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Effectiveness of Bagasse Night Wrist Splint vs. Prefabricated Wrist Support for Conservative Treatment of Carpal Tunnel Syndrome: A Randomized Controlled Trial Comparing Clinical Outcomes

Comparison clinical outcomes between bagasse night wrist splint versus prefabricated wrist support for conservative treatment in carpal tunnel syndrome: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231106001
Enrollment
68
Registered
2023-11-06
Start date
2024-03-04
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A wrist splint designed for patients experiencing mild to moderate symptoms of carpal tunnel syndrome, which can be recycled. Bagasse, Wrist splint, Carpal tunnel syndrome

Interventions

Bagasse wrist splint is to be worn continuously from 20:00 to 08:00 the following day, for a minimum of 6 hours per day. It should be removed in the morning before commencing regular daily activities.
Active Comparator Device,Active Comparator Device
Bagasse Night Wrist Splint,Prefabricated wrist support

Sponsors

Research and International Relations Division, Faculty of Medicine, Srinakharinwirot University
Lead Sponsor
BIODEGRADABLE PACKAGING FOR ENVIRONMENT CO.,LTD.
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with carpal tunnel syndrome, exhibiting symptoms and signs consistent with the condition, such as experiencing pain or numbness along the median nerve, and showing positive results in physical examinations like Phalen's maneuver, Tinel's sign, or the Median nerve compression test.

Exclusion criteria

Exclusion criteria: 1. Patients with underlying conditions such as diabetes, arthritis, pregnancy, low thyroid hormone levels, kidney disease, and multiple abnormal peripheral nerve conditions. 2. Patients who have previously been treated by wrist surgery or received steroid injections in the wrist. 3. Patients with a history of wrist injuries. 4. Patients with severe and clinically assessed median nerve compression in the wrist, as determined by an experienced orthopedic specialist, characterized by muscle weakness or atrophy in the thumb muscles.

Design outcomes

Primary

MeasureTime frame
Function after treatment at 2 weeks and 6 weeks after treatment Thai version Boston questionnaire

Secondary

MeasureTime frame
Pain at 2 weeks and 6 weeks after treatment Visual analog scale,pinch strength at 2 weeks and 6 weeks after treatment Pinch dynamometers,Compliance at 2 weeks and 6 weeks after treatment measurement from record book,adverse event during treatment any complaint by the patients during visit

Countries

Thailand

Contacts

Public ContactVisit Rungsinaporn

Srinakharinwirot university

moo779@hotmail.com0816285362

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026