Non-invasive CTS Device Clinical Trial
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03498287 |
Recruitment Status :
Completed
First Posted : April 13, 2018
Results First Posted : July 14, 2020
Last Update Posted : July 14, 2020
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Carpal Tunnel Syndrome |
Interventions |
Device: Study Device Device: Sham Device |
Enrollment | 88 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Study Device | Sham Device |
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Small, non-invasive, orthodontic arch with adhesive applied to the wrist 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). (1 wrist per participant) |
Device that looks like the Study Device but modified to prevent or remove the main mechanism of action. 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). (1 wrist per participant) *Note: participants in the sham group were given the real study device at the end of the Post-Treatment/Follow-up Phase. |
Period Title: Overall Study | ||
Started | 45 | 43 |
Completed | 42 | 38 |
Not Completed | 3 | 5 |
Reason Not Completed | ||
Withdrawal by Subject | 3 | 0 |
Protocol Violation | 0 | 4 |
Adverse Event | 0 | 1 |
Arm/Group Title | Study Device | Sham Device | Total | |
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Small, non-invasive, orthodontic arch with adhesive applied to the wrist 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 that looks like the Study Device but modified to prevent or remove the main mechanism of action. 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 were given the real study device at the end of the Post-Treatment/Follow-up Phase. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 42 | 38 | 80 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 42 participants | 38 participants | 80 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
42 100.0%
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37 97.4%
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79 98.8%
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>=65 years |
0 0.0%
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1 2.6%
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1 1.3%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 42 participants | 38 participants | 80 participants | |
48.6 (11.7) | 48.6 (9.9) | 48.6 (10.8) | ||
Sex/Gender, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 42 participants | 38 participants | 80 participants |
Female |
34 81.0%
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27 71.1%
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61 76.3%
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Male |
8 19.0%
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10 26.3%
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18 22.5%
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Decline to Answer |
0 0.0%
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1 2.6%
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1 1.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 42 participants | 38 participants | 80 participants | |
Hispanic or Latino |
7 16.7%
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3 7.9%
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10 12.5%
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Not Hispanic or Latino |
25 59.5%
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22 57.9%
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47 58.8%
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Unknown or Not Reported |
10 23.8%
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13 34.2%
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23 28.7%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 42 participants | 38 participants | 80 participants | |
American Indian or Alaska Native |
0 0.0%
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1 2.6%
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1 1.3%
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Asian |
2 4.8%
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1 2.6%
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3 3.8%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
2 4.8%
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2 5.3%
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4 5.0%
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White |
32 76.2%
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30 78.9%
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62 77.5%
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More than one race |
3 7.1%
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1 2.6%
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4 5.0%
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Unknown or Not Reported |
3 7.1%
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3 7.9%
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6 7.5%
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Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Score (SSS)
[1] [2] Mean (Standard Deviation) Unit of measure: Units on a 1-5 Likert scale |
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Number Analyzed | 42 participants | 38 participants | 80 participants | |
2.78 (.58) | 2.96 (.42) | 2.87 (.52) | ||
[1]
Measure Description: enrollment/baseline symptom severity score on the 1-5 Likert scale with 1 being no symptoms and 5 being worst symptoms
[2]
Measure Analysis Population Description: 80 per-protocol patients analyzed vs total number enrolled
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BCTQ Functional Severity Score (FSS)
[1] [2] Mean (Standard Deviation) Unit of measure: Units on a 1-5 Likert scale |
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Number Analyzed | 42 participants | 38 participants | 80 participants | |
2.21 (.72) | 2.39 (.70) | 2.30 (.71) | ||
[1]
Measure Description: enrollment/baseline functional severity score on the 1-5 Likert scale with 1 being no symptoms and 5 being worst symptoms
[2]
Measure Analysis Population Description: 80 per-protocol patients analyzed vs total number enrolled
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Authorship will reflect joint cooperation between PPS and participating PI(s). Authorship responsibilities should be established prior to the writing of any manuscript.
No individual publications are allowed unless agreed upon, reviewed, and approved by the Sponsor before submission and/or publication. No individual publications are allowed prior to the completion of a final report for the study.
Name/Title: | Clinical Trials Manager |
Organization: | Pressure Profile Systems |
Phone: | 310.641.8100 |
EMail: | research@wrist-aid.com |
Responsible Party: | Pressure Profile Systems, Inc. |
ClinicalTrials.gov Identifier: | NCT03498287 |
Other Study ID Numbers: |
PPS-CTS-SBIR2 |
First Submitted: | April 8, 2018 |
First Posted: | April 13, 2018 |
Results First Submitted: | June 8, 2020 |
Results First Posted: | July 14, 2020 |
Last Update Posted: | July 14, 2020 |