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Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare

Primary Purpose

Chronic Pain, Pain Management

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Interdisciplinary care + booster session (intervention)
Interdisciplinary care (control)
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring randomised controlled trial, primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research and development primary health care FyrbodalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interdisciplinary rehabilitation + booster-session (intervention)

Interdisciplinary rehabilitation (control)

Arm Description

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

Standard care by the interdisciplinary rehabilitation teams in primary healthcare.

Outcomes

Primary Outcome Measures

Pain intensity
Assessed with visual analog scale and numeric rating scale
Health related quality of life
Assessed with RAND-36, EQ5D-3L, EQ-VAS

Secondary Outcome Measures

Pain spread
The participants mark in boxes painful areas.
Pain acceptance
The Chronic pain acceptance questionnaire
Self-efficacy
The Pain self-efficacy questionnaire short-form
Symptoms of stress
The stress and crisis inventory (SCI-93)
Physical activity
The Godin questionnaire
Anxiety and depression
The hospital anxiety and depression scale
Self-rated function
The Functional rating index
Work ability
One question from the Work ability index
Life satisfaction
The LiSat questionnaire
Fatigue
The multidimensional fatigue inventory
Pain catastrophizing
The pain catastrophizing scale
Patients´ own impression of change
Patient global impression of change
Health care use
Health care visit statistics
Sickness abscence
Sickness absence data

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT06084390
Brief Title
Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare
Official Title
Interdisciplinary Rehabilitation for Patients With Chronic Pain in Primary Healthcare
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Pain Management
Keywords
randomised controlled trial, primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interdisciplinary rehabilitation + booster-session (intervention)
Arm Type
Experimental
Arm Description
Standard care by the interdisciplinary rehabilitation teams in primary healthcare + extended access to the team and a booster visit after 3 months.
Arm Title
Interdisciplinary rehabilitation (control)
Arm Type
Active Comparator
Arm Description
Standard care by the interdisciplinary rehabilitation teams in primary healthcare.
Intervention Type
Other
Intervention Name(s)
Interdisciplinary care + booster session (intervention)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Interdisciplinary care (control)
Intervention Description
Standard care for interdisciplinary rehabilitation at any of the six interdisciplinary teams in primary health care in Region Västra Götaland, Sweden.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Assessed with visual analog scale and numeric rating scale
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Health related quality of life
Description
Assessed with RAND-36, EQ5D-3L, EQ-VAS
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Secondary Outcome Measure Information:
Title
Pain spread
Description
The participants mark in boxes painful areas.
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Pain acceptance
Description
The Chronic pain acceptance questionnaire
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Self-efficacy
Description
The Pain self-efficacy questionnaire short-form
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Symptoms of stress
Description
The stress and crisis inventory (SCI-93)
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Physical activity
Description
The Godin questionnaire
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Anxiety and depression
Description
The hospital anxiety and depression scale
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Self-rated function
Description
The Functional rating index
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Work ability
Description
One question from the Work ability index
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Life satisfaction
Description
The LiSat questionnaire
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Fatigue
Description
The multidimensional fatigue inventory
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Pain catastrophizing
Description
The pain catastrophizing scale
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Patients´ own impression of change
Description
Patient global impression of change
Time Frame
Baseline, directly after the rehabilitation period and 6, 12 and 24 months from baseline.
Title
Health care use
Description
Health care visit statistics
Time Frame
From 12 months before to 24 months after the rehabilitation period
Title
Sickness abscence
Description
Sickness absence data
Time Frame
From 12 months before to 24 months after the rehabilitation period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Bergenheim, Dr
Phone
+46104416290
Email
anna.c.bergenheim@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Eriksson, Dr
Email
maria.christina.eriksson@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Bergenheim, Dr
Organizational Affiliation
Research and development primary healthcare Fyrbodal, region Västra Götaland, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research and development primary health care Fyrbodal
City
Vänersborg
State/Province
Region Västra Götaland
ZIP/Postal Code
46235
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Bergenheim, Dr
Phone
+46104416290
Email
anna.c.bergenheim@vgregion.se

12. IPD Sharing Statement

Plan to Share IPD
No

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Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare

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