Carpal Tunnel SyndromeNCT03243227
Effectiveness of Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome
A study testing Neurodynamic techniques and Exercise therapy in people with Carpal Tunnel Syndrome, run by University of Jordan at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Neurodynamic techniques and Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jul 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed CTS diagnosis
Who cannot join
- Previous trauma or surgery involving the upper extremities known neurological condition pregnancy history of radiating neck or back pain in the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Neurodynamic techniques, Exercise therapy
- Keywords
- carpal tunnel syndrome, neurodynamics, median nerve gliding exercise
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodynamic techniquesOther
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 therapyOther
AROM exercise stretching exercise strengthening exercise 4 sessions
| Study group | Role | What they receive |
|---|---|---|
| Neurodynamic techniques | Experimental | 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. Receives: Other: Neurodynamic techniques |
| Exercise | Active comparator | 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. Receives: Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 6 months
Secondary outcomes (5)
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
Measured: Baseline, 1 month, 6 months
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
Measured: Baseline,1 month , 6 months
Wrist ROM
Range of movement of the wrist joint is measured using universal goniometer. All wrist joint movements will be measured actively and passively.
Measured: Baseline, 1 month , 6 months
Grip strength
Hand grip strength is measured using a hand held dynamometer device. Reading is taken in pounds.
Measured: Baseline, 1 month, 6 months
Surgery
whether or not the patient decided to undergo median nerve decompression surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayat Hamzeh, University of Jordan
- Investigators
- Hayat Hamzeh, MSC, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243227
- Sponsor's protocol ID
- 47/2016/2256
- Status last verified
- Sep 2019
- First submitted
- 3 Aug 2017
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03243227
- Acronym / sponsor ID
- 47/2016/2256
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, neurodynamics, median nerve gliding exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurodynamic techniques | Experimental | Other: Neurodynamic techniques4 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 | Active comparator | Other: Exercise therapyExercise 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed CTS diagnosis
Key exclusion criteria (1 listed)
- Previous trauma or surgery involving the upper extremities known neurological condition pregnancy history of radiating neck or back pain in the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodynamic techniques4 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. | Other | Neurodynamic techniques |
| Exercise therapyAROM exercise stretching exercise strengthening exercise 4 sessions | Other | Exercise |
Primary outcome
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.
5 secondary outcomes
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: Baseline, 1 month, 6 months
Pain severity scale
Time frame: Baseline,1 month , 6 months
Wrist ROM
Time frame: Baseline, 1 month , 6 months
Grip strength
Time frame: Baseline, 1 month, 6 months
Surgery
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayat Hamzeh, MSC principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodynamic techniques and Exercise therapy in people with Carpal Tunnel Syndrome, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Boston Carpal Tunnel Questionnaire score (time frame: Baseline, 1 month, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.