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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02233660 |
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Date of registration:
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03/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Role of the Cervical Spine in Carpal Tunnel Syndrome
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Scientific title:
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Changes in Function, Cervical Range of Motion and Pinch Grip Force After Physical Therapy in Carpal Tunnel Syndrome: A Randomized Clinical Trial |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02233660 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Spain
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Carpal Tunnel Syndromes
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Intervention(s)
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Procedure: Surgical Group
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Other: Physical Therapy Group
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Primary Outcome(s)
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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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Secondary Outcome(s)
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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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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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Secondary ID(s)
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HUFA PI -12/0023
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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