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Recruiting NCT06635213

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

No phase Interventional Carpal Tunnel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Desensitisation, Pain neuroscience education.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Determination of the Effectiveness of Desensitisation and Pain Neuroscience Training in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain Phenotype

Overview

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

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.

Interventions

  • Other Desensitisation
    This technique is utilized to decrease, or normalize, the body's response to particular sensations.
  • Other Pain neuroscience education
    PNE is an educational intervention aiming to alter a patient's beliefs and cognitions regarding their pain experience.

Primary outcome measures

  • Pressure Paın Threshold Measurement [Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
  • Boston Carpal Tunnel Questionnaire - Symptom Severity Scale [Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
  • Boston Carpal Tunnel Questionnaire - Functional Status Scale [Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
  • Pain Catastrophising Scale [Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
  • Tampa Kinesiophobia Scale [Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
  • Numerical Rating Scale [Time frame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
Secondary outcome measures (5)
  • Cold Pain Threshold [Time frame: 2 minutes]
  • Hot Pain Threshold [Time frame: 2 minutes]
  • Pressure Pain Threshold [Time frame: 3 minutes]
  • Mechanical Pain Threshold [Time frame: 3 minutes]
  • Dynamic Mechanical Allodynia [Time frame: 3 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Kutahya Health Science University — Kütahya

Identifiers

NCT: NCT06635213 · 2024-b

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗