- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06493617
Does Cervical Mobilization Have an Effect on Hand Function in Patients With Double Crush Syndrome?
July 11, 2024 updated by: Ahmed Alshimy
All Double Crush Syndrome patients were assessed via VAS, BCTQ & Nerve conduction study before and after the treatment program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The patients were classified randomly into two groups, the control group received a standard physical therapy program of nerve glide, hand strengthening exercise and mobilization and the study group they received a cervical mobilization in addition to the standard physical therapy program for 12 sessions.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Menoufia
-
Sadat, Menoufia, Egypt
- Al Ryada University for Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Thirty female patients diagnosed as Double Crush Syndrome based on the clinical diagnostic criteria of the American Academy of Neurology, (American Academy of Neurology 2019).
- Patient ages ranged from 25 to 35 years old. Patient who reported pain, hyperesthesia, and/or paresthesia at the course of median nerve distribution and upper limb.
- A Nerve Conduction Study (NCS) evidence of peripheral entrapment of median nerve at level of carpal bone "Carpal tunnel Syndrome" with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less and with sensory peak latency > 3.6 ms and recordable and with motor distal latency >4.4 ms and less than 6.5ms.
Exclusion Criteria:
- Patients had Systemic disease causes double Crush Syndrome as rheumatoid arthritis (RA), thyroid disease, Diabetes mellitus (DM), Pregnant women, Patients with concomitant neurological disease as peripheral neuropathy, Patients with history of wrist surgery, fracture, or carpal tunnel injection in the last two weeks before the study, Patients who have wasting of the thenar muscles, Patients with previous surgery for CTS.
- Patients with complete conduction block on EDX or previous regular exposure to hand-held vibrating tools, Patients with Nerve Conduction Study with motor distal latency > 6.5 ms.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
received a standard physical therapy program of nerve glide, hand strengthening exercise and mobilization
|
tendon gliding exercises, median nerve gliding exercise, strengthening exercises for 60 minutes
|
|
Experimental: Study Group
received a cervical mobilization in addition to the standard physical therapy program for 12 sessions
|
tendon gliding exercises, median nerve gliding exercise, strengthening exercises for 60 minutes
The technique is used to mobilize a specific cervical or upper thoracic segment (C2-C3 through T3-T4) in a posterior to anterior direction.
The therapist gently applies pressure in an anteroposterior direction in the plane of the facet joint to assess mobility, resistance, end feel, and pain provocation.
Gentle oscillations can be used to either inhibit pain (grades I and II) or restore motion (grades III and IV).
Slight variations in depth and direction of force can be used to optimize the therapeutic effects of this technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nerve conduction study
Time Frame: 4 weeks
|
Used to assess sensory and motor fibers of median nerve to determine the improvement in nerve capacity and hand function
|
4 weeks
|
|
Visual analogue scale
Time Frame: 4 weeks
|
Used to assess degree of pain
|
4 weeks
|
|
Boston carpal tunnel syndrome questionnaire
Time Frame: 4 weeks
|
Used to assess patients' functional ability and symptoms severity
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2022
Primary Completion (Actual)
August 5, 2023
Study Completion (Actual)
January 8, 2024
Study Registration Dates
First Submitted
July 2, 2024
First Submitted That Met QC Criteria
July 2, 2024
First Posted (Actual)
July 10, 2024
Study Record Updates
Last Update Posted (Actual)
July 12, 2024
Last Update Submitted That Met QC Criteria
July 11, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003943
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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-
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