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Clinical Trials/NCT06084390
NCT06084390
Active, Not Recruiting
N/A

Interdisciplinary Rehabilitation for Patients With Chronic Pain in Primary Healthcare

Vastra Gotaland Region1 site in 1 country200 target enrollmentOctober 13, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Vastra Gotaland Region
Enrollment
200
Locations
1
Primary Endpoint
Health related quality of life
Status
Active, Not Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 13, 2023
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Vastra Gotaland Region
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Rand-36 (0-100, a higher score indicates better health-related quality of life)

Pain intensity

Time Frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.

Assessed with visual analog scale and numeric rating scale (0-100 mm, higher is more severe pain)

Health related quality of life 2

Time Frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.

EuroQol 5D-3L (0-100, a higher score indicates better health-related quality of life)

Health related quality of life 3

Time Frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.

EuroQol-Visual analogue scale (0-100, a higher score indicates better health-related quality of life)

Secondary Outcomes

  • Self-efficacy(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from from the end of the rehabilitation period.)
  • Pain spread(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
  • Pain catastrophizing(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
  • Health care use(From 12 months before to 24 months after the rehabilitation period.)
  • Pain acceptance(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
  • Symptoms of stress(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
  • Physical activity(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
  • Self-rated function(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
  • Work ability(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
  • Sickness abscence(From 12 months before to 24 months after the rehabilitation period.)
  • Anxiety and depression(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
  • Life satisfaction(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
  • Patients´ own impression of change(Directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
  • Fatigue(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)

Study Sites (1)

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