Extra Corporeal Shock Wave Versus Kinesio Tape in Carpal Tunnel Syndrome

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05405647
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 7.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Device: Shock wave Therapy; Device: kinesio tape	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 .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)
• Primary Purpose: Treatment
• Official Title: Extra Corporeal Shock Wave Versus Kinesio Tape in the Treatment of Carpal Tunnel Syndrome for Post Menopausal Women
• Actual Study Start Date: Jul 1, 2021
• Actual Primary Completion Date: Jan 29, 2022
• Actual Study Completion Date: Jan 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: shock wave therapy 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.	Device: Shock wave Therapy; 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.; Device: kinesio tape; kinesio tape application on the affected wrist for 3 days and then one day off and then another 3 days each week for 6weeks.
Experimental: kinesio tape 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.	Device: Shock wave Therapy; 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.; Device: kinesio tape; kinesio tape application on the affected wrist for 3 days and then one day off and then another 3 days each week for 6weeks.

Outcome Measures

Primary Outcome Measures

1. Computerized electromyography [6 weeks]

   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

1. Boston carpal tunnel questionnaire [6 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghada Ebrahim Elrefaye	Giza		Egypt	12613

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ghada Ebrahim El Refaye, assistant professor department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt, Woman's Health University Hospital, Egypt
• ClinicalTrials.gov Identifier: NCT05405647
• Other Study ID Numbers: Cairo Un115
• First Posted: Jun 6, 2022
• Last Update Posted: Jun 7, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ghada Ebrahim El Refaye, assistant professor department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt, Woman's Health University Hospital, Egypt: shock wave; kinesio tape; carpal tunnel syndrome
• Additional relevant MeSH terms: Carpal Tunnel Syndrome; Syndrome

Study Results

No Results Posted as of Jun 7, 2022