NCT06214286

Brief Summary

PURPOSE: To investigate the effect of adding Shock wave therapy to kinesio taping on relieving carpal tunnel syndrome symptoms in physical therapist females. BACKGROUND: shockwave therapy is a popular non-invasive therapeutic modality in the medical field for the treatment of numerous musculoskeletal disorders. Shockwaves can generate interstitial and extracellular responses, producing many beneficial effects such as: pain relief, vascularization, protein biosynthesis, cell proliferation, neuro and chondroprotection, and destruction of calcium deposits in musculoskeletal structures. shockwave combined with conventional physiotherapy is an effective noninvasive treatment for mild-to-moderate carpal tunnel syndrome that produces greater and longer-lasting results than conventional physiotherapy alone HYPOTHESES: Adding Shock wave therapy to kinesio taping has positive effects on carpal tunnel syndrome in physical therapist females. RESEARCH QUESTION: Does adding Shock wave therapy to kinesio taping has positive effects on carpal tunnel syndrome in physical therapist females?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

December 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

December 11, 2023

Last Update Submit

August 7, 2024

Conditions

Keywords

ShockwaveCarpel tunnel

Outcome Measures

Primary Outcomes (1)

  • Pain Visual Analog Scale

    It is a self reported outcome which is a 10 cm line with zero at one end indicating no pain and 10 at the other end indicating maximum pain. Patient will be asked to mark the current pain on the scale and the distance from the starting point (0) will be measured

    1 and 12 week

Secondary Outcomes (4)

  • Numbness Visual Analog Scale

    1 and 12 week

  • Boston Carpal Tunnel Questionnaire

    1 and 12 week

  • handgrip strength

    1 and 12 week

  • electrodiagnostic study for median nerve

    1 and 12 week

Study Arms (2)

Shockwave

EXPERIMENTAL

One group received shock wave therapy with the conventional physical therapy program including kinesio taping

Device: ShockwaveOther: Kinesio tapingOther: conventional physical therapy

conventional

ACTIVE COMPARATOR

conventional physical therapy program including kinesio taping without shock wave therapy

Other: Kinesio tapingOther: conventional physical therapy

Interventions

ShockwaveDEVICE

Shockwave therapy

Shockwave

Kinesio taping application

Shockwaveconventional

conventional physical therapy

Shockwaveconventional

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged between 20 and 40 years
  • diagnosed as having mild and moderate carpal tunnel syndrome through clinical parameters and nerve conduction studies (NCSs),

You may not qualify if:

  • \- Having any systemic diseases such as renal failure, peptic ulcer, diabetes mellitus, hypothyroidism, coagulopathy, inflammatory rheumatic disease, having a cardiac pacemaker, cervical radiculopathy, polyneuropathy or brachial plexopathy, systemic corticosteroid use, fracture or trauma history in the forearm and wrist pregnancy and lactation, having received a carpal tunnel syndrome surgery, thoracic outlet syndrome or severe carpal tunnel syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University in Cairo (BUC)

Cairo, 12311, Egypt

RECRUITING

Study Officials

  • Omnya samy Abdallah Ghoneim, PhD

    Department of Physical Therapy for Pediatrics and Pediatric Surgery, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

    STUDY CHAIR
  • Mina Magdy Wahba, PhD

    Department of Physical Therapy for Orthpedics, Suez University

    PRINCIPAL INVESTIGATOR
  • Fatma Said Zidan Hamed, PhD

    Department of Physical therapy for Neuromuscular Disorders & its Surgery, Faculty of Physical Therapy, Badr University in Cairo, Egypt

    STUDY CHAIR
  • Hanaa Samir Mohamed Abd el fatah, PhD

    Faculty of Physical therapy, Modern University for Technology and Information, Egypt.

    STUDY DIRECTOR
  • Doha Hamed Moustafa Al-Afify, PhD

    Basic Sciences Department, Faculty of Physical Therapy, Badr University in Cairo, Egypt

    STUDY CHAIR
  • Doaa Saeed

    Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Badr University in Cairo, Cairo, Egypt

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A total of 100 females patients ( two groups each group 50 females) who were diagnosed as having mild or moderate carpal tunnel syndrome were included in the study. One group received shock wave therapy with the conventional physical therapy program including kinesio taping, the second group received the conventional physical therapy program including kinesio taping without shock wave therapy. The patients were evaluated using a Visual Analog Scale-pain, a Visual Analog Scale-numbness, the Boston Symptom Severity Scale, the Boston Functional Status Scale, and handgrip strength tests and Nerve conduction study before treatment 1 and 12 wks after the treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 11, 2023

First Posted

January 19, 2024

Study Start

March 20, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations