- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04993703
Effect of Kinesiotaping and Night Splinting in Patients With Carpal Tunnel Syndome
Comparison of Short-term Effect of the Kinesiotaping and Night Splinting in Patients With Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) which is defined as a symptomatic compression neuropathy of the median nerve at the level of the wrist.
Different types of splints are used for improving the function and decreasing the pain intensity and symptoms in the rehabilitation of patients with CTS.
However effectiveness of treatment by taping has never been investigated in physiotherapy and rehabilitation.
The aim of this study was to compare the short-term effect of conventional physiotherapy only, and also kinesio taping and night splinting in patients with CTS.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Carpal tunnel syndrome (CTS) which is defined as a symptomatic compression neuropathy of the median nerve at the level of the wrist.It is considered as the most common disabling neuromuscular condition of the upper extremities.
Night splints are used in conjunction with the conservative intervention to improve the function and decrease the pain intensity and paresthesia in the rehabilitation of patients with carpal tunnel syndrome. However effectiveness of treatment by kinesiotaping has never been investigated.
The aim of this study was to compare the short-term effect of conventional physiotherapy only, and also kinesio taping and night splinting in addition to conventional physiotherapy in the rehabilitation of patients with CTS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey, 06100
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- This study included patients with moderate CTS, confirmed by electroneurographic examination.
- did not recruit any treatment (including physiotherapy or surgical release)
Exclusion Criteria:
- Patients suffer from the thenar muscle atrophy.
- Patients with mild CTS.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Kinesiotaping
A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied. Additionally for this group, kinesiotaping will be applied by using carpal tunnel technique including button hole and I band technique of space correction; and with 25-50% tension in center of tape over dorsal carpal tunnel at the end of the each session. Patients will request to keep kinesiotaping at nights throughout the study. |
A total of 20 sessions physiotherapy sessions including hot pack, ultrasound, kinesiotaping and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.times
per day 3sets of ten repetitions) will be applied.
|
|
EXPERIMENTAL: Night splinting
A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied. Additionally, night splinting will be advised. Patients will request to keep their splints at nights throughout the study. |
A total of 20 sessions physiotherapy sessions including hot pack, ultrasound, night splinting and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.
|
|
EXPERIMENTAL: Control group
A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied.
|
A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional impairment
Time Frame: functional impairment will be recorded at baseline and 4-week follow-up
|
functional impairment will be assessed by using Boston Carpal Tunnel Questionnaire.
The score consisted of two sub-scales; The Symptom Severity Scale including 11 questions and The Functional Capacity Scale including 8 questions.
Each scale score is calculated by the average values of the questions.
The scores vary between "1-point" to "5-point".
High score indicates severe symptoms and impaired functional capacity.
|
functional impairment will be recorded at baseline and 4-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: change from baseline to 4-week follow-up will be recorded
|
pain intensity will be assessed by using Visual Analog Scale at rest, activity and at night. All patients were asked to mark their pain level that corresponds to their pain intensity on the line between "0=no pain" and "100=the worst pain imaginable". |
change from baseline to 4-week follow-up will be recorded
|
|
paresthesia
Time Frame: change from baseline to 4-week follow-up will be recorded
|
Paresthesia will be assessed by using Visual Analog Scale at rest, activity and at night. All patients were asked to mark their paresthesia level that corresponds to their paresthesia intensity on the line between "0=no paresthesia" and "100=the worst paresthesia imaginable". |
change from baseline to 4-week follow-up will be recorded
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEK 12/57
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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