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Effectiveness of Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Neurodynamic techniques
Exercise therapy
Sponsored by
University of Jordan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, neurodynamics, median nerve gliding exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Jordan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neurodynamic techniques

Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Wrist ROM
Range of movement of the wrist joint is measured using universal goniometer. All wrist joint movements will be measured actively and passively.
Grip strength
Hand grip strength is measured using a hand held dynamometer device. Reading is taken in pounds.
Surgery
whether or not the patient decided to undergo median nerve decompression surgery

Full Information

First Posted
August 3, 2017
Last Updated
September 19, 2019
Sponsor
University of Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT03243227
Brief Title
Effectiveness of Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome
Official Title
Effectiveness of Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel syndrome, neurodynamics, median nerve gliding exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurodynamic techniques
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neurodynamic techniques
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
AROM exercise stretching exercise strengthening exercise 4 sessions
Primary Outcome Measure Information:
Title
Change in Boston Carpal Tunnel Questionnaire score
Description
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.
Time Frame
Baseline, 1 month, 6 months
Secondary Outcome Measure Information:
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Description
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
Time Frame
Baseline, 1 month, 6 months
Title
Pain severity scale
Description
subjective rating of pain severity is specified by patient as a number from 0-10. the higher the number the greater level of pain
Time Frame
Baseline,1 month , 6 months
Title
Wrist ROM
Description
Range of movement of the wrist joint is measured using universal goniometer. All wrist joint movements will be measured actively and passively.
Time Frame
Baseline, 1 month , 6 months
Title
Grip strength
Description
Hand grip strength is measured using a hand held dynamometer device. Reading is taken in pounds.
Time Frame
Baseline, 1 month, 6 months
Title
Surgery
Description
whether or not the patient decided to undergo median nerve decompression surgery
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayat Hamzeh, MSC
Organizational Affiliation
Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Jordan
City
Amman
ZIP/Postal Code
11942
Country
Jordan

12. IPD Sharing Statement

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Effectiveness of Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome

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