Clinical trial NCT06084390: Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare
Official title: Interdisciplinary Rehabilitation for Patients With Chronic Pain in Primary Healthcare
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Pain Management
Keywords: randomised controlled trial
primary care
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2023-10-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Persons participating in interdisciplinary team rehabilitation in primary healthcare in Region Västra Götaland, Sweden.

Exclusion Criteria:

* Severe psychiatric disease, language difficulties that makes it impossible to complete the questionnaires

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Health related quality of life
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Health related quality of life 2
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Health related quality of life 3
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Secondary outcomes:
measure: Pain spread
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Pain acceptance
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Self-efficacy
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from from the end of the rehabilitation period.
measure: Symptoms of stress
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Physical activity
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Anxiety and depression
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Self-rated function
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Work ability
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Life satisfaction
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Fatigue
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Pain catastrophizing
timeFrame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Patients´ own impression of change
timeFrame: Directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
measure: Health care use
timeFrame: From 12 months before to 24 months after the rehabilitation period.
measure: Sickness abscence
timeFrame: From 12 months before to 24 months after the rehabilitation period.
Other outcomes:
Locations:
city: Vänersborg
country: Sweden
facility: Research and development primary health care Fyrbodal
state: Region Västra Götaland
Study officials:
affiliation: Research and development primary healthcare Fyrbodal, region Västra Götaland, Sweden
name: Anna Bergenheim, Dr
role: PRINCIPAL_INVESTIGATOR
References: