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Extra Corporeal Shock Wave Versus Kinesio Tape in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Shock wave Therapy
kinesio tape
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring shock wave, kinesio tape, carpal tunnel syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Accepts Healthy Volunteers

Inclusion Criteria:

  • -Age was ranged from 45 - 55 years old
  • All subjects would not take analgesics by another route during the study.

Exclusion Criteria:

  • Patients had previous carpal tunnel release.
  • Skin over sensitivity of some patients to the tape.

Sites / Locations

  • Ghada Ebrahim Elrefaye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

shock wave therapy

kinesio tape

Arm Description

received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session, and a frequency of 5 Hz., 1 sessions per week for 6 weeks.

kinesio tape application on the affected wrist for 3 days and then one day off and then another 3 days each week for 6 weeks.

Outcomes

Primary Outcome Measures

Computerized electromyography
2 channel version with EMG/NCV/EP system, It was used to measure median motor distal latency (MMDL) before treatment and after 6 weeks of treatment for all patients

Secondary Outcome Measures

Boston carpal tunnel questionnaire
The overall score for the functional-status scale was the mean of the ratings on the 8 daily activities. In this study BCTQ was translated and filled by the therapist

Full Information

First Posted
June 1, 2022
Last Updated
June 4, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05405647
Brief Title
Extra Corporeal Shock Wave Versus Kinesio Tape in Carpal Tunnel Syndrome
Official Title
Extra Corporeal Shock Wave Versus Kinesio Tape in the Treatment of Carpal Tunnel Syndrome for Post Menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 29, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study would be conducted to answer the following question: was there any difference between the effects of Shock wave versus Kinesio Tape in the treatment of carpal tunnel syndrome for post-menopausal women.
Detailed Description
Fifty menopausal women with mild to moderate CTS were selected randomly from outpatient clinic of the physical therapy department of El khazendara general hospital, Age was ranged from 45 - 55 years old. Group A, consisted of 25 patients who received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session. Group B Represented the control group, it consisted of 25 patients who received a program of kinesio tape application on the affected wrist for 3 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
shock wave, kinesio tape, carpal tunnel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Fifty menopausal women with mild to moderate CTS will be selected randomly from outpatient clinic of the physical therapy department of El khazendara general hospital, Shobra to participate in this study,Group A: Represented the study group, it consisted of 25 patients who received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session. Group B: Represented the control group, it consisted of 25 patients who received a program of kinesio tape application on the affected wrist for 3 days .
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
shock wave therapy
Arm Type
Experimental
Arm Description
received a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session, and a frequency of 5 Hz., 1 sessions per week for 6 weeks.
Arm Title
kinesio tape
Arm Type
Experimental
Arm Description
kinesio tape application on the affected wrist for 3 days and then one day off and then another 3 days each week for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Shock wave Therapy
Intervention Description
a program of 6 session of Shock wave Therapy on the affected wrist,5 minute per session and a frequency of 5 Hz., 1 sessions per week for 6 weeks.
Intervention Type
Device
Intervention Name(s)
kinesio tape
Intervention Description
kinesio tape application on the affected wrist for 3 days and then one day off and then another 3 days each week for 6weeks.
Primary Outcome Measure Information:
Title
Computerized electromyography
Description
2 channel version with EMG/NCV/EP system, It was used to measure median motor distal latency (MMDL) before treatment and after 6 weeks of treatment for all patients
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Boston carpal tunnel questionnaire
Description
The overall score for the functional-status scale was the mean of the ratings on the 8 daily activities. In this study BCTQ was translated and filled by the therapist
Time Frame
6 weeks

10. Eligibility

Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: -Age was ranged from 45 - 55 years old All subjects would not take analgesics by another route during the study. Exclusion Criteria: Patients had previous carpal tunnel release. Skin over sensitivity of some patients to the tape.
Facility Information:
Facility Name
Ghada Ebrahim Elrefaye
City
Giza
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Extra Corporeal Shock Wave Versus Kinesio Tape in Carpal Tunnel Syndrome

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