Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare

NCT06084390 | Active Not Recruiting

• 1 other identifier: Painteam
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Pain Management

Keywords

randomised controlled trial; primary care

Outcome Measures

Primary Outcomes (4)

• Pain intensity

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

  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)

  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)

  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)

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

Secondary Outcomes (14)

• Pain spread

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

• Pain acceptance

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

• Self-efficacy

  Baseline, directly after the rehabilitation period and 6, 12 and 24 months from 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.

Study Arms (2)

Interdisciplinary rehabilitation + booster-session (intervention)

EXPERIMENTAL

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)

Interdisciplinary rehabilitation (control)

ACTIVE COMPARATOR

Standard care by the interdisciplinary rehabilitation teams in primary healthcare.

Other: Interdisciplinary care (control)

Interventions

Interdisciplinary care + booster session (intervention) OTHER

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.

Interdisciplinary rehabilitation + booster-session (intervention)

Interdisciplinary care (control) OTHER

Standard care for interdisciplinary rehabilitation at any of the six interdisciplinary teams in primary health care in Region Västra Götaland, Sweden.

Interdisciplinary rehabilitation (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Research and development primary health care Fyrbodal

Vänersborg, Region Västra Götaland, 46235, Sweden

Location

MeSH Terms

Conditions

Chronic Pain; Agnosia

Interventions

Methods

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Anna Bergenheim, Dr

  Research and development primary healthcare Fyrbodal, region Västra Götaland, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: October 13, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)