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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain; Emotional Distress
• Intervention / Treatment: Behavioral: Reactivate

Detailed Description

See description of arms and intervention.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70217
    • Region Örebro county

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No treatment waiting period; Participants are randomized to a 7, 14 or 21 day waiting period. Daily measurements are collected throughout this period.
Experimental: Reactivate; Reactivate treatment. Daily measurements are collected throughout treatment.	Behavioral: Reactivate; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Disability Inventory (FDI) change	Change in functional disability. Descriptive Rating Scale, range 0-64 (higher values, worse outcome)	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)	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)	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)	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)	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)	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)	First session after baseline (randomly assigned to be 7, 14 or 21 days), after treatment phase B (12 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Inventory of Costs in Patients with psychiatric disorders (Tic-P), medical resources	Change in use of medical resources. Dichotomous scale completed by open ended answers if answer is yes.	baseline, 12 weeks, 6 months after terminated intervention
Treatment Inventory of Costs in Patients with psychiatric disorders (Tic-P), school absence	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.	baseline, 12 weeks, 6 months after terminated intervention
Accelerometer	Change in physical activity, digital device counting steps	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.

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Region Örebro County
• Investigators: Principal Investigator: Katja Boersma, PhD, Örebro University, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: Reactivate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No