Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare

Chronic Pain Clinical Trial

Official title:

Interdisciplinary Rehabilitation for Patients With Chronic Pain in Primary Healthcare

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084390
• Other study ID #: Painteam
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Vastra Gotaland Region
• Contact: Anna Bergenheim, Dr
• Phone: +46104416290
• Email: anna.c.bergenheim[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain Management

Intervention

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

Locations

Country	Name	City	State
Sweden	Research and development primary health care Fyrbodal	Vänersborg	Region Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Health care use	Health care visit statistics	From 12 months before to 24 months after the rehabilitation period.
Secondary	Sickness abscence	Sickness absence data	From 12 months before to 24 months after the rehabilitation period.