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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06358326
Other study ID # Karabuk-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 5, 2024
Est. completion date September 30, 2024

Study information

Verified date April 2024
Source Karabuk University
Contact Musa Gunes, MsC
Phone 0 (370) 418 9081
Email musagunes@karabuk.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dry needling is used for myofascial release. However, its effectiveness in carpal tunnel syndrome (CTS) is not well known. It is thought that dry needling may also be an effective treatment for CTS by providing relaxation in the fascial tissue. Therefore, this study will examine the effects of dry needling treatment on pain, function, range of motion, proprioception and disability in patients with CTS.


Description:

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the society, which develops due to compression of the median nerve in the carpal tunnel. With the compression of the median nerve, a pain, numbness and tingling sensation spreading to the hand and wrist affects daily living activities and reduces the quality of life. Thickening and myofascial restriction in the carpal tunnel area also contribute to this situation. For this reason, various treatment methods have been developed for CTS, ranging from conservative treatment to surgery. Dry needling is also an alternative treatment method that can be used for CTS. Dry needling allows the fascial tissue to loosen and re-enter the healing process, leading to a decrease in pain and an increase in quality of life. However, its effectiveness in patients with CTS is unknown. This study aimed to examine the effectiveness of dry needling in patients with CTS.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Volunteering to participate in the study. 2. Being between the ages of 18-65. 3. Being diagnosed with mild or moderate stage CTS as a result of the electroneurophysiological test. Exclusion Criteria: 1. Having additional neurological, rheumatological and orthopedic disorders. 2. Having had previous hand surgery. 3. Having an additional acute neck, shoulder, elbow and hand problem. 4. Having a BMI of 40 kg/m2 and above. 5. Being pregnant. 6. As a result of the electroneurophysiological test, the data related to the median nerve are at a severe level.

Study Design


Intervention

Other:
Dry needling
In addition to stretching, nerve mobilization and tendon gliding exercises, a total of 5 sessions of dry needling will be performed for fascial mobilization, 2 days a week for 3 weeks.
Control group
The physiotherapist will teach stretching, neuromobilization and tendon shifting exercises and will be asked to do them regularly for 3 weeks.

Locations

Country Name City State
Turkey Pursaklar State Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain severity It will be evaluated with the Visual Analogue Scale. The scale ranges from 1 to 10 at 10 mm intervals. 0 indicates absence of pain and the highest value of 10 indicates extreme pain. Baseline and 3 weeks post-intervention
Primary Wrist range of motion Wrist flexion, extension, ulnar deviation and radial deviation joint range degrees will be measured using a universal goniometer. Baseline and 3 weeks post-intervention
Primary Position sense In the evaluation of joint position sense (proprioception), wrist extension, elbow flexion and shoulder flexion movements will be evaluated with an inclinometer. An increase in deviation from the target angle indicates a worsening of position sense. Baseline and 3 weeks post-intervention
Primary Severity of symptoms The patients' CTS-related symptom severity and functional status will be evaluated with the Boston Carpal Tunnel Syndrome Questionnaire. The severity of the patient's strain is scored between 1-5. Higher scores indicate greater disability. Baseline and 3 weeks post-intervention
Primary Functional status Upper Extremity Functional Index will be used to evaluate the functional disability of the upper extremity. Scoring ranges from 0 to 100 points, with a higher score indicating a higher activity level. Baseline and 3 weeks post-intervention
Primary Hands activity level Duruöz hand index will be used to evaluate hand-related activity limitations. The survey yields a total score of 0-90, with a higher score indicating greater activity restriction. Baseline and 3 weeks post-intervention
Primary neuropathic pain severity Neuropathic pain will be evaluated with the Neuropathic Pain Questionnaire. The change of 4 points determined as the neuropathic pain threshold will be examined. Baseline and 3 weeks post-intervention
Primary Nerve cross-sectional area With ultrasonography, the doctor will measure the median nerve cross-sectional area of the individual and the distance between the median nerve flexor retinaculum. Baseline and 3 weeks post-intervention
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