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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.

Tracking Information
First Submitted Date  ICMJE April 8, 2018
First Posted Date  ICMJE April 13, 2018
Last Update Posted Date December 2, 2019
Actual Study Start Date  ICMJE October 10, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03498287 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2018)
Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) [ Time Frame: Post-treatment timepoints (12, 18, and 20 weeks) ]
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)
Current Other Pre-specified Outcome Measures
 (submitted: April 8, 2018)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Non-invasive CTS Device Clinical Trial
Official Title  ICMJE Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • Experimental: Study Device
    Small, non-invasive, stiff patch for the wrist
    Intervention: Device: Study Device
  • Sham Comparator: Sham Device
    Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.
    Intervention: Device: Sham Device
Publications * Leite JC, Jerosch-Herold C, Song F. A systematic review of the psychometric properties of the Boston Carpal Tunnel Questionnaire. BMC Musculoskelet Disord. 2006 Oct 20;7:78. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 27, 2019)
81
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2018)
102
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03498287
Other Study ID Numbers  ICMJE PPS-CTS-SBIR2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pressure Profile Systems, Inc.
Study Sponsor  ICMJE Pressure Profile Systems, Inc.
Collaborators  ICMJE
  • The Cleveland Clinic
  • Mission Pain and Spine
  • Kaiser Permanente
Investigators  ICMJE
Study Director: Jae Son, PhD Pressure Profile Systems
PRS Account Pressure Profile Systems, Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP