Carpal Tunnel Syndromes Clinical Trial
Official title:
Changes in Function, Cervical Range of Motion and Pinch Grip Force After Physical Therapy in Carpal Tunnel Syndrome: A Randomized Clinical Trial
| Verified date | March 2016 |
| Source | Universidad Rey Juan Carlos |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Comité Ético de Investigación Clínica |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario Fundación Alcorcon | Alcorcon | Madrid |
| Spain | Universidad Rey Juan Carlos | Alcorcon | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad Rey Juan Carlos | Hospital Universitario Fundación Alcorcón |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in hand function between baseline and follow-up periods | 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. | Baseline and 1, 3, 6 and 12 months after the intervention | Yes |
| Secondary | Changes in active cervical range of motion between baseline and follow-up periods | 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. | Baseline and 1, 3, 6 and 12 months after the intervention | Yes |
| Secondary | Changes in pinch grip force between baseline and follow-up periods | 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 | Baseline and 1, 3, 6 and 12 months after the intervention | Yes |