Effectiveness of Desensitisation and Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain

NCT06635213 | Recruiting

• 1 other identifier: 2024-b
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study was to determine the effectiveness of desensitisation and pain neuroscience education in a group of patients with mixed phenotype pain (neuropathic and nosiplastic).

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (6)

• Pressure Paın Threshold Measurement

  The pressure pain threshold (PPT), the minimum amount of pressure at which the pressure sensation changes to pain, is measured with an electronic algometer (median nerve, ulnar nerve and radial nerve, C5-C6 zygapophyseal joint level (proximal), and tibialis anterior). Participants are asked to report when the sensation changes from pressure to pain. The mean of the three trials is calculated (with a 30 s rest interval in between).

  [at the beginning of the study] [At the end of 6 weeks] [3 months later]

• 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.

  [at the beginning of the study] [At the end of 6 weeks] [3 months later]

• 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.

  [at the beginning of the study] [At the end of 6 weeks] [3 months later]

• Pain Catastrophising Scale

  The Catastrophising Pain Scale (PCS) is used to measure catastrophising in response to pain through 13 statements with four possible options from 1 "never" to 4 "always". Higher scores indicate greater catastrophised pain.

  [at the beginning of the study] [At the end of 6 weeks] [3 months later]

• Tampa Kinesiophobia Scale

  It is a 17-question scale. The scale has a 4-point Likert scale (1= Strongly disagree, 4= Strongly agree). After reversing items 4, 8, 12 and 16, a total score is calculated. The person receives a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.

  [at the beginning of the study] [At the end of 6 weeks] [3 months later]

• Numerical Rating Scale

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

  [at the beginning of the study] [At the end of 6 weeks] [3 months later]

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)

Group 1 (desensitisation)

ACTIVE COMPARATOR

Group 1 will receive desensitisation.

Other: Desensitisation

Group 2 (desensitisation and pain neuroscience education)

ACTIVE COMPARATOR

Group 2 will receive desensitisation and pain neuroscience education.

Other: Desensitisation; Other: Pain neuroscience education

Interventions

Desensitisation OTHER

This technique is utilized to decrease, or normalize, the body's response to particular sensations.

Group 1 (desensitisation); Group 2 (desensitisation and pain neuroscience education)

Pain neuroscience education OTHER

PNE is an educational intervention aiming to alter a patient's beliefs and cognitions regarding their pain experience.

Group 2 (desensitisation and pain neuroscience education)

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 nosiplastic 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

Study Sites (1)

Kutahya Health Science University

Kütahya, Turkey (Türkiye)

RECRUITING

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

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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Model Details: After determining the predominant pain phenotype in patients with CTS, patients with mixed type (neuropathic and nosiplastic pain phenotype) will be randomly divided into two groups. One group (Group 1) will receive desensitisation and the other group (Group 2) will receive desensitisation and pain neuroscience education.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): April 25, 2027
• Study Completion (Estimated): June 10, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

TU (1)