Clinical Study
A clinical study for patients suffering from carpal tunnel syndrome is currently being carried out in India at a renowned accredited centre for clinical research.
The study is entitled ‘A Prospective, Randomized, Controlled Arm Study to Evaluate the Effectiveness of CarpaStretch® device as a Non-surgical Treatment in Patients with Carpal Tunnel Syndrome.”
This study was approved by the Institutional Ethics committee, and initiated in March 2015.
So far, 45 patients suffering from carpal tunnel syndrome have been enrolled into the study. On obtaining informed consent from eligible patients, they are randomized to either receive the CarpaStretch® device or a standard of care (i.e. a splint along with medication) for one year.
A few patients have completed six months in the study. In November 2015, a pro tem review of the data was conducted.
Interim Report
The review highlights the following (CarpaStretch® compared to conventional therapy):
- Nerve conduction tests have shown exceptional results with a decrease in the severity of carpal tunnel symptoms of most of the patients.
- Phalen's and Tinel's tests performed for assessment of pain and paraesthesia have reported a significant improvement in the symptoms.
- Patients have reported an improvement in the symptoms and functional status through the Boston carpal tunnel syndrome questionnaire.
- Feedback was obtained from patients by an independent team wherein they reported improved overall satisfaction, ease of wearing the device and no discomfort with use of device.
Draft Final Clinical Report
Status 12/2016 - Evaluation after 6 month
CarpaStretch® demonstrates high potential in treating Carpal Tunnel Syndrome
- Statistically significant improvement seen in the Phalen's and Tinel's test in patients using CarpaStretch® as compared to splint at 6 months.
- NCV results have shown a better improvement in the sensory study in patients using CarpaStretch® as compared to splint at 6 months.
- Patients have reported a statistically significant improvement in the symptoms through Boston CTS Questionnaire after 3 months.
