Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare

Interdisciplinary Rehabilitation for Patients With Chronic Pain in Primary Healthcare

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Pain Management
• Intervention / Treatment: Other: Interdisciplinary care + booster session (intervention); Other: Interdisciplinary care (control)

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Bergenheim, Dr; Phone Number: +46104416290; Email: anna.c.bergenheim@vgregion.se
• Study Contact Backup: Name: Maria Eriksson, Dr; Email: maria.christina.eriksson@vgregion.se

Study Locations

• Sweden
  • Region Västra Götaland
    • Vänersborg, Region Västra Götaland, Sweden, 46235
      • Recruiting
      • Research and development primary health care Fyrbodal
      • Contact: Anna Bergenheim, Dr; Phone Number: +46104416290; Email: anna.c.bergenheim@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain spread	The participants mark in boxes painful areas	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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	From 12 months before to 24 months after the rehabilitation period.
Sickness abscence	Sickness absence data	From 12 months before to 24 months after the rehabilitation period.

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Anna Bergenheim, Dr, Research and development primary healthcare Fyrbodal, region Västra Götaland, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: primary care; randomised controlled trial
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: Painteam

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No