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

NCT ID: NCT06635213

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-25

Study Completion Date

2027-06-10

Brief Summary

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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).

Detailed Description

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People between the ages of 18-65, diagnosed with Carpal Tunnel Sedrome, who are suitable for the Nosiplastic pain phenotype and who volunteer to participate in the study will be included. The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain will be applied to patients with CTS. 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. Numerical rating scale (NRS) will be used for pain assessment. Boston Carpal Tunnel Questionnaire - Symptom Severity Scale will be used for symptom severity assessment and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used for functional status assessment. Pressure pain threshold will be measured with an algometer to evaluate hypersensitivity. The Pain Catastrophising Scale and the Tampa Kinesiophobia Scale will be administered to the patients. Normality of the data distribution will be assessed using the Shapiro-Wilk test. Fischer'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, post-intervention, 3 months post-intervention) different outcome measures (pain intensity, symptom severity, functional status, pain catastrophising and kinesiophobia) to detect between-group differences.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1 (desensitisation)

Group 1 will receive desensitisation.

Group Type ACTIVE_COMPARATOR

Desensitisation

Intervention Type OTHER

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

Group 2 (desensitisation and pain neuroscience education)

Group 2 will receive desensitisation and pain neuroscience education.

Group Type ACTIVE_COMPARATOR

Desensitisation

Intervention Type OTHER

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

Pain neuroscience education

Intervention Type OTHER

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

Interventions

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Desensitisation

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

Intervention Type OTHER

Pain neuroscience education

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being diagnosed with CTS
* Being suitable for the nosiplastic 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Emrah Afsar

Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kutahya Health Science University

Kütahya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Emrah Afsar, Phd

Role: CONTACT

5062527008

Ayse Kocak Sezgin, Phd

Role: CONTACT

+90 5072243706

Facility Contacts

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Emrah Afsar, Phd

Role: primary

5062527008

Other Identifiers

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2024-b

Identifier Type: -

Identifier Source: org_study_id

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