- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997823
Dorsovolar Kinesiotape in Carpal Tunnel Syndrome
January 26, 2024 updated by: Emine Cihan, Selcuk University
Is Dorso-Volar Kinesiotape Added to the Home Exercise Program Effective in the Treatment of Carpal Tunnel Syndrome?-Prospective Randomized Controlled Study
This study aimed to compare the short- and medium-term efficacy of dorso-volar kinesiotape (KT) added to home exercises (HE) with sham-KT and HE alone in the treatment of mild or moderate carpal tunnel syndrome (CTS) in terms of pain, symptom severity, function, grip strength, and electrophysiological parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Deince
-
Kocaeli, Deince, Turkey
- Health Sciences University, Kocaeli Derince Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- pain or numbness radiating to the palm for at least 6 weeks,
- at least one positive Tinel's, Phalen's, or carpal compression test on physical examination, and
- mild/moderate CTS on EMG examination.
Exclusion Criteria:
- Metabolic disease (diabetes, rheumatoid arthritis, thyroid disease),
- systemic or malignant disease, history of trauma, fracture or surgery to the wrist,
- physical therapy programs, surgical procedures, injections or KT applications to the wrist for CTS treatment in the past year,
- severe thenar atrophy,
- C6-C7 radiculopathy among CTS differential diagnoses,
- cervical spondylosis, thoracic outlet syndrome, entrapment of the median nerve above the wrist,
- polyneuropathy or traumatic injury to the median nerve,
- rashes or open wounds on the skin of the wrist and forearm that could prevent treatment with kinesiology taping
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: home exercises
|
home exercises
|
Experimental: sham-KT and home exercises
|
home exercises
The button hole technique was used for area correction during the KT application (Figure 1).
Two I-tapes were applied, one from the medial epicondyle to the proximal phalanx on the palmar side and the other from the lateral epicondyle to the proximal phalanx on the dorsal side.
The area where the phalanges are located was marked, and two hole was drilled in the center.After cleaning the skin with alcohol, the tape to be applied to the palmar side was passed over the 3rd and 4th fingers, and the patient was asked to perform radial deviation and wrist extension
|
Experimental: dorso-volar KT and home exercises
|
home exercises
The button hole technique was used for area correction during the KT application (Figure 1).
Two I-tapes were applied, one from the medial epicondyle to the proximal phalanx on the palmar side and the other from the lateral epicondyle to the proximal phalanx on the dorsal side.
The area where the phalanges are located was marked, and two hole was drilled in the center.After cleaning the skin with alcohol, the tape to be applied to the palmar side was passed over the 3rd and 4th fingers, and the patient was asked to perform radial deviation and wrist extension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electrodiagnostic Evaluation
Time Frame: 30 minutes
|
Superficial recording electrodes were placed in the abductor pollicis brevis (APB) muscles (recording stimulus distance 5 cm) for median nerve motor conduction and in the abductor digiti minimi (ADM) muscles (recording stimulus distance 5 cm) for ulnar nerve motor conduction.Superficial recording electrodes were placed on the 3rd finger for median nerve sensory conduction (recording stimulus distance 13 cm) and on the 5th finger for ulnar nerve sensory conduction (recording stimulus distance 11 cm).The ground electrode was placed between the recording and stimulus electrodes for all electrophysiological tests.Sensory latency, amplitude, and conduction velocity of the median nerve and motor latency, amplitude, and conduction velocity were recorded
|
30 minutes
|
Hand Strength
Time Frame: 10 minutes
|
A Jamar hand dynamometer (Baseline ® hydraulic hand dynamometer, Irvington, NY, USA) was used to measure handgrip strength.
|
10 minutes
|
Pain Evaluation
Time Frame: 5 minutes
|
A 10-point visual analog scale (VAS) was used to rate pain.
Patients were asked to rate the pain they felt at rest, at night, and with movement with a number ranging from 0 (no pain) to 10 (very severe), VAS movement, VAS night, and VAS rest
|
5 minutes
|
Finger Strength
Time Frame: 10 minutes
|
A pinch meter (Baseline ® hydraulic pinch gauge, Irvington, NY, USA) was used to evaluate lateral grip strength (LGS) and pinch grip strength
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
July 29, 2023
Study Registration Dates
First Submitted
August 11, 2023
First Submitted That Met QC Criteria
August 16, 2023
First Posted (Actual)
August 18, 2023
Study Record Updates
Last Update Posted (Actual)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/11-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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