- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02233660
The Role of the Cervical Spine in Carpal Tunnel Syndrome
March 14, 2016 updated by: César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
Changes in Function, Cervical Range of Motion and Pinch Grip Force After Physical Therapy in Carpal Tunnel Syndrome: A Randomized Clinical Trial
This randomized clinical trial will investigate changes in hand function, active cervical range of motion and pinch grip force after the application of physical therapy in women with carpal tunnel syndrome (CTS).
The purpose of this study is to compare changes in function, cervical range of motion and pinch grip force induced after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up.
The hypothesis is that manual therapy is more effective for increasing cervical range of motion and pinch grip force, but similarly effective for improving function, than surgical treatment in women with CTS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is some evidence suggesting that CTS is associated with restricted cervical range of motion and deficits in pinch grip force.
In fact, restricted cervical range of motion and deficits in pinch grip force seems to be independent of electro-diagnostic findings.
These findings would be associated with the proposed "double crush syndrome" theory.
However no longitudinal studies have been conducted.
Further it has been demonstrated that hand function is associated to deficits in these outcomes.
Since previous studies support the use of physical therapy and surgical interventions for the management of function in these patients, the aim of this study is to conduct a randomized clinical trial to determine if changes in hand function are related to changes in active cervical range of motion and pinch grip force after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or endoscopic surgery in women with CTS.
Study Type
Interventional
Enrollment (Actual)
100
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
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Madrid
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Alcorcon, Madrid, Spain, 28922
- Hospital Universitario Fundacion Alcorcon
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Alcorcon, Madrid, Spain, 28922
- Universidad Rey Juan Carlos
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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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pain and paresthesia in the median nerve distribution
- Positive Tinel sign,
- Positive Phalen sign,
- Symptoms had to have persisted for at least 6 months
- Deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy
Exclusion Criteria:
- Any sensory/motor deficit related to the ulnar or radial nerve;
- Older than 65 years of age;
- Previous surgical intervention, steroid injections or physical therapy intervention
- Multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
- History of neck, shoulder, or upper limb trauma (whiplash);
- History of any systemic disease causing CTS (eg, diabetes mellitus or thyroid disease);
- History of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);
- Pregnancy
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: Physical Therapy Group.
The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.
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The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.
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Active Comparator: Surgical Group
The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
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The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in hand function between baseline and follow-up periods
Time Frame: Baseline and 1, 3, 6 and 12 months after the intervention
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The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function.
This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day.
Each question is answered on a 5-point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity.
In the current study the score of the functional status scale of this questionnaire will be used as the main outcome.
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Baseline and 1, 3, 6 and 12 months after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in active cervical range of motion between baseline and follow-up periods
Time Frame: Baseline and 1, 3, 6 and 12 months after the intervention
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A cervical range of motion (CROM) device will be used to assess cervical range of motion in a single direction: flexion, extension, lateral flexion toward or away from the side of the CTS, and rotation toward or away from the side of the CTS.
For patients with unilateral symptoms, sides are classified as affected or unaffected whereas in those with bilateral symptoms, the most painful side will be considered as the affected side and the less painful side as the unaffected side.
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Baseline and 1, 3, 6 and 12 months after the intervention
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Changes in pinch grip force between baseline and follow-up periods
Time Frame: Baseline and 1, 3, 6 and 12 months after the intervention
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Pinch grip force between the tip of the thumb with the tip of the index or the little finger will be measured with a pinch grip dynamometer
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Baseline and 1, 3, 6 and 12 months after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
September 3, 2014
First Submitted That Met QC Criteria
September 3, 2014
First Posted (Estimate)
September 8, 2014
Study Record Updates
Last Update Posted (Estimate)
March 15, 2016
Last Update Submitted That Met QC Criteria
March 14, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUFA PI -12/0023
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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