Chronic PainNCT06410963
ReActivate: Physiotherapist Led Intervention for A Adolescents and Young Adults With Musculoskelatal Pain
A study testing Reactivate in people with Chronic Pain and Emotional Distress, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
Recurrent or persistent musculoskeletal pain is an alarmingly common problem among adolescents, in Sweden as well as globally. Pain often co-occur with and psychological distress and have both been shown to be predictors of sustained problems in adulthood. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Chronic Pain, Emotional Distress
- What is being tested?
- Reactivate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSweden
- Study dates
- 23 Sep 2024to 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-25
- Persistent (consistently or weekly recurrent) musculoskeletal pain problems for ≥3 months, with pain intensity ≥2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent)
- Presence of avoidance behaviour and/or or worry about symptoms/problems, ≥1 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent); > 50 on at least one activity of the PHODA.
- Swedish speaking and able to fill out questionnaires
Who cannot join
- Serious/malignant disease
- Participation in other rehabilitation program
- Severe mental health problems
- Substance abuse
- Severe learning disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ReActivate: Physiotherapist Led Intervention for Adolescents and Young Adults With Musculoskeletal Pain; A Sequential Replicated and Randomized Single Case Experimental Design (SCED)
Recurrent or persistent musculoskeletal pain is an alarmingly common problem among adolescents, in Sweden as well as globally. Pain often co-occur with and psychological distress and have both been shown to be predictors of sustained problems in adulthood. Adequate treatment early on in the development of problems has been shown important in order to decrease the risk of sustained problems in adulthood but available treatments have only modest effects. There is thus a need for treatment development, not in the least for (secondary) preventative purposes. The aim of this project is therefore to develop an evidence based and cost-effective secondary preventative intervention. Specifically, this project aims to develop and test a physiotherapist led treatment for adolescents with recurrent or persistent musculoskeletal pain and based upon graded exposure to physical activity and reactivation.
Read the detailed description
See description of arms and intervention.
- Conditions
- Chronic Pain, Emotional Distress
- Being tested
- Reactivate
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReactivateBehavioural
The study period is 84 days (12 weeks). Depending on the length of the baseline period (randomly assigned to be 7, 14 or 21 days), the treatment period varies between 63-77 days and contains 6-11 sessions. The intervention consists of 2-4 educational sessions in pain mechanisms and fear avoidance and 4-9 sessions of individually tailored intervention with graded exposure and reactivation to avoided physical activities. Intervention will take place from one time per week to one time every two weeks, 30-60 minutes per session. Number of treatment sessions will depend on when the individual participants' goals are considered reached. If necessary, given the participants consent, their legal guardians will be invited to attend the sessions.
| Study group | Role | What they receive |
|---|---|---|
| No treatment waiting period | No intervention | Participants are randomized to a 7, 14 or 21 day waiting period. Daily measurements are collected throughout this period. |
| Reactivate | Experimental | Reactivate treatment. Daily measurements are collected throughout treatment. Receives: Behavioral: Reactivate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity engagement change
Change in self-rated activity engagement. Numerical Rating Scale, range 0-6 (1 question: lower values, worse outcome, 1 question: Lower values, better outcome )
Measured: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention
Symptom distress change
Change in self-rated distress about symptoms. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome)
Measured: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention.
Secondary outcomes (7)
Functional Disability Inventory (FDI) change
Change in functional disability. Descriptive Rating Scale, range 0-64 (higher values, worse outcome)
Measured: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
Center of Epidemiological Studies Depression Scales for Children (CES-DC) change
Change in depressive symptoms. Descriptive Rating Scale, range 0-60 (higher values, worse outcome)
Measured: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
The Pediatric Quality of Life Acute version (PedsQL) PedsQL™
Change in quality of life. Descriptive Rating Scale, range 0-92 (higher values, worse outcome)
Measured: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
Change in psychological distress
Change in self-related symptoms of psychological distress. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome)
Measured: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment.
Pain change
Change in self-related pain symptoms. Numerical Rating Scale range 0-6 (higher values, worse outcome)
Measured: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment.
Fear of Pain Questionnaire Children Short-form (FOPQ-C SF) change
Change in fear of pain. Descriptiv Rating Scale, range 0-40 (higher values worse outcome)
Measured: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
The Photograph Series of Daily Activities for youth (PHODA) change - short
Change in percieved harmfulness. Photographs with 50 activities, rated on a Subjective Self-rating Scale, range 0-100mm/item (higher values, worse outcome)
Measured: First session after baseline (randomly assigned to be 7, 14 or 21 days), after treatment phase B (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start23 Sep 2024
- Primary completion30 Nov 2026 (estimated)
- Study completionDec 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.
- 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
- Single group
- Model description
- This study employs a sequential single-case experimental AB design with randomized waiting period lengths (7, 14 or 21 days). Included in the design is also standardized pre-post and 6-month follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from participating adolescents.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Region Örebro County
- Responsible party
- Sponsor
- Investigators
- Katja Boersma, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410963
- Sponsor's protocol ID
- Reactivate
- Status last verified
- Apr 2026
- First submitted
- 8 May 2024
- Last updated
- 14 Apr 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReActivate: Physiotherapist Led Intervention for Adolescents and Young Adults With Musculoskeletal Pain; A Sequential Replicated and Randomized Single Case Experimental Design (SCED)
- ClinicalTrials.gov ID
- NCT06410963
- Acronym / sponsor ID
- Reactivate
- Conditions
- Chronic Pain, Emotional Distress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Region Örebro County
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 May 2024 (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.
Recurrent or persistent musculoskeletal pain is an alarmingly common problem among adolescents, in Sweden as well as globally. Pain often co-occur with and psychological distress and have both been shown to be predictors of sustained problems in adulthood. Adequate treatment early on in the development of problems has been shown important in order to decrease the risk of sustained problems in adulthood but available treatments have only modest effects. There is thus a need for treatment development, not in the least for (secondary) preventative purposes. The aim of this project is therefore to develop an evidence based and cost-effective secondary preventative intervention. Specifically, this project aims to develop and test a physiotherapist led treatment for adolescents with recurrent or persistent musculoskeletal pain and based upon graded exposure to physical activity and reactivation.
Detailed description
See description of arms and intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study employs a sequential single-case experimental AB design with randomized waiting period lengths (7, 14 or 21 days). Included in the design is also standardized pre-post and 6-month follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from participating adolescents.
| Arm | Type | Receives |
|---|---|---|
| No treatment waiting period | No intervention | –Participants are randomized to a 7, 14 or 21 day waiting period. Daily measurements are collected throughout this period. |
| Reactivate | Experimental | Behavioral: ReactivateReactivate treatment. Daily measurements are collected throughout treatment. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 12-25
- Persistent (consistently or weekly recurrent) musculoskeletal pain problems for ≥3 months, with pain intensity ≥2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent)
- Presence of avoidance behaviour and/or or worry about symptoms/problems, ≥1 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent); > 50 on at least one activity of the PHODA.
- Swedish speaking and able to fill out questionnaires
Key exclusion criteria (5 listed)
- Serious/malignant disease
- Participation in other rehabilitation program
- Severe mental health problems
- Substance abuse
- Severe learning disabilities
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 |
|---|---|---|
| ReactivateThe study period is 84 days (12 weeks). Depending on the length of the baseline period (randomly assigned to be 7, 14 or 21 days), the treatment period varies between 63-77 days and contains 6-11 sessions. The intervention consists of 2-4 educational sessions in pain mechanisms and fear avoidance and 4-9 sessions of individually tailored intervention with graded exposure and reactivation to avoided physical activities. Intervention will take place from one time per week to one time every two weeks, 30-60 minutes per session. Number of treatment sessions will depend on when the individual participants' goals are considered reached. If necessary, given the participants consent, their legal guardians will be invited to attend the sessions. | Behavioural | Reactivate |
Primary outcome
Activity engagement change
Time frame: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention
Change in self-rated activity engagement. Numerical Rating Scale, range 0-6 (1 question: lower values, worse outcome, 1 question: Lower values, better outcome )
Symptom distress change
Time frame: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention.
Change in self-rated distress about symptoms. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome)
7 secondary outcomes
Functional Disability Inventory (FDI) change
Time frame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
Center of Epidemiological Studies Depression Scales for Children (CES-DC) change
Time frame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
The Pediatric Quality of Life Acute version (PedsQL) PedsQL™
Time frame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
Change in psychological distress
Time frame: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment.
Pain change
Time frame: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84days). 7 days assessment 6 months after terminated assessment.
Fear of Pain Questionnaire Children Short-form (FOPQ-C SF) change
Time frame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention
The Photograph Series of Daily Activities for youth (PHODA) change - short
Time frame: First session after baseline (randomly assigned to be 7, 14 or 21 days), after treatment phase B (12 weeks)
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 14 Apr 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.
Katja Boersma, PhD principal investigator
Örebro University, 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 Reactivate in people with Chronic Pain and Emotional Distress, run by Örebro University, Sweden 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 4 inclusion and 5 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 14 Apr 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?
Activity engagement change (time frame: repeated daily through phase A (randomly assigned to be 7, 14 or 21 days) and treatment phase B (9-11 weeks). Total time frame of assessment is 12 weeks (84 days). 7 days assessment 6 months after terminated intervention). The study lists 2 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 14 Apr 2026.