Back to resultsEffect of Kinesiotaping and Night Splinting in Patients With Carpal Tunnel Syndome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesiotaping
Night Splinting
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, night splinting, kinesiotaping, physiotherapy and rehabilitation
Eligibility Criteria
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.
Sites / Locations
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Kinesiotaping
Night splinting
Control group
Arm Description
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 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 and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied.
Outcomes
Primary Outcome Measures
functional impairment
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.
Secondary Outcome Measures
pain intensity
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".
paresthesia
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".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04993703
Brief Title
Effect of Kinesiotaping and Night Splinting in Patients With Carpal Tunnel Syndome
Official Title
Comparison of Short-term Effect of the Kinesiotaping and Night Splinting in Patients With Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
February 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe 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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel syndrome, night splinting, kinesiotaping, physiotherapy and rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kinesiotaping
Arm Type
Experimental
Arm Description
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.
Arm Title
Night splinting
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Kinesiotaping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Night Splinting
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
functional impairment
Description
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.
Time Frame
functional impairment will be recorded at baseline and 4-week follow-up
Secondary Outcome Measure Information:
Title
pain intensity
Description
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".
Time Frame
change from baseline to 4-week follow-up will be recorded
Title
paresthesia
Description
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".
Time Frame
change from baseline to 4-week follow-up will be recorded
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Kinesiotaping and Night Splinting in Patients With Carpal Tunnel Syndome
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