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

NCT06410963 | Active Not Recruiting

• 1 other identifier: Reactivate
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Pain; Emotional Distress

Outcome Measures

Primary Outcomes (2)

• 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 )

  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)

  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

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

• Center of Epidemiological Studies Depression Scales for Children (CES-DC) change

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

• The Pediatric Quality of Life Acute version (PedsQL) PedsQL™

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

• Change in psychological distress

  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

  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.

Other Outcomes (3)

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

  baseline, 12 weeks, 6 months after terminated intervention

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

  baseline, 12 weeks, 6 months after terminated intervention

• Accelerometer

  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.

Study Arms (2)

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.

Behavioral: Reactivate

Interventions

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.

Reactivate

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Region Örebro County: collaborator

Study Sites (1)

Region Örebro county

Örebro, 70217, Sweden

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katja Boersma, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)