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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03243227
Other study ID # 47/2016/2256
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date September 1, 2019

Study information

Verified date September 2019
Source University of Jordan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Carpal tunnel syndrome CTS is the most common peripheral neuropathy seen in clinic. It results in marked functional limitations of patients. Most patients undergo surgical release which places a heavy burden on health system. Neurodynamic exercise is claimed to be an effective physiotherapy treatment for these patients. It is a practical and complications-free treatment which can be used as a home exercise program. This study aims to investigate the effect of median nerve gliding exercise on symptoms severity and functional limitation in CTS patients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date September 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Neurodynamic techniques
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.
Exercise therapy
AROM exercise stretching exercise strengthening exercise 4 sessions

Locations

Country Name City State
Jordan The University of Jordan Amman

Sponsors (1)

Lead Sponsor Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Boston Carpal Tunnel Questionnaire score 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
Secondary The Disabilities of the Arm, Shoulder and Hand (DASH) Score 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 Baseline, 1 month, 6 months
Secondary Pain severity scale subjective rating of pain severity is specified by patient as a number from 0-10. the higher the number the greater level of pain Baseline,1 month , 6 months
Secondary Wrist ROM Range of movement of the wrist joint is measured using universal goniometer. All wrist joint movements will be measured actively and passively. Baseline, 1 month , 6 months
Secondary Grip strength Hand grip strength is measured using a hand held dynamometer device. Reading is taken in pounds. Baseline, 1 month, 6 months
Secondary Surgery whether or not the patient decided to undergo median nerve decompression surgery 6 months
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