Clinical trial NCT06635213: Effectiveness of Desensitisation and Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain
Official title: Determination of the Effectiveness of Desensitisation and Pain Neuroscience Training in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain Phenotype
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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).

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.

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

Primary outcomes:
measure: Pressure Paın Threshold Measurement
timeFrame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
measure: Boston Carpal Tunnel Questionnaire - Symptom Severity Scale
timeFrame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
measure: Boston Carpal Tunnel Questionnaire - Functional Status Scale
timeFrame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
measure: Pain Catastrophising Scale
timeFrame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
measure: Tampa Kinesiophobia Scale
timeFrame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
measure: Numerical Rating Scale
timeFrame: [at the beginning of the study] [At the end of 6 weeks] [3 months later]
Secondary outcomes:
measure: Cold Pain Threshold
timeFrame: 2 minutes
measure: Hot Pain Threshold
timeFrame: 2 minutes
measure: Pressure Pain Threshold
timeFrame: 3 minutes
measure: Mechanical Pain Threshold
timeFrame: 3 minutes
measure: Dynamic Mechanical Allodynia
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
References: