Back to resultsDorsovolar Kinesiotape in Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome Treatment
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
kinesiotape
home exercises
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome Treatment focused on measuring carpal tunnel syndromes, kinesiotape, electromyography, median neuropathy, muscle strength, pain
Eligibility Criteria
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
Sites / Locations
- Health Sciences University, Kocaeli Derince Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
home exercises
sham-KT and home exercises
dorso-volar KT and home exercises
Arm Description
Outcomes
Primary Outcome Measures
Electrodiagnostic Evaluation
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
Hand Strength
A Jamar hand dynamometer (Baseline ® hydraulic hand dynamometer, Irvington, NY, USA) was used to measure handgrip strength.
Pain Evaluation
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
Finger Strength
A pinch meter (Baseline ® hydraulic pinch gauge, Irvington, NY, USA) was used to evaluate lateral grip strength (LGS) and pinch grip strength
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05997823
Brief Title
Dorsovolar Kinesiotape in Carpal Tunnel Syndrome
Official Title
Is Dorso-Volar Kinesiotape Added to the Home Exercise Program Effective in the Treatment of Carpal Tunnel Syndrome?-Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome Treatment
Keywords
carpal tunnel syndromes, kinesiotape, electromyography, median neuropathy, muscle strength, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
home exercises
Arm Type
Active Comparator
Arm Title
sham-KT and home exercises
Arm Type
Experimental
Arm Title
dorso-volar KT and home exercises
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
kinesiotape
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
home exercises
Intervention Description
home exercises
Primary Outcome Measure Information:
Title
Electrodiagnostic Evaluation
Description
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
Time Frame
30 minutes
Title
Hand Strength
Description
A Jamar hand dynamometer (Baseline ® hydraulic hand dynamometer, Irvington, NY, USA) was used to measure handgrip strength.
Time Frame
10 minutes
Title
Pain Evaluation
Description
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
Time Frame
5 minutes
Title
Finger Strength
Description
A pinch meter (Baseline ® hydraulic pinch gauge, Irvington, NY, USA) was used to evaluate lateral grip strength (LGS) and pinch grip strength
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Health Sciences University, Kocaeli Derince Training and Research Hospital
City
Kocaeli
State/Province
Deince
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Dorsovolar Kinesiotape in Carpal Tunnel Syndrome
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