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Non-invasive CTS Device Clinical Trial

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ClinicalTrials.gov Identifier: NCT03498287
Recruitment Status : Active, not recruiting
First Posted : April 13, 2018
Last Update Posted : December 2, 2019
Sponsor:
Collaborators:
The Cleveland Clinic
Mission Pain and Spine
Kaiser Permanente
Information provided by (Responsible Party):
Pressure Profile Systems, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: Study Device Device: Sham Device Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 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 : May 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: Study Device
Small, non-invasive, stiff patch for the wrist
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).

Sham Comparator: Sham Device
Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 24 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


Information from the National Library of Medicine

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


Locations
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United States, California
Mission Pain & Spine
Mission Viejo, California, United States, 92691
South Bay Medical Center
Torrance, California, United States, 90710
United States, Ohio
Cleveland Clinic (Lerner Research Institute)
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Pressure Profile Systems, Inc.
The Cleveland Clinic
Mission Pain and Spine
Kaiser Permanente
Investigators
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Study Director: Jae Son, PhD Pressure Profile Systems

Additional Information:
Publications:
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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: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
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