The Effect of Carpal Tunnel Syndrome Phenotyping on Response to Treatment

NCT07754708 | Not Yet Recruiting

• 1 other identifier: Treatment Response in CTS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to evaluate the effect of Carpal Tunnel Syndrome (CTS) phenotyping on responsiveness to clinical interventions in individuals with CTS.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (4)

• Numerical Rating Scale

  Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").

  Baseline, 6 weeks, 12 weeks

• Boston Carpal Tunnel Questionnaire - Symptom Severity Scale

  Boston Carpal Tunnel Questionnaire - Symptom Severity Scale is an 11-item questionnaire used to assess symptom severity in individuals with CTS. Each item is scored from 1 to 5. Scores range from 1 (no symptoms) to 5 (worst symptoms). The patient's symptom severity score is the average score of 11 items.

  Baseline, 6 weeks, 12 weeks

• Boston Carpal Tunnel Questionnaire - Functional Status Scale

  Boston Carpal Tunnel Questionnaire - Functional Status Scale is an 8-item questionnaire used to assess the functional status of patients with CTS. Each item is scored from 1 to 5. Scores range from 1 (no functional deficit) to 5 (worst possible function). The patient's functional status score is the average of all 8 items.

  Baseline, 6 weeks, 12 weeks

• Michigan Hand Questionnaire (MHQ)

  The Michigan Hand Questionnaire (MHQ) is a hand-specific questionnaire that measures the health status of patients with acute and chronic hand disorders. The MHQ is an outcome tool consisting of 37 questions and 6 domains: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with function. Each domain is scored using an unweighted method by summing the responses on each scale (1 to 5) and normalising the scores to a scale from 0 to 100. A lower score indicates more severe disability, other than pain. The final score is obtained by averaging the six scores after inverting the pain score.

  Baseline, 6 weeks, 12 weeks

Secondary Outcomes (5)

• Cold Pain Threshold

  2 minutes

• Hot Pain Threshold

  2 minutes

• Pressure Pain Threshold

  3 minutes

• Mechanical Pain Threshold

  3 minutes

• Dynamic Mechanical Allodynia

  3 minutes

Study Arms (2)

Homogeneous Neuropathic Phenotype

EXPERIMENTAL

Participants assigned to this arm present with a clinically determined, homogeneous neuropathic phenotype. All individuals in this group will receive a standard rehabilitation protocol consisting of patient education, splint application, and a structured exercise program.

Other: Standard Rehabilitation Protocol

Heterogeneous Unclassified Phenotype

ACTIVE COMPARATOR

Participants assigned to this arm do not have a specifically classified neuropathic phenotype and present with heterogeneous characteristics. All individuals in this group will receive the same standard rehabilitation protocol consisting of patient education, splint application, and a structured exercise program.

Other: Standard Rehabilitation Protocol

Interventions

Standard Rehabilitation Protocol OTHER

A comprehensive standard rehabilitation program consisting of patient education, application of a clinical splint, and a structured exercise.

Heterogeneous Unclassified Phenotype; Homogeneous Neuropathic Phenotype

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with CTS
• Being suitable for the neuropathic pain phenotype
• Being between the ages of 18-65
• Volunteering to participate in the study

You may not qualify if:

• Having systemic inflammatory disease
• Having a disease that may cause polyneuropathy such as diabetes mellitus
• Having a pacemaker
• Having a disease affecting the central nervous system
• Having cervical radiculopathy
• History of previous operation or local steroid injection due to CTS
• Hypersensitivity to heat and cold

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Emrah Afsar, Phd

  Kutahya Health Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emrah Afsar, Phd

CONTACT

5062527008; emrah.afsar@ksbu.edu.tr

Ayse Kocak Sezgin, Phd

CONTACT

+90 5072243706; ayse.kocaksezgin@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Occupational Therapy

Model Details: After determining the dominant pain phenotype in patients with CTS, one group will consist of patients with homogeneous neuropathic pain phenotype (Group 1). The heterogeneous group will consist of patients with neuropathic and mixed pain phenotype (both neuropathic and nosiplastic pain phenotype) (Group 2).

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): October 27, 2026
• Primary Completion (Estimated): October 27, 2027
• Study Completion (Estimated): December 27, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08