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COMPLETED
NCT05915611
NA

Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain

Sponsor: Ahram Canadian University

View on ClinicalTrials.gov

Summary

This randomized, assessor-blinded, parallel-group trial evaluated the effectiveness of adding a psychologically informed pain-management intervention to standardized physical rehabilitation in adults with electrodiagnostically confirmed carpal tunnel syndrome and coexisting mixed neuropathic-nociplastic pain features. A total of 178 participants were randomized in a 1:1 ratio. The active treatment period lasted 6 weeks, with follow-up through 12 weeks after randomization. The primary outcome was the Boston Carpal Tunnel Questionnaire-Symptom Severity Scale at 6 weeks.

Official title: Effectiveness of a Combined Physical and Psychologically Informed Intervention in Adults With Carpal Tunnel Syndrome and Coexisting Nociplastic Pain Features: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2023-07-02

Completion Date

2026-06-22

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

OTHER

Standardized Carpal Tunnel Syndrome Rehabilitation

Participants will receive a standardized 6-week physical rehabilitation program for carpal tunnel syndrome. Treatment will include night-time neutral-position wrist splinting, flexor-tendon gliding exercises, median-nerve neurodynamic exercises, education regarding activities that provoke symptoms, and a standardized home-exercise program. Supervised physical therapy will be provided twice weekly for 6 weeks, for a total of 12 supervised sessions. Participants will be instructed to perform the prescribed home exercises between supervised sessions.

BEHAVIORAL

Psychologically Informed Pain-Management Program

Participants will receive six individual psychologically informed pain-management sessions, approximately 40-45 minutes each, delivered once weekly over 6 weeks. The program will include pain neuroscience education, identification and modification of maladaptive pain beliefs, cognitive restructuring, strategies to reduce pain catastrophizing and fear of movement, graded exposure to feared upper-extremity activities, activity pacing, coping and self-management strategies, and relapse-prevention planning. The intervention will be delivered in addition to standardized CTS rehabilitation.

BEHAVIORAL

Attention-Matched Health Education

Participants will receive six individual health-education sessions, approximately 40-45 minutes each, delivered once weekly over 6 weeks. Sessions will be matched approximately to the experimental psychological intervention for therapist contact, frequency, and duration. Content will include general information regarding healthy lifestyle, sleep hygiene, physical activity, and general hand health. The sessions will not include pain neuroscience education, cognitive restructuring, pain-catastrophizing management, graded exposure, or other specific psychologically informed pain-management strategies.

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt