Purpose: The overall aim is to investigate the effect of interdisciplinary rehabilitation in primary health care (PHC) for patients with chronic pain. Specific questions: What is the effect of extended access to the interdisciplinary PHC pain team + a booster session after finishing the rehabilitation program? Does participation in PHC interdisciplinary rehabilitation contribute to health improvements and are there predictors of this? Method: A randomized controlled trial (RCT). 200 patients with chronic pain that participate in interdisciplinary rehabilitation in primary healthcare in Region Västra Götaland (VGR) in Sweden will be included in the RCT and randomized to Intervention; standard care by the interdisciplinary teams in PHC + extended access to the team and a booster session 3 months after the end of the rehabilitation, or Control; only standard care by the interdisciplinary teams. Outcomes are health related quality of life, pain intensity and other health aspects.
The participants will be randomly allocated to intervention or active control. All participants in both arms receive the standard care for interdisciplinary rehabilitation at any of the six PHC pain teams in VGR. The teams consist of a physician, physiotherapist, occupational therapist and psychologist. All teams provide person-centred rehabilitation, aiming to increase physical activity and support behavioural changes, and to decrease symptoms and the impact of pain on the patients´ daily lives. The standard care interdisciplinary rehabilitation period contains both theoretical and practical components such as patient education, physical exercise and behavioural interventions. The sessions are mainly group-based. The duration of the rehabilitation period varies between 5 to 7 weeks + a follow-up visit after 3 months. The participants in the intervention arm also receive an extra booster-session 3 months after the standard follow-up. At the booster-session, the participant´s individual rehabilitation plan is followed-up and adjusted. This extra period also includes extended access to the team, meaning that the participants have the possibility to contact the team and, if needed, have digital or telephone contact. The participants complete a battery of questionaires included in the Swedish Quality Registry for Pain Rehabilitation an also extra questionnaires provided to the participants through an electronic research form. Data collection is made at baseline before starting the rehabilitation, directly after the 5 to 7 weeks rehabilitation period and 6, 12 and 24 months after baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Standard care for interdisciplinary rehabilitation at any of the six interdisciplinary teams in primary health care in Region Västra Götaland, Sweden + one extra booster-session 3 months after the standard care rehabilitation. At the booster-session, the participant´s individual rehabilitation plan is followed-up and adjusted. This extra period also includes extended access to the team, meaning that the participants have the possibility to contact the team and, if needed, have digital or telephone contact.
Standard care for interdisciplinary rehabilitation at any of the six interdisciplinary teams in primary health care in Region Västra Götaland, Sweden.
Research and development primary health care Fyrbodal
Vänersborg, Region Västra Götaland, Sweden
Pain intensity
Assessed with visual analog scale and numeric rating scale (0-100 mm, higher is more severe pain)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Health related quality of life
Rand-36 (0-100, a higher score indicates better health-related quality of life)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Health related quality of life 2
EuroQol 5D-3L (0-100, a higher score indicates better health-related quality of life)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Health related quality of life 3
EuroQol-Visual analogue scale (0-100, a higher score indicates better health-related quality of life)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Pain spread
The participants mark in boxes painful areas
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Pain acceptance
The Chronic pain acceptance questionnaire (CPAQ-8) (Total score 0-48, 2 subscales 0-24 p. Higher score means better pain acceptance)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Self-efficacy
The Pain self-efficacy questionnaire short-form (PSEQ\_2) (0-12, a higher score means better self-efficacy)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from from the end of the rehabilitation period.
Symptoms of stress
The stress and crisis inventory (SCI-93) (0-140, a higher score means more stress) symptoms)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Physical activity
The Godin questionnaire (hours of physical activity per week)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Anxiety and depression
The hospital anxiety and depression scale (2 subscales for symptoms of anxiety and depression ranging from 0 to 21, a higher value means a higher degree of anxiety or depression)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Self-rated function
The Functional rating index (0-100 %, higher percent is worse)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Work ability
One question (number 7) from the Work ability index (0-10, higher score is better)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Life satisfaction
The LiSat questionnaire (2 questions ranging 1-6, higher score is better life satisfaction)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Fatigue
The multidimensional fatigue inventory (5 subscales ranging from 4 -20, higher score means more fatigue)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Pain catastrophizing
The pain catastrophizing scale (Total score 0-52, higher score is worse)
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Patients´ own impression of change
Patient global impression of change (1-7, lower score means more improvement)
Time frame: Directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Health care use
Health care visit statistics
Time frame: From 12 months before to 24 months after the rehabilitation period.
Sickness abscence
Sickness absence data
Time frame: From 12 months before to 24 months after the rehabilitation period.
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