- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07074509
- Original Trial
Effectiveness of Manual Therapy and Extracoropral Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
Comparative Study of Effectiveness of Manual Therapy and Extracoropral Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
Study Overview
Status
Intervention / Treatment
Detailed Description
Carpal tunnel syndrome (CTS), the most common peripheral neuropathy in the upper limb, occurs due to the entrapment of the median nerve at the wrist. Treatment options for CTS consist of wrist splints, physical modalities, local corticosteroid injections, and surgical release.
Extracorporeal shockwave therapy (ESWT) is a noninvasive technique that uses single-pulse acoustic waves. These pulses are generated outside the body and focused on a specific part of the body.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both sexes.
- Patients with mild and moderate carpal tunnel syndrome (CTS).
Exclusion Criteria:
- Severe cases of CTS.
- History of carpal tunnel release surgery.
- Steroid injection in carpal tunnel in the past 6 months.
- Cases of thoracic outlet syndrome and cervical radiculopathy.
- Pregnant females.
- Systemic rheumatic diseases such as rheumatoid arthritis.
- Hypothyroidism.
- Patients with bleeding tendency.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
Patients were treated by manual therapy in the form of nerve gliding, soft tissue release, and carpal bone mobilization, three sessions per week for 4weeks.
|
Patients were treated by manual therapy in the form of nerve gliding, soft tissue release, and carpal bone mobilization, three sessions per week for 4weeks.
|
|
Experimental: Group 2
Patients were treated by extracorporeal shock wave therapy.
4 sessions, one week apart, 2000 pulses per session, intensity 1.6 mj/mm, and frequency 8Hz.
|
Patients were treated by extracorporeal shock wave therapy.
4 sessions, one week apart, 2000 pulses per session, intensity 1.6 mj/mm, and frequency 8Hz.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue scale
Time Frame: 3 months post-procedure
|
A visual analogue scale (VAS) via 11-point numerical pain rating scale (0=no pain to 10=maximum pain) was used to assess the current level of pain and hand discomfort
|
3 months post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Boston Questionnaire
Time Frame: 3 months post-procedure
|
The Boston Questionnaire is a standardized, patient-based outcome measure of symptom severity and functional status in patients with carpal tunnel syndrome.
The questionnaire including two parts, namely the symptom severity scales (SSS) and the functional status scales (FSS), is considered a standard tool to evaluate the patients with carpal tunnel syndrome (CTS).
The SSS contains 11 questions on different symptoms of hand and FSS comprises of 5 questions assessing the difficulty in performing selected activities.
The response to each question was scored from one (mildest) to five (most severe) points.
The overall scores for SSS and FSS were calculated as the score sum of all questions.
|
3 months post-procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36208/12/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpal Tunnel Syndrome
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Stanford UniversityMayo Clinic; National Institute of Arthritis and Musculoskeletal and Skin Diseases... and other collaboratorsCompletedCarpal Tunnel Syndrome | Carpal Tunnel | Carpal Tunnel Syndrome Bilateral | Carpal Tunnel Syndrome Left | Carpal Tunnel Syndrome RightUnited States
-
Issa, Abdulhamid Sayed, M.D.CompletedCarpal Tunnel Syndrome | CTS | Carpal Tunnel Release | Carpal Tunnel Surgery | Carpal Tunnel Transverse ApproachSyrian Arab Republic
-
Kuopio University HospitalUniversity of Eastern FinlandNot yet recruitingCarpal Tunnel Syndrome (CTS) | Carpal Tunnel SurgeryFinland
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University of Sao Paulo General HospitalRecruitingCarpal Tunnel Syndrome (CTS) | Carpal Tunnel SurgeryBrazil
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Maasstad HospitalRecruitingCarpal Tunnel Syndrome (CTS) | Lacertus SyndromeNetherlands
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Ankara UniversityNot yet recruitingCarpal Tunnel Syndrome (CTS)Turkey (Türkiye)
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Afyonkarahisar Health Sciences UniversityRecruitingCarpal Tunnel Syndrome (CTS)Turkey (Türkiye)
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Assiut UniversityNot yet recruiting
-
Sohag UniversityNot yet recruitingCarpal Tunnel Syndrome (CTS)Egypt
-
ElsanRecruiting
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