Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare

Sponsor
Vastra Gotaland Region (Other)
Overall Status
Recruiting
CT.gov ID
NCT06084390
Collaborator
(none)
200
1
2
38
5.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interdisciplinary care + booster session (intervention)
  • Other: Interdisciplinary care (control)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Interdisciplinary Rehabilitation for Patients With Chronic Pain in Primary Healthcare
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interdisciplinary rehabilitation + booster-session (intervention)

Standard care by the interdisciplinary rehabilitation teams in primary healthcare + extended access to the team and a booster visit after 3 months.

Other: Interdisciplinary care + booster session (intervention)
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.

Active Comparator: Interdisciplinary rehabilitation (control)

Standard care by the interdisciplinary rehabilitation teams in primary healthcare.

Other: Interdisciplinary care (control)
Standard care for interdisciplinary rehabilitation at any of the six interdisciplinary teams in primary health care in Region Västra Götaland, Sweden.

Outcome Measures

Primary Outcome Measures

  1. Pain intensity [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    Assessed with visual analog scale and numeric rating scale

  2. Health related quality of life [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    Assessed with RAND-36, EQ5D-3L, EQ-VAS

Secondary Outcome Measures

  1. Pain spread [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    The participants mark in boxes painful areas.

  2. Pain acceptance [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    The Chronic pain acceptance questionnaire

  3. Self-efficacy [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    The Pain self-efficacy questionnaire short-form

  4. Symptoms of stress [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    The stress and crisis inventory (SCI-93)

  5. Physical activity [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    The Godin questionnaire

  6. Anxiety and depression [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    The hospital anxiety and depression scale

  7. Self-rated function [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    The Functional rating index

  8. Work ability [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    One question from the Work ability index

  9. Life satisfaction [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    The LiSat questionnaire

  10. Fatigue [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    The multidimensional fatigue inventory

  11. Pain catastrophizing [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    The pain catastrophizing scale

  12. Patients´ own impression of change [Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.]

    Patient global impression of change

  13. Health care use [From 12 months before to 24 months after the rehabilitation period]

    Health care visit statistics

  14. Sickness abscence [From 12 months before to 24 months after the rehabilitation period]

    Sickness absence data

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research and development primary health care Fyrbodal Vänersborg Region Västra Götaland Sweden 46235

Sponsors and Collaborators

  • Vastra Gotaland Region

Investigators

  • Principal Investigator: Anna Bergenheim, Dr, Research and development primary healthcare Fyrbodal, region Västra Götaland, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vastra Gotaland Region
ClinicalTrials.gov Identifier:
NCT06084390
Other Study ID Numbers:
  • Painteam
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vastra Gotaland Region
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2023