ReActivate: Physiotherapist Led Intervention for Adolescents With Pain and Psychological Distress.

Chronic Pain Clinical Trial

Official title:

ReActivate: Physiotherapist Led Intervention for Adolescents With Pain and Psychological Distress. A Sequential Replicated and Randomized Single Case Experimental Design (SCED).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410963
• Other study ID #: Reactivate
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Örebro University, Sweden
• Contact: Tove Axelsson-Landberg, MSc
• Phone: +46 736318264
• Email: tove.axelssonlandberg[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recurrent or persistent pain and psychological distress are alarmingly common problems among adolescents, in Sweden as well as globally. They often co-occur and have 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 pain and psychological distress based upon graded exposure to physical activity and reactivation.

Description:

See description of arms and intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

• Age 12-19

• Psychological distress, such as anxiety, depressive symptoms or stress, =2 on a numeric rating scale 0-6 (0=not at all, 6=to a great extent)

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Emotional Distress

Intervention

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.

Locations

Country	Name	City	State
Sweden	Region Örebro county	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
Örebro University, Sweden	Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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.
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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)