Non-invasive CTS Device Clinical Trial
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| ClinicalTrials.gov Identifier: NCT03498287 |
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Recruitment Status :
Recruiting
First Posted : April 13, 2018
Last Update Posted : June 12, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Carpal Tunnel Syndrome | Device: Study Device Device: Sham Device | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome |
| Actual Study Start Date : | October 10, 2018 |
| Estimated Primary Completion Date : | November 2019 |
| Estimated Study Completion Date : | January 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Study Device
Small, non-invasive, stiff patch for the wrist
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Device: Study Device
Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). |
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Sham Comparator: Sham Device
Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.
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Device: Sham Device
Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). *Note: participants in the sham group are given the real study device at the end of the Post-Treatment/Follow-up Phase. |
- Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) [ Time Frame: 8 weeks post-Baseline ]11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
- Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) [ Time Frame: Post-treatment timepoint (12 weeks post-Baseline) ]11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
- eDiary Wear Time Response [ Time Frame: Daily for 8 weeks ]Time (duration) and percentage of days device worn as reported by participants in the eDiary
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinically diagnosed with mild to severe carpal tunnel syndrome (CTS)
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CTS diagnosis confirmed by a nerve conduction study (NCS) performed within the past 24 months OR at enrollment/baseline visit
- CTS severity determined via AANEM criteria 13
- Bilateral CTS accepted (worse wrist via NCS and/or BCTQ is designated as the study wrist)
- BCTQ SSS > 2
- Reliable access to and ability to use Internet, Wi-Fi, or mobile data through computers, mobile devices, laptops, and/or tablets
- Willing to abstain from any other treatment or therapies for CTS throughout the study
- Ability to read and write English, or has a reliable person to assist with reading and writing English
Exclusion Criteria:
- Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies, ulnar nerve neuropathies)
- Double crush syndrome
- Cervical stenosis
- Brachial plexopathy
- Wrist fractures or cysts
- Prior wrist surgeries, especially carpal tunnel release surgery
- Injection of corticosteroid/cortisone into the wrist or hand within the past 6 months
- Thyroid disease
- Rheumatoid arthritis
- Diabetes
- Systemic diseases
- Connective tissue diseases
- Fibromyalgia or chronic pain syndrome
- Diabetic neuropathy
- BMI > 40
- Participation in other research studies or clinical trials currently or within the past 2 weeks.
To assess eligibility, visit: carpaltunneltrial.com
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498287
| Contact: Pauline Luong, ME | 425-298-3775 | info@carpaltunneltrial.com | |
| Contact: www.carpaltunneltrial.com |
| United States, California | |
| Mission Pain & Spine | Recruiting |
| Mission Viejo, California, United States, 92691 | |
| Contact: Heather McCormick 949-916-8100 heather@missionpainspine.com | |
| Principal Investigator: Frank J King, MD | |
| South Bay Medical Center | Recruiting |
| Torrance, California, United States, 90710 | |
| Contact: Edna Halilbegovic Edna.X.Halilbegovic@kp.org | |
| Contact: Tiffany Castanon Tiffany.L.Castanon@kp.org | |
| Principal Investigator: David Nguyen, MD | |
| United States, Ohio | |
| Cleveland Clinic (Lerner Research Institute) | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Heather Wojanowski 216-445-2282 WOJANOH@ccf.org | |
| Contact: Nikki Breslaw, RN, BSN 216-476-0174 BRESLAN@ccf.org | |
| Principal Investigator: Zong-Ming Li, PhD | |
| Study Director: | Jae Son, PhD | Pressure Profile Systems |
Additional Information:
Publications:
| Responsible Party: | Pressure Profile Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT03498287 History of Changes |
| Other Study ID Numbers: |
PPS-CTS-SBIR2 |
| First Posted: | April 13, 2018 Key Record Dates |
| Last Update Posted: | June 12, 2019 |
| Last Verified: | June 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | Yes | |
| Device Product Not Approved or Cleared by U.S. FDA: | No | |
| Pediatric Postmarket Surveillance of a Device Product: | No | |
Keywords provided by Pressure Profile Systems, Inc.:
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carpal tunnel syndrome carpal tunnel CTS musculoskeletal disorder peripheral neuropathy |
repetitive stress injury non-invasive device non-significant risk medical device wrist pain |
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome Syndrome Disease Pathologic Processes Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases |
Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries |