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

N/AActive Not RecruitingNCT06410963

Örebro University, Sweden35 enrolled

Overview

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.

See description of arms and intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Pain Emotional Distress

Interventions

ReactivateBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Locations (1)

Region Örebro county

Örebro, Sweden

Outcomes

Primary Outcomes

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 )

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

Symptom distress change

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

Secondary Outcomes

Functional Disability Inventory (FDI) change

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

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

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

Time frame: 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)

Time frame: 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)

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

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

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

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

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

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

Time frame: First session after baseline (randomly assigned to be 7, 14 or 21 days), after treatment phase B (12 weeks)

Data from ClinicalTrials.gov

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