Effectiveness of Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome

September 19, 2019 updated by: Hayat Hamzeh, University of Jordan
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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

53

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

      • Amman, Jordan, 11942
        • The university of Jordan

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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: 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.
AROM exercise stretching exercise strengthening exercise 4 sessions

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

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
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
Pain severity scale
Time Frame: Baseline,1 month , 6 months
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
Wrist ROM
Time Frame: Baseline, 1 month , 6 months
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
Grip strength
Time Frame: Baseline, 1 month, 6 months
Hand grip strength is measured using a hand held dynamometer device. Reading is taken in pounds.
Baseline, 1 month, 6 months
Surgery
Time Frame: 6 months
whether or not the patient decided to undergo median nerve decompression surgery
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hayat Hamzeh, MSC, Lecturer

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)

July 1, 2017

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

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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