Chronic PainNCT06084390
Interdisciplinary Rehabilitation for Chronic Pain in Primary Healthcare
A study testing Interdisciplinary care + booster session (intervention) in people with Chronic Pain and Pain Management, run by Vastra Gotaland Region at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Pain Management
- What is being tested?
- Interdisciplinary care + booster session (intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 13 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons participating in interdisciplinary team rehabilitation in primary healthcare in Region Västra Götaland, Sweden.
Who cannot join
- Severe psychiatric disease, language difficulties that makes it impossible to complete the questionnaires
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Research and development primary health care Fyrbodal
Vänersborg, Region Västra Götaland, 46235
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Pain Management
- Being tested
- Interdisciplinary care + booster session (intervention), Interdisciplinary care (control)
- Keywords
- randomised controlled trial, primary care
- Medical subject headings
- Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interdisciplinary care + booster session (intervention) |
| Interdisciplinary rehabilitation (control) | Active comparator | Standard care by the interdisciplinary rehabilitation teams in primary healthcare. Receives: Other: Interdisciplinary care (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Assessed with visual analog scale and numeric rating scale (0-100 mm, higher is more severe pain)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Secondary outcomes (14)
Pain spread
The participants mark in boxes painful areas
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: From 12 months before to 24 months after the rehabilitation period.
Sickness abscence
Sickness absence data
Measured: From 12 months before to 24 months after the rehabilitation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start13 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anna Bergenheim, Dr, Principal investigator, Research and development primary healthcare Fyrbodal, region Västra Götaland, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084390
- Sponsor's protocol ID
- Painteam
- Status last verified
- Aug 2026
- First submitted
- 10 Oct 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Rehabilitation for Patients With Chronic Pain in Primary Healthcare
- ClinicalTrials.gov ID
- NCT06084390
- Acronym / sponsor ID
- Painteam
- Conditions
- Chronic Pain, Pain Management
- Keywords
- randomised controlled trial, primary care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary rehabilitation + booster-session (intervention) | Experimental | Other: Interdisciplinary care + 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. |
| Interdisciplinary rehabilitation (control) | Active comparator | Other: Interdisciplinary care (control)Standard care by the interdisciplinary rehabilitation teams in primary healthcare. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persons participating in interdisciplinary team rehabilitation in primary healthcare in Region Västra Götaland, Sweden.
Key exclusion criteria (1 listed)
- Severe psychiatric disease, language difficulties that makes it impossible to complete the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Interdisciplinary rehabilitation + booster-session (intervention) |
| Interdisciplinary care (control)Standard care for interdisciplinary rehabilitation at any of the six interdisciplinary teams in primary health care in Region Västra Götaland, Sweden. | Other | Interdisciplinary rehabilitation (control) |
Primary outcome
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)
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)
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)
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)
14 secondary outcomes
Pain spread
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Pain acceptance
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Self-efficacy
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from from the end of the rehabilitation period.
Symptoms of stress
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Physical activity
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Anxiety and depression
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Self-rated function
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Work ability
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Life satisfaction
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Fatigue
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Pain catastrophizing
Time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
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.
Health care use
Time frame: From 12 months before to 24 months after the rehabilitation period.
Sickness abscence
Time frame: From 12 months before to 24 months after the rehabilitation period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Bergenheim, Dr principal investigator
Research and development primary healthcare Fyrbodal, region Västra Götaland, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary care + booster session (intervention) in people with Chronic Pain and Pain Management, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.