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Active, Not Recruiting

NCT Number: NCT06084390

Interdisciplinary Rehabilitation for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research and development primary health care Fyrbodal

Vänersborg, Region Västra Götaland, 46235, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 care (control)

Other

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

Primary outcomes

  1. Pain intensity

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

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

  2. Health related quality of life

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

    Rand-36 (0-100, a higher score indicates better health-related quality of life)

  3. Health related quality of life 2

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

    EuroQol 5D-3L (0-100, a higher score indicates better health-related quality of life)

  4. Health related quality of life 3

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

    EuroQol-Visual analogue scale (0-100, a higher score indicates better health-related quality of life)

Secondary outcomes

  1. Pain spread

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

    The participants mark in boxes painful areas

  2. Pain acceptance

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

    The Chronic pain acceptance questionnaire (CPAQ-8) (Total score 0-48, 2 subscales 0-24 p. Higher score means better pain acceptance)

  3. Self-efficacy

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

    The Pain self-efficacy questionnaire short-form (PSEQ_2) (0-12, a higher score means better self-efficacy)

  4. Symptoms of stress

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

    The stress and crisis inventory (SCI-93) (0-140, a higher score means more stress) symptoms)

  5. Physical activity

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

    The Godin questionnaire (hours of physical activity per week)

  6. Anxiety and depression

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

    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)

  7. Self-rated function

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

    The Functional rating index (0-100 %, higher percent is worse)

  8. Work ability

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

    One question (number 7) from the Work ability index (0-10, higher score is better)

  9. Life satisfaction

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

    The LiSat questionnaire (2 questions ranging 1-6, higher score is better life satisfaction)

  10. Fatigue

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

    The multidimensional fatigue inventory (5 subscales ranging from 4 -20, higher score means more fatigue)

  11. Pain catastrophizing

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

    The pain catastrophizing scale (Total score 0-52, higher score is worse)

  12. Patients´ own impression of change

    Time frame: Directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.

    Patient global impression of change (1-7, lower score means more improvement)

  13. Health care use

    Time frame: From 12 months before to 24 months after the rehabilitation period.

    Health care visit statistics

  14. Sickness abscence

    Time frame: From 12 months before to 24 months after the rehabilitation period.

    Sickness absence data

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

Interdisciplinary Rehabilitation for Patients With Chronic Pain in Primary Healthcare

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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