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NCT Number: NCT06410963

ReActivate: Physiotherapist Led Intervention for A Adolescents and Young Adults With Musculoskelatal Pain

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Pain Emotional Distress Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Örebro county

Örebro, 70217, Sweden

About this study

See description of arms and intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • Serious/malignant disease
  • Participation in other rehabilitation program
  • Severe mental health problems
  • Substance abuse
  • Severe learning disabilities

Treatment and study plan

Reactivate

Behavioral

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.

Primary outcomes

  1. 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 )

  2. 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)

Secondary outcomes

  1. Functional Disability Inventory (FDI) change

    Time frame: baseline, after treatment phase B (12 weeks), 6 months after terminated intervention

    Change in functional disability. Descriptive Rating Scale, range 0-64 (higher values, worse outcome)

  2. 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

    Change in depressive symptoms. Descriptive Rating Scale, range 0-60 (higher values, worse outcome)

  3. 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 quality of life. Descriptive Rating Scale, range 0-92 (higher values, worse outcome)

  4. 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.

    Change in self-related symptoms of psychological distress. Numerical Rating Scale, range 0-6 (3 questions, higher values, worse outcome)

  5. 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.

    Change in self-related pain symptoms. Numerical Rating Scale range 0-6 (higher values, worse outcome)

  6. 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

    Change in fear of pain. Descriptiv Rating Scale, range 0-40 (higher values worse outcome)

  7. 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)

    Change in percieved harmfulness. Photographs with 50 activities, rated on a Subjective Self-rating Scale, range 0-100mm/item (higher values, worse outcome)

Other outcomes

  1. Treatment Inventory of Costs in Patients with psychiatric disorders (Tic-P), medical resources

    Time frame: baseline, 12 weeks, 6 months after terminated intervention

    Change in use of medical resources. Dichotomous scale completed by open ended answers if answer is yes.

  2. Treatment Inventory of Costs in Patients with psychiatric disorders (Tic-P), school absence

    Time frame: baseline, 12 weeks, 6 months after terminated intervention

    Change in school abcense. Dichotomous scale completed by open ended answers if answer is yes. One question is completed by one question with Numerical Rating Scale 1-10 (higher values, worse outcome) if answer is yes.

  3. Accelerometer

    Time frame: 7 days of the first week of baseline (randomly assigned to be 7, 14 or 21 days). 7 days assessment 6 months after terminated assessment.

    Change in physical activity, digital device counting steps

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Region Örebro County

Registry information

Official study title

ReActivate: Physiotherapist Led Intervention for Adolescents and Young Adults With Musculoskeletal Pain; A Sequential Replicated and Randomized Single Case Experimental Design (SCED)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 13, 2024
Registry last updated
Apr 14, 2026

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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