Non-invasive CTS Device Clinical Trial
Status: | Recruiting |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 21 - 65 |
Updated: | 12/22/2018 |
Start Date: | October 10, 2018 |
End Date: | June 2019 |
Contact: | Pauline Luong, ME |
Email: | info@carpaltunneltrial.com |
Phone: | 425-298-3775 |
Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome
Sham-controlled, multi-center and remote patient-centered randomized controlled clinical
trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in
reducing symptoms of carpal tunnel syndrome (CTS). Daily wear of the study device is expected
to significantly reduce symptom severity (evaluated by the Boston Carpal Tunnel
Questionnaire) in mild to severe CTS-diagnosed patients. Subjects are randomized into the
active device group or sham group for 8 weeks, then followed for 12 weeks post-treatment.
trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in
reducing symptoms of carpal tunnel syndrome (CTS). Daily wear of the study device is expected
to significantly reduce symptom severity (evaluated by the Boston Carpal Tunnel
Questionnaire) in mild to severe CTS-diagnosed patients. Subjects are randomized into the
active device group or sham group for 8 weeks, then followed for 12 weeks post-treatment.
It is hypothesized that daily wear of the study device will result in significant
improvements in patient-reported symptom severity. It is also hypothesized that the effects
from active study device treatment will be significantly greater than effects from sham
treatment. In both cases, it is hypothesized that improvements will be sustained
post-treatment.
This study is designed as a randomized, double-blind, sham-controlled, two-arm trial
consisting of an eight-week treatment period (active study device or sham), followed by one
required follow-up four weeks later (at week 12).
There are two study groups: the active device group receiving the active study device and the
sham group receiving a non-active sham device. Subjects will be informed that they have a
50:50 chance of receiving treatment or a sham. They will also be informed that if they
receive sham device, they will be offered the active device 4 weeks into the post-treatment
period. However, all subjects will not know what treatment they are on until the conclusion
of the trial.
improvements in patient-reported symptom severity. It is also hypothesized that the effects
from active study device treatment will be significantly greater than effects from sham
treatment. In both cases, it is hypothesized that improvements will be sustained
post-treatment.
This study is designed as a randomized, double-blind, sham-controlled, two-arm trial
consisting of an eight-week treatment period (active study device or sham), followed by one
required follow-up four weeks later (at week 12).
There are two study groups: the active device group receiving the active study device and the
sham group receiving a non-active sham device. Subjects will be informed that they have a
50:50 chance of receiving treatment or a sham. They will also be informed that if they
receive sham device, they will be offered the active device 4 weeks into the post-treatment
period. However, all subjects will not know what treatment they are on until the conclusion
of the trial.
Inclusion Criteria:
1. Clinically diagnosed with mild to severe carpal tunnel syndrome (CTS)
2. CTS diagnosis confirmed by a nerve conduction study (NCS) performed within the past 12
months OR at enrollment/baseline visit
1. CTS severity determined via AANEM criteria 13
2. Bilateral CTS accepted (worse wrist via NCS and/or BCTQ is designated as the
study wrist)
3. BCTQ SSS > 2
4. Reliable access to and ability to use Internet, Wi-Fi, or mobile data through
computers, mobile devices, laptops, and/or tablets
5. Willing to abstain from any other treatment or therapies for CTS throughout the study
6. Ability to read and write English, or has a reliable person to assist with reading and
writing English
Exclusion Criteria:
1. Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies,
ulnar nerve neuropathies)
2. Double crush syndrome
3. Cervical stenosis
4. Brachial plexopathy
5. Wrist fractures or cysts
6. Prior wrist surgeries, especially carpal tunnel release surgery
7. Injection of corticosteroid/cortisone into the wrist or hand within the past 6 months
8. Thyroid disease
9. Rheumatoid arthritis
10. Diabetes
11. Systemic diseases
12. Connective tissue diseases
13. Fibromyalgia or chronic pain syndrome
14. Diabetic neuropathy
15. BMI > 40
16. Participation in other research studies or clinical trials currently or within the
past 2 weeks.
To assess eligibility, visit: carpaltunneltrial.com
We found this trial at
3
sites
Mission Viejo, California 92691
Principal Investigator: Frank J King, MD
Phone: 949-916-8100
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Cleveland, Ohio 44195
Principal Investigator: Zong-Ming Li, PhD
Phone: 216-445-2282
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