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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Jordan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
Other: Exercise therapy
AROM exercise stretching exercise strengthening exercise 4 sessions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jordan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 47/2016/2256

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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