The Effect of Carpal Tunnel Syndrome Phenotyping on Response to Treatment

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Standard Rehabilitation Protocol

Detailed Description

People between the ages of 18-65, diagnosed with Carpal Tunnel Syndrome, who are suitable for the Neuropathic pain phenotype and who volunteer to participate in the study will be included. The 7 steps in the Clinical Criteria/Rating System for Carpal Tunnel Syndrome as defined by the International Association for the Study of Pain (IASP) will be applied to patients with CTS. 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 nociplastic pain phenotype) (Group 2). Training, exercise, and wrist splinting will be applied to both groups. The training will include a presentation and booklet on the pathophysiology of CTS, treatment options (conservative treatment and surgery), posture and activity modification principles. Participants will be given a programme of median nerve sliding and tendon sliding exercises as home exercises. The numerical rating scale (NRS) scale will be used for pain assessment. Boston Carpal Tunnel Questionnaire - Symptom Severity Scale, Boston Carpal Tunnel Questionnaire - Functional Status Scale, Michigan Hand Results Questionnaire (MHQ) will be used. Normality of data distribution will be assessed using the Shapiro-Wilk test. Fisher's exact test and chi-square test will be used to verify the relationship between categorical variables. A mixed model ANOVA will be performed on 2 (group 1 and group 2) x 3 (time: baseline, week 6 and week 12) different outcome measures (pain intensity, symptom severity, functional status, Michigan Hand Results Questionnaire (MHQ)) to detect between-group differences.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayse Kocak Sezgin, Phd; Phone Number: +90 5072243706; Email: ayse.kocaksezgin@ksbu.edu.tr
• Study Contact Backup: Name: Emrah Afsar, Phd; Phone Number: 5062527008; Email: emrah.afsar@ksbu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Homogeneous Neuropathic Phenotype; 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; A comprehensive standard rehabilitation program consisting of patient education, application of a clinical splint, and a structured exercise.
Active Comparator: Heterogeneous Unclassified Phenotype; 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; A comprehensive standard rehabilitation program consisting of patient education, application of a clinical splint, and a structured exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cold Pain Threshold	For cold pain threshold, ice cubes (-5°C) placed in a plastic bag will be placed on the patients' skin for 10 seconds. Increased sensory perception will be considered as gain of function. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain) to 10 (worst pain imaginable).	2 minutes
Pressure Pain Threshold	A digital algometer will be used to measure Pressure Pain Threshold levels. Pressure will be applied at a rate of approximately 30 kPa/s with the algometer placed perpendicular to the point of application. Participants will be instructed to report when the sensation changes from pressure to pain. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain at all) to 10 (worst pain imaginable).	3 minutes
Mechanical Pain Threshold	Mechanical pain threshold: to be assessed with a toothpick and a von Frey filament (256 mN). Increased sensory perception will be considered to reflect gain of function. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain at all) to 10 (worst pain imaginable).	3 minutes
Dynamic Mechanical Allodynia	Patients will be touched on the affected area and the control area with a brush, an ear stick and a piece of cotton wool. The assessment tools will be applied 4 times by drawing a cross of 2 strokes (length 5 cm) at an angle of 90˚C in each direction. For each stimulus (brush/ear swab/cotton swab), they will indicate (1) whether the stimulus was perceived as painful (yes/no) and (2) the pain intensity on the NRS-11 (0 no pain, 10 imaginably worse pain).	3 minutes
Hot Pain Threshold	Thermal pain perception will be tested using a metal piece equal to (lab-QST thermode size). The metal parts will be heated to 45˚C for hot pain threshold. The metal pieces will be applied to the skin for 3 seconds. It will be determined whether the stimulus is painful (yes/no), and if painful, the intensity of the pain on a numerical rating scale (NRS) (0: no pain, 10: imaginably worse pain).	2 minutes

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: Emrah Afsar, Phd, Kutahya Health Science University

Study record dates

Study Major Dates

• Study Start (Estimated): October 27, 2026
• Primary Completion (Estimated): October 27, 2027
• Study Completion (Estimated): December 27, 2027

Study Registration Dates

• First Submitted: July 25, 2026
• First Submitted That Met QC Criteria: August 4, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: Treatment Response in CTS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No