The Effect of Carpal Tunnel Syndrome Phenotyping on Response to Treatment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKutahya Health Sciences University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being diagnosed with CTS

Being suitable for the neuropathic pain phenotype

Being between the ages of 18-65

Volunteering to participate in the study

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Rehabilitation Protocol

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Homogeneous Neuropathic PhenotypeExperimental treatment 1 intervention
Group B: Heterogeneous Unclassified PhenotypeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numerical Rating Scale

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

Time frame
Baseline, 6 weeks, 12 weeks
2

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.

Time frame
Baseline, 6 weeks, 12 weeks
3

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.

Time frame
Baseline, 6 weeks, 12 weeks
4

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.

Time frame
Baseline, 6 weeks, 12 weeks

Secondary outcomes

1

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).

Time frame
2 minutes
2

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).

Time frame
2 minutes
3

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).

Time frame
3 minutes
4

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).

Time frame
3 minutes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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