Health Condition 1: null- Idiopathic Mild or Moderate Carpal Tunnel Syndrome
Conditions
Interventions
Intervention1: Carpa Stretch: This device comprises at least two adhesive elements which are provided with a skin compatible, self-adhesive coat on the side of the part which is in direct contact with
Sponsors
ConInvent Co Carpa Stretch
Jehangir Clinical Development Centre
Eligibility
Inclusion criteria
Inclusion criteria: Males or females in the age 18- 55 years (both inclusive). Diagnosed with idiopathic mild or moderate Carpal Tunnel Syndrome by Nerve Conduction Velocity Test performed within 30 days of screening visit. Must be willing to comply with all study requirements. Must be able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: Any previous surgery on the affected wrist. Patients having wasting of thenar muscle. Clinical suspicion of local or systemic sepsis or infection. Trauma to the affected hand requiring surgery or immobilization in the previous 12 months. Any inter-current illnesses including, but not limited to: Poorly controlled thyroid disease. Poorly controlled diabetes mellitus. Vibration- induced neuropathy. Inflammatory disease. Suspected complex neurological conditions. Any other severe medical illness which in opinion of the Investigator precludes trial participation. Pregnant or lactating females. Allergy to any splint material. Known abuse of drugs or alcohol. Currently participating or had participated in other interventional study in last 1 month prior to screening. Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behaviour, inability to attend study visits required by the protocol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Nerve Conduction test results in intervention group as compared to control group.Timepoint: Baseline, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in overall satisfaction. Timepoint: Baseline, 3, 6, 9 and 12 months;Change in quality of life.Timepoint: Baseline, 3, 6, 9 and 12 months;Delay or prevention of surgery.Timepoint: Within 12 months time period;Improvement in Provocation tests (Phalenâ??s and Tinel). Timepoint: Baseline, 3, 6, 9 and 12 months;Improvement in symptom severity and functional status.Timepoint: Baseline, 3, 6, 9 and 12 months | — |
Countries
India
Contacts
Public ContactDr Vijay Malshikare
Jehangir Clinical Development Centre
Outcome results
None listed