Statistical method Missing data in psychometric scales were handled at item level. If more than half the items on any given scale were completed, missing scores were replaced by the mean of the completed items [18]. Changes in pain, disability, catastrophizing, self-efficacy and distress were tested by repeated measures ANOVAs. A reliable change index (RCI) was calculated to evaluate statistical reliable change in each participant [19]. The RCI is a function of the standard deviation of the measure and its reliability: SE = SD1(H(1 rxx). When the applied reliability parameter (r) is a test–retest correlation based on data from a comparable sample, it introduces a historical control. For outcomes where test–retest coefficients were available, we calculated the RCI. Percentages of participants displaying reliable change were estimated. Clinical significance of change was evaluated by comparison with published cutoff values. Percentages exceeding clinical cutoffs before and after intervention were estimated.
Table 1 Sample characteristics at baseline. Variable
N
Age Mean (SD)
52.0 (12.4)
Gender Women Men
74 (85%) 13 (15%)
Living alone Marital status Not married Married/partner Divorced Widowed
31 (36%)
Children in household
25 (29%)
Education None/unskilled Skilled Short (<3 yrs) Medium (3–4 yrs) Long (+5 yrs)
14 16 26 26 5
(16%) (18%) (30%) (30%) (6%)
Job status Student Working Sick leave Sheltered employment Unemployed Pension Other
1 5 11 17 3 40 9
(1%) (6%) (13%) (20%) (3%) (46%) (10%)
Diagnoses Cancer Lung disease Cardiac disease Neurological disease Psychiatric disorder Arthritis Diabetes Neck-back disorder Musculoskeletal disorder Other
4 8 4 6 8 25 5 50 44 19
(5%) (9%) (5%) (7%) (9%) (29%) (6%) (58%) (51%) (22%)
Pain duration in years Mean (SD)
14 55 11 7
(16%) (63%) (13%) (8%)
9.9 (9.8)
Pain intensity VAS (SD) (mm) Likert 0–5 point
58.3 (16.3) 3.1 (0.7)
Daily pain medication None Over the counter (OTC) drugs Prescription drugs Both OTC and prescription
15 10 27 34
(17%) (12%) (31%) (39%)
Taking extra pain medication Seldom Several times weekly Daily Several times daily
27 37 10 7
(31%) (43%) (12%) (8%)
M. Mehlsen et al. / Patient Education and Counseling 98 (2015) 677–680
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Table 2 Changes in outcome parameters from baseline to follow-up. Measure
Physical disability (range 0–23) Pain VAS (range 0–100 mm) Pain intensity (range 0–5) Pain Catastrophizing (range 0–42) Pain-related Self-efficacy (range 5–50) Depression (range 0–6) Anxiety (range 0–4) Somatic symptoms (range 0–12) Health worry (range 0–7) * **
Baseline
T2
T3
N: 83–86
N: 65–68
N: 67–73
M (SD)
M (SD)
M (SD)
14.5 (4.5) 58.3 (16.3) 3.13 (0.72) 25.4 (9.6) 21.6 (8.5) 3.53 (1.73) 2.10 (1.73) 7.72 (2.77) 4.05 (2.37)
12.5 (4.9) 54.4 (19.0) 3.02 (0.87) 20.5 (9.4) 22.3 (9.0) 2.85 (1.73) 1.80 (1.31) 7.19 (3.02) 3.84 (2.11)
12.3 (5.5) 50.8 (19.3) 2.63 (0.91) 20.0 (10.5) 20.6 (10.0) 2.54 (1.81) 1.52 (1.36) 7.06 (2.82) 3.21 (2.30)
Wilks’ Lambda
Effect size d
0.708*** 0.831** 0.733*** 0.636*** 0.905* 0.760*** 0.835** 0.942 0.876*
1.28 0.90 1.21 1.51 0.65 1.12 0.89 0.50 0.75
p < 0.05. p < 0.01. p < 0.001.
***
3.2. Changes from baseline to follow-up
3.4. Clinical significance
The response rate at T2 was 79%. Compared to responders, nonresponders at T2 had reported significantly more disability at baseline (t = 2.487, p = 0.016) but non-respondents did not differ on any other outcome measure or sociodemographic characteristic. A series of repeated measures ANOVA’s revealed significant reductions in pain, physical disability, pain catastrophizing, symptoms of depression and anxiety, illness worry and physical symptoms from baseline to immediately after the CPSMP (see Table 2). At 5-months follow-up changes remained significant.
To evaluate the clinical significance of changes we estimated the number of participants who changed status from severe levels of pain and disability and from pathological levels of pain catastrophizing, depressive symptoms, anxiety, illness worry and physical symptoms, see Table 4.
3.3. Reliable change To examine changes at an individual level reliable change indices (RCI) was calculated for the outcome measures, see Table 3.
3.5. Participation and evaluation of the program On average participants attended 5 out 6 six sessions. Most participants were satisfied with the program (75%) and would recommend it to other pain patients (78%). But it should also be noted that a subgroup of about 10% of the responders gave poor ratings on most aspects, including experiences of instructors and the atmosphere at the sessions.
Table 3 Reliable change criteria and percentage reliably improved and deteriorated from Baseline to T2 and from Baseline to T3. Measure
Physical disability Pain VAS Pain intensity Pain catastrophizing Self-efficacy
SD
R or ICC
RCI scale-points
3.9 25.7 1.05 8.9 22.5
0.78 0.87 0.82 0.85 0.87
5.11 262 1.22 9.63 22.44
Baseline to T2a
Baseline to T3b
Improve
Decline
Improve
Decline
6 5 3 16 0
0 2 1 2 1
13 8 9 25 0
0 2 1 3 3
(7%) (6%) (3%) (18%)
(2%) (1%) (2%) (1%)
(15%) (9%) (10%) (29%)
(2%) (1%) (3%) (3%)
RCI calculated based on data from 1 Ostelo et al. (2004), 2 Adelmanesh et al. (2011), 3 Fernandes et al. (2012) and 4 Lorig et al. (1989). a Note: Percentages are calculated based on total baseline sample, T2 data was missing in 22–26% of participants. b Note: Percentages are calculated based on total baseline sample, T3 data was missing in 17–25% of participants.
Table 4 Participants scoring above clinical cutoff for pathological levels and distribution on different levels of pain severity. Measure
Clinical cutoff
Above cutoff at baseline
Above cutoff at T2
Above cutoff at T3
Pain catastrophizing Disability Depression Anxiety Somatic symptoms Health worry
301 14 (high level of dysfunction)2 3 (Depressive disorder)3 3 (Anxiety disorder)3 5 (Any somatoform disorder)3 3 (Any somatoform disorder)3
24 52 58 32 75 58
10 33 36 18 54 47
11 34 32 17 55 37
Pain VAS
No pain (0–4)4 Mild pain (5–44) Moderate pain (45–74) Severe pain (75–100)
0 19 (22%) 53 (61%) 11 (13%)
Cutoff values published in
1
Sullivan (2009),
2
Dunn and Croft (2005),
3
(28%) (60%) (67%) (37%) (86%) (67%)
Christensen et al. (2005) and
(12%) (38%) (41%) (21%) (62%) (54%)
0 18 (21%) 40 (46%) 7 (8%) 4
Hawker et al. (2011).
(13%) (39%) (37%) (20%) (63%) (43%)
0 24 (28%) 36 (41%) 7 (8%)
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M. Mehlsen et al. / Patient Education and Counseling 98 (2015) 677–680
4. Discussion and conclusion 4.1. Discussion In this prospective but uncontrolled study of the Danish CPSMP, we found significant reductions in pain, physical disability, pain catastrophizing, symptoms of depression and anxiety, and illness worry 5 months after participation in the program. Effect sizes ranged from medium (Cohen’s d: 0.50–0.77) for physical symptoms, self-efficacy, and illness worry to large (Cohen’s d: 0.89–1.51) for pain catastrophizing, physical disability, depression, and anxiety. Surprisingly we found a decrease in self-efficacy during the CPSMP. Perhaps the Danish version of CPSMP does not enhance self-efficacy in the same way as the original version did. But it could also be due to the scale used to measure self-efficacy in the present study which is a shortened and translated version of the scale used in a previous study [6]. A majority of participants scored above clinical cutoff in pain catastrophizing, disability, depression, anxiety, physical symptoms, and illness worry (28–86%). The proportion of clinically impaired participants was reduced with 30–50% during the CPMSP. When analyzing data at an individual level using a reliable change approach, only pain catastrophizing were reliably reduced in more than one quarter of the participants. The lack of control group is a major shortcoming of the present study. The applications of reliable change indices, which are calculated on the stability of the measures in similar populations, allow us to compare the level of change with a historical control group. This approach confirms the existence of statistically reliable improvement in a subgroup of participants but still we cannot determine whether this development can be ascribed to the CPSMP or could have occurred in other circumstances. 4.2. Conclusion We may conclude that the Danish version of the CPSMP was feasible. Generally the participants evaluated the CPSMP as satisfying and would recommend the program to other pain patients but about 10% were consistently dissatisfied with the program. Participants showed significant improvements on relevant measures of self-reported symptoms, albeit the scope of these changes was modest. It should also be noted that approximately 10% showed statistically reliable deterioration on some parameters during the CPMSP. Like the positive changes these negative changes may not be related to the intervention but potential negative effects of the CPMSP should be considered in future studies.
Acknowledgement The study was funded by Trygfonden, Denmark.
References [1] Classification of Chronic Pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain 1986;3:S1–226. [2] Leadley RM, Armstrong N, Lee YC, Allen A, Kleijnen J. Chronic diseases in the European Union: the prevalence and health cost implications of chronic pain. J Pain Palliat Care Pharmacother 2012;26:310–25. [3] Langley PC. The societal burden of pain in Germany: health-related quality-oflife, health status and direct medical costs. J Med Econ 2012;15:1201–15. [4] Tsang A, Von Korff M, Lee S, Alonso J, Karam E, Angermeyer MC, et al. Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders. J Pain 2008;9:883–91. [5] Lynch ME, Campbell F, Clark AJ, Dunbar MJ, Goldstein D, Peng P, et al. A systematic review of the effect of waiting for treatment for chronic pain. Pain 2008;136:97–116. [6] Lefort SM, Gray-Donald K, Rowat KM, Jeans ME. Randomized controlled trial of a community-based psychoeducation program for the self-management of chronic pain. Pain 1998;74:297–306. [7] Lorig K, Holman H. Arthritis self-management studies—a 12-year review. Health Educ Q 1993;20:17–28. [8] Bandura A. Self-efficacy—toward a unifying theory of behavioral change. Psychol Rev 1977;84:191–215. [9] Lorig KR, Holman HR. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med 2003;26:1–7. [10] Ersek M, Turner JA, Cain KC, Kemp CA. Results of a randomized controlled trial to examine the efficacy of a chronic pain self-management group for older adults [ISRCTN11899548]. Pain 2008;138:29–40. [11] Melzack R. The short-form Mcgill Pain Questionnaire. Pain 1987;30:191–7. [12] Roland M, Morris R. A study of the natural-history of back pain. 1. Development of a reliable and sensitive measure of disability in low-back-pain. Spine 1983;8:141–4. [13] Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB. Assessing health-related quality-of-life in patients with sciatica. Spine 1995;20: 1899–908. [14] Albert HB, Jensen AM, Dahl D, Rasmussen NK. Criteria validation of the Roland Morris questionnaire. A Danish translation of the international scale for the assessment of functional level in patients with low back pain and sciatica. Ugeskr Laeger 2003;165:1875–80. [15] Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess 1995;7:524–32. [16] Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum 1989;32:37–44. [17] Christensen KS, Fink P, Toft T, Frostholm L, Ornbol E, Olesen F. A brief casefinding questionnaire for common mental disorders: the CMDQ. Family Pract 2005;22:448–57. [18] Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychol Methods 2002;7:147–77. [19] Jacobson NS, Truax P. Clinical-significance—a statistical approach to defining meaningful change in psychotherapy-research. J Consult Clin Psychol 1991;59:12–9.
Contents lists available at ScienceDirect
Patient Education and Counseling journal homepage: www.elsevier.com/locate/pateducou
Short Communication
A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients Mimi Mehlsen a,*, Lea Heegaard b, Lisbeth Frostholm c a
Department of Psychology and Behavioural Sciences, Aarhus University, Denmark The Danish Committee for Health Education, Denmark c Research Clinic for Functional Disorders, Aarhus University Hospital, Denmark b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 9 September 2014 Received in revised form 7 January 2015 Accepted 10 January 2015
Objective: This study evaluates the feasibility and changes in pain, pain cognition, and distress during a patient education course and a 5-month follow-up period. The Chronic Pain Self-Management Programme (CPSMP) is a lay-led patient education consisting of six manualized sessions. Methods: A Danish adaptation of the CPSMP was tested in four municipalities. The sample consisted of 74 women and 13 men between 26 and 80 years with a long pain history (+10 years). Participants completed questionnaires before the CPSMP, immediately after and 5 months after the program. Results: The study showed that the Danish version of the CPSMP was feasible. The sample was heterogeneous with respect to age, education, duration and causes of pain but all participants reported serious pain and most experienced high levels of distress and disability. Participants evaluated the CPSMP as satisfying and more than 75% would recommend the program to other patients. Participants showed significant improvements on pain, disability, catastrophizing, depression, anxiety, and health worry, and changes were stable through the follow-up period. Conclusion: A consistent pattern of stable improvements in pain, pain cognition and distress was observed but the scope of changes was modest. Practice implications: The Danish version of the CPSMP is feasible. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Chronic pain Self-management Patient education Lay-led CPSMP
1. Background Chronic pain is pain which persists beyond normal tissue healing time, which is defined as 3 months [1]. The estimated prevalence of chronic pain in the European Union is 27% [2] with human costs such as a reduced quality of life [3], and an increased risk of developing common mental disorders [4]. Waiting lists for specialized pain clinics are often long with deterioration in health as an unacceptable consequence [5]. Therefore, low cost interventions have great individual and societal relevance. The Chronic Pain Self-Management Programme (CPSMP) is a patient education program targeting chronic pain patients [6]. The content of the CPSMP is similar to the Arthritis Self-Management Program, which has demonstrated efficacy in improving pain, selfefficacy, health behaviors and health care utilization in arthritis patients [7], but the CPSMP is adapted for various idiopathic
* Corresponding author at: Department of Psychology and Behavioural Sciences, Aarhus University, Denmark. Tel.: +45 87165874. E-mail address: [email protected] (M. Mehlsen). http://dx.doi.org/10.1016/j.pec.2015.01.008 0738-3991/ß 2015 Elsevier Ireland Ltd. All rights reserved.
chronic pain conditions [6]. The teaching methods used in the CPSMP are based on increasing participants’ self-efficacy, i.e. their belief in their own ability to set goals and implement behavioral changes, to reach their goals [8]. The program intends a high degree of participant involvement using the support of the group to strengthen participants’ self-efficacy. The program is not aimed at symptom-directed treatment of pain, rather the intention is to optimize pain management and to support rehabilitation and treatment processes [9]. In the first study on the effects of CPSMP in 110 participants with idiopathic pain, LeFort [6] found that participants reported less pain, less dependency on others, improved mental health, increased activity and satisfaction with their lives 3 months after end of treatment compared to a wait-list control. In the only other study of 256 older pain patients, improvements were found 6 and 12 months after a similar intervention, but there were no differences in effect when compared to patients receiving written material only [10]. In the present study we wished to examine the feasibility of a Danish version of the Canadian– American CPSMP measuring pre- to post intervention changes in relevant outcome measures.
678
M. Mehlsen et al. / Patient Education and Counseling 98 (2015) 677–680
2. Methods
3. Results
2.1. Recruitment
3.1. Sample
Data for the present study was obtained from a pilot test in four municipalities of the adapted Danish version of the Chronic Pain Self-Management Program. Participants were eligible if they were 18+ years, spoke Danish, had pain lasting more than 3 months, rated their pain intensity >5 on a 10-point scale. Pain should not be caused by conditions of primary concern to the participant, e.g. cancer in acute stage or pregnancy, and participants with substance abuse, psychiatric or physical disease that would disturb participation in the course were excluded. Questionnaires were collected 2–14 days before the course started (T1), 1–3 weeks after the course (T2), and 5–6 months after the course started (T3).
One-hundred eligible citizens were included in the program. Of these, 87 answered the baseline questionnaire, 69 returned the first follow-up questionnaire immediately after the course and 73 the second follow-up questionnaire. The participants were 26 to 80 years old, had suffered from chronic pain between 0 and 45 years. More than one cause of pain was reported by 48% and 5% marked 4–5 causes of pain. The most frequent causes of pain were tear/ work injury, diseases, and accidents, 16% reported the cause of their chronic pain to be unknown (Table 1).
2.2. Procedure Participants were invited to participate in the CPSMP by local professionals in health care and social work. After receiving information about the evaluation, they completed the baseline questionnaire. The CPSMP consisted of six 2.5 h weekly workshops focusing on how to manage pain in daily life. Two trained workshop leaders facilitated the workshops in groups of 8–16 chronic pain patients. At least one of the workshop leaders suffered from a long term pain condition. After the last session, follow-up questionnaires were mailed to all participants with a postage prepaid envelope (T2 and T3). Written reminders were sent after 2 weeks and after 4 weeks participants were contacted by phone. 2.3. Questionnaires At baseline questions about socio-demographic parameters, pain duration and cause were answered. Pain was measured by the VAS and the Present Pain Intensity index from the McGill Pain Questionnaire [11]. Physical disability was measured by the 23-item Modified Roland-Morris Disability Questionnaire [12–14]. Pain catastrophizing was measured by the 13-item Pain Catastrophizing Scale [15]. Pain-related Self-efficacy was measured by a 5-item modified version of Arthritis Selfefficacy Scale [16]. The Common Mental Disorders Questionnaire [17] included four subscales assessing: depression, anxiety, physical symptoms, and illness worry. To evaluate the program, 13 questions were constructed regarding satisfaction, and relations to workshop leaders and other participants. 2.4. Statistical method Missing data in psychometric scales were handled at item level. If more than half the items on any given scale were completed, missing scores were replaced by the mean of the completed items [18]. Changes in pain, disability, catastrophizing, self-efficacy and distress were tested by repeated measures ANOVAs. A reliable change index (RCI) was calculated to evaluate statistical reliable change in each participant [19]. The RCI is a function of the standard deviation of the measure and its reliability: SE = SD1(H(1 rxx). When the applied reliability parameter (r) is a test–retest correlation based on data from a comparable sample, it introduces a historical control. For outcomes where test–retest coefficients were available, we calculated the RCI. Percentages of participants displaying reliable change were estimated. Clinical significance of change was evaluated by comparison with published cutoff values. Percentages exceeding clinical cutoffs before and after intervention were estimated.
Table 1 Sample characteristics at baseline. Variable
N
Age Mean (SD)
52.0 (12.4)
Gender Women Men
74 (85%) 13 (15%)
Living alone Marital status Not married Married/partner Divorced Widowed
31 (36%)
Children in household
25 (29%)
Education None/unskilled Skilled Short (<3 yrs) Medium (3–4 yrs) Long (+5 yrs)
14 16 26 26 5
(16%) (18%) (30%) (30%) (6%)
Job status Student Working Sick leave Sheltered employment Unemployed Pension Other
1 5 11 17 3 40 9
(1%) (6%) (13%) (20%) (3%) (46%) (10%)
Diagnoses Cancer Lung disease Cardiac disease Neurological disease Psychiatric disorder Arthritis Diabetes Neck-back disorder Musculoskeletal disorder Other
4 8 4 6 8 25 5 50 44 19
(5%) (9%) (5%) (7%) (9%) (29%) (6%) (58%) (51%) (22%)
Pain duration in years Mean (SD)
14 55 11 7
(16%) (63%) (13%) (8%)
9.9 (9.8)
Pain intensity VAS (SD) (mm) Likert 0–5 point
58.3 (16.3) 3.1 (0.7)
Daily pain medication None Over the counter (OTC) drugs Prescription drugs Both OTC and prescription
15 10 27 34
(17%) (12%) (31%) (39%)
Taking extra pain medication Seldom Several times weekly Daily Several times daily
27 37 10 7
(31%) (43%) (12%) (8%)
M. Mehlsen et al. / Patient Education and Counseling 98 (2015) 677–680
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Table 2 Changes in outcome parameters from baseline to follow-up. Measure
Physical disability (range 0–23) Pain VAS (range 0–100 mm) Pain intensity (range 0–5) Pain Catastrophizing (range 0–42) Pain-related Self-efficacy (range 5–50) Depression (range 0–6) Anxiety (range 0–4) Somatic symptoms (range 0–12) Health worry (range 0–7) * **
Baseline
T2
T3
N: 83–86
N: 65–68
N: 67–73
M (SD)
M (SD)
M (SD)
14.5 (4.5) 58.3 (16.3) 3.13 (0.72) 25.4 (9.6) 21.6 (8.5) 3.53 (1.73) 2.10 (1.73) 7.72 (2.77) 4.05 (2.37)
12.5 (4.9) 54.4 (19.0) 3.02 (0.87) 20.5 (9.4) 22.3 (9.0) 2.85 (1.73) 1.80 (1.31) 7.19 (3.02) 3.84 (2.11)
12.3 (5.5) 50.8 (19.3) 2.63 (0.91) 20.0 (10.5) 20.6 (10.0) 2.54 (1.81) 1.52 (1.36) 7.06 (2.82) 3.21 (2.30)
Wilks’ Lambda
Effect size d
0.708*** 0.831** 0.733*** 0.636*** 0.905* 0.760*** 0.835** 0.942 0.876*
1.28 0.90 1.21 1.51 0.65 1.12 0.89 0.50 0.75
p < 0.05. p < 0.01. p < 0.001.
***
3.2. Changes from baseline to follow-up
3.4. Clinical significance
The response rate at T2 was 79%. Compared to responders, nonresponders at T2 had reported significantly more disability at baseline (t = 2.487, p = 0.016) but non-respondents did not differ on any other outcome measure or sociodemographic characteristic. A series of repeated measures ANOVA’s revealed significant reductions in pain, physical disability, pain catastrophizing, symptoms of depression and anxiety, illness worry and physical symptoms from baseline to immediately after the CPSMP (see Table 2). At 5-months follow-up changes remained significant.
To evaluate the clinical significance of changes we estimated the number of participants who changed status from severe levels of pain and disability and from pathological levels of pain catastrophizing, depressive symptoms, anxiety, illness worry and physical symptoms, see Table 4.
3.3. Reliable change To examine changes at an individual level reliable change indices (RCI) was calculated for the outcome measures, see Table 3.
3.5. Participation and evaluation of the program On average participants attended 5 out 6 six sessions. Most participants were satisfied with the program (75%) and would recommend it to other pain patients (78%). But it should also be noted that a subgroup of about 10% of the responders gave poor ratings on most aspects, including experiences of instructors and the atmosphere at the sessions.
Table 3 Reliable change criteria and percentage reliably improved and deteriorated from Baseline to T2 and from Baseline to T3. Measure
Physical disability Pain VAS Pain intensity Pain catastrophizing Self-efficacy
SD
R or ICC
RCI scale-points
3.9 25.7 1.05 8.9 22.5
0.78 0.87 0.82 0.85 0.87
5.11 262 1.22 9.63 22.44
Baseline to T2a
Baseline to T3b
Improve
Decline
Improve
Decline
6 5 3 16 0
0 2 1 2 1
13 8 9 25 0
0 2 1 3 3
(7%) (6%) (3%) (18%)
(2%) (1%) (2%) (1%)
(15%) (9%) (10%) (29%)
(2%) (1%) (3%) (3%)
RCI calculated based on data from 1 Ostelo et al. (2004), 2 Adelmanesh et al. (2011), 3 Fernandes et al. (2012) and 4 Lorig et al. (1989). a Note: Percentages are calculated based on total baseline sample, T2 data was missing in 22–26% of participants. b Note: Percentages are calculated based on total baseline sample, T3 data was missing in 17–25% of participants.
Table 4 Participants scoring above clinical cutoff for pathological levels and distribution on different levels of pain severity. Measure
Clinical cutoff
Above cutoff at baseline
Above cutoff at T2
Above cutoff at T3
Pain catastrophizing Disability Depression Anxiety Somatic symptoms Health worry
301 14 (high level of dysfunction)2 3 (Depressive disorder)3 3 (Anxiety disorder)3 5 (Any somatoform disorder)3 3 (Any somatoform disorder)3
24 52 58 32 75 58
10 33 36 18 54 47
11 34 32 17 55 37
Pain VAS
No pain (0–4)4 Mild pain (5–44) Moderate pain (45–74) Severe pain (75–100)
0 19 (22%) 53 (61%) 11 (13%)
Cutoff values published in
1
Sullivan (2009),
2
Dunn and Croft (2005),
3
(28%) (60%) (67%) (37%) (86%) (67%)
Christensen et al. (2005) and
(12%) (38%) (41%) (21%) (62%) (54%)
0 18 (21%) 40 (46%) 7 (8%) 4
Hawker et al. (2011).
(13%) (39%) (37%) (20%) (63%) (43%)
0 24 (28%) 36 (41%) 7 (8%)
680
M. Mehlsen et al. / Patient Education and Counseling 98 (2015) 677–680
4. Discussion and conclusion 4.1. Discussion In this prospective but uncontrolled study of the Danish CPSMP, we found significant reductions in pain, physical disability, pain catastrophizing, symptoms of depression and anxiety, and illness worry 5 months after participation in the program. Effect sizes ranged from medium (Cohen’s d: 0.50–0.77) for physical symptoms, self-efficacy, and illness worry to large (Cohen’s d: 0.89–1.51) for pain catastrophizing, physical disability, depression, and anxiety. Surprisingly we found a decrease in self-efficacy during the CPSMP. Perhaps the Danish version of CPSMP does not enhance self-efficacy in the same way as the original version did. But it could also be due to the scale used to measure self-efficacy in the present study which is a shortened and translated version of the scale used in a previous study [6]. A majority of participants scored above clinical cutoff in pain catastrophizing, disability, depression, anxiety, physical symptoms, and illness worry (28–86%). The proportion of clinically impaired participants was reduced with 30–50% during the CPMSP. When analyzing data at an individual level using a reliable change approach, only pain catastrophizing were reliably reduced in more than one quarter of the participants. The lack of control group is a major shortcoming of the present study. The applications of reliable change indices, which are calculated on the stability of the measures in similar populations, allow us to compare the level of change with a historical control group. This approach confirms the existence of statistically reliable improvement in a subgroup of participants but still we cannot determine whether this development can be ascribed to the CPSMP or could have occurred in other circumstances. 4.2. Conclusion We may conclude that the Danish version of the CPSMP was feasible. Generally the participants evaluated the CPSMP as satisfying and would recommend the program to other pain patients but about 10% were consistently dissatisfied with the program. Participants showed significant improvements on relevant measures of self-reported symptoms, albeit the scope of these changes was modest. It should also be noted that approximately 10% showed statistically reliable deterioration on some parameters during the CPMSP. Like the positive changes these negative changes may not be related to the intervention but potential negative effects of the CPMSP should be considered in future studies.
Acknowledgement The study was funded by Trygfonden, Denmark.
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