NCT05405647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

June 1, 2022

Last Update Submit

June 4, 2022

Conditions

Keywords

shock wavekinesio tapecarpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

    6 weeks

Secondary Outcomes (1)

  • Boston carpal tunnel questionnaire

    6 weeks

Study Arms (2)

shock wave therapy

EXPERIMENTAL

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 TherapyDevice: kinesio tape

kinesio tape

EXPERIMENTAL

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 TherapyDevice: kinesio tape

Interventions

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 tapeshock wave therapy

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

kinesio tapeshock wave therapy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghada Ebrahim Elrefaye

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Extracorporeal Shockwave TherapyAthletic Tape

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationBandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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 .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

July 1, 2021

Primary Completion

January 29, 2022

Study Completion

January 30, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations