- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03243227
Effectiveness of Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Design: Two groups randomized controlled trial
- Participants: 50 subjects diagnosed with CTS will be recruited from JUH physical medicine and rehabilitation department, diagnosis will be confirmed by a physician clinically and using nerve conduction test. Subjects will be randomized into treatment and control groups.
- Procedures: Participants will be recruited from the physical medicine department at JUH and the diagnosis and initial assessment will be performed by a physician. Baseline outcomes will be measured by an experienced physiotherapist.
Treatment Group: Neurodynamics evaluation and treatment will be provided by an experienced physiotherapist. Each treatment session involves both manual therapy and median nerve mobilization exercise following the neurodynamics concept. Four 60 minutes sessions over a period of four weeks will be performed for each patient. Median nerve mobilization exercise will be continued as home exercise program and will be monitored by the treating physiotherapist using exercise diary.
Control group: four sessions of exercise will be given to participants. CTS standard exercise brochure will be given for the patients to follow over 4 weeks. The brochure will include wrist joint strengthening, stretching and AROM exercise.
Outcomes will be measured at the end of the 4 weeks treatment, 6 weeks and 6 months post treatment.
• Data analysis: Microsoft Excel and SPSS will be used for data entry and analysis.
Descriptive analysis: All obtained data will be tabulated, means, standard deviations and differences will be measured.
Inferential analysis: Two way repeated measure ANOVA will be used to measure differences between the groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Amman, Jordan, 11942
- The university of Jordan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Confirmed CTS diagnosis
Exclusion Criteria:
Previous trauma or surgery involving the upper extremities known neurological condition pregnancy history of radiating neck or back pain in the previous 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neurodynamic techniques
4 sessions of Neurodynamics treatment will be provided by an experienced physiotherapist.
It will include manual therapy, median nerve gliding exercise, median nerve tension exercise.
patients will continue the exercises as home exercise program during and after the treatment period.
|
4 sessions of Neurodynamics treatment will be provided by and experienced physiotherapist.
It will include manual therapy, median nerve gliding exercise, median nerve tension exercise.
patients will continue the exercises as home exercise program during and after the treatment period.
|
Active Comparator: Exercise
Exercise therapy 4 sessions of exercise treatment will be provided by an experienced physiotherapist.
It will include active range of motion, stretching, and strengthening exercise.
patients will be given a brochure to continue the exercises as home exercise program during and after the treatment period.
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AROM exercise stretching exercise strengthening exercise 4 sessions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Boston Carpal Tunnel Questionnaire score
Time Frame: Baseline, 1 month, 6 months
|
BCTS is a patient-based outcome measure used for patients with CTS.
It includes two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale.
Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.
|
Baseline, 1 month, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: Baseline, 1 month, 6 months
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DASH is a patient-based outcome measure used to assess function in patients with arm or hand pain. it includes two components: the disability/symptom
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Baseline, 1 month, 6 months
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Pain severity scale
Time Frame: Baseline,1 month , 6 months
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subjective rating of pain severity is specified by patient as a number from 0-10. the higher the number the greater level of pain
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Baseline,1 month , 6 months
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Wrist ROM
Time Frame: Baseline, 1 month , 6 months
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Range of movement of the wrist joint is measured using universal goniometer.
All wrist joint movements will be measured actively and passively.
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Baseline, 1 month , 6 months
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Grip strength
Time Frame: Baseline, 1 month, 6 months
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Hand grip strength is measured using a hand held dynamometer device.
Reading is taken in pounds.
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Baseline, 1 month, 6 months
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Surgery
Time Frame: 6 months
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whether or not the patient decided to undergo median nerve decompression surgery
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hayat Hamzeh, MSC, Lecturer
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
- 47/2016/2256
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.
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