Carpal Tunnel Syndrome
Conditions
Brief summary
Interventional study to evaluate efficacy and safety of an active splint.
Interventions
DEVICECTR device (tradename named Xtend)
Non invasive active splint
Sponsors
Yuinvent Innovations Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female patients, above 40 years of age. * Able to understand and sign informed consent * Pain associated with mild to moderate carpal tunnel syndrome in a single wrist * Numbness and tingling in the median nerve distribution * Nocturnal Numbness * Weakness and/or atrophy of the thenar musculature * Demonstrate positive Phalen's Test of the affected extremity * Demonstrate positive Tinel's Test of the affected extremity * Sensory impairment defined as a loss of 2-point discrimination * Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome
Exclusion criteria
• Currently receiving treatment for carpal tunnel syndrome * History of surgical carpal tunnel release * Pregnancy * Diabetes not controlled by medication * Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy * Thoracic outlet syndrome * Compromised skin integrity * Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in pain score | 10 weeks | Reduction in NRS reported pain score |
Countries
Israel
Contacts
Primary ContactOleg Dulcart, PHd
Outcome results
None listed