Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain
CompletedNot applicableNCT05915611
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Other: Standardized Carpal Tunnel Syndrome Rehabilitation
- Behavioral: Psychologically Informed Pain-Management Program
- Behavioral: Attention-Matched Health Education
- Sponsor
- Ahram Canadian University
- Start date
- 2023-07-02
- Primary completion
- 2026-05-11
- Sex
- All
- Age range
- from 25 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Egypt
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adults aged 25-65 years with unilateral or bilateral carpal tunnel syndrome confirmed by compatible clinical findings and electrodiagnostic evidence of median neuropathy at the wrist. * CTS-related symptoms present for ≥3 months. * Mild-to-moderate CTS suitable for nonsurgical management. * Coexisting mixed neuropathic-nociplastic pain features according to a CTS-adapted IASP-aligned clinical algorithm. Exclusion Criteria: * Previous carpal tunnel release surgery on the study side. * Severe CTS with marked thenar weakness/atrophy, severe axonal loss, or other findings requiring prompt surgical evaluation. * Cervical radiculopathy or cervical myelopathy judged to better explain the upper-extremity symptoms. * Proximal median neuropathy or other clinically important peripheral entrapment neuropathy. * Generalized polyneuropathy. * Major shoulder, elbow, wrist, or hand disorder considered the dominant cause of symptoms or disability. * Recent corticosteroid injection or other invasive CTS treatment within a prespecified washout period. * Concurrent structured CTS rehabilitation outside the study protocol. * Previous participation in a structured psychological pain-management program during the recent prespecified period. * Medical, cognitive, or communication limitations preventing safe participation or valid completion of study procedures.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05915611