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Non-invasive CTS Device Clinical Trial

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ClinicalTrials.gov Identifier: NCT03498287
Recruitment Status : Completed
First Posted : April 13, 2018
Results First Posted : July 14, 2020
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
The Cleveland Clinic
Mission Pain and Spine
Kaiser Permanente
Information provided by (Responsible Party):
Pressure Profile Systems, Inc.

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 38 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
 100.0%
37
  97.4%
79
  98.8%
>=65 years
0
   0.0%
1
   2.6%
1
   1.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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%
27
  71.1%
61
  76.3%
Male
8
  19.0%
10
  26.3%
18
  22.5%
Decline to Answer
0
   0.0%
1
   2.6%
1
   1.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 38 participants 80 participants
Hispanic or Latino
7
  16.7%
3
   7.9%
10
  12.5%
Not Hispanic or Latino
25
  59.5%
22
  57.9%
47
  58.8%
Unknown or Not Reported
10
  23.8%
13
  34.2%
23
  28.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 38 participants 80 participants
American Indian or Alaska Native
0
   0.0%
1
   2.6%
1
   1.3%
Asian
2
   4.8%
1
   2.6%
3
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   4.8%
2
   5.3%
4
   5.0%
White
32
  76.2%
30
  78.9%
62
  77.5%
More than one race
3
   7.1%
1
   2.6%
4
   5.0%
Unknown or Not Reported
3
   7.1%
3
   7.9%
6
   7.5%
Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Score (SSS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a 1-5 Likert scale
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
BCTQ Functional Severity Score (FSS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a 1-5 Likert scale
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
1.Primary Outcome
Title BCTQ SSS at 8 Weeks vs Baseline
Hide Description The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 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).
Time Frame baseline and 8 weeks post-Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population (patients that completed at least up to the first post-treatment follow-up (Week 12))
Arm/Group Title Study Device Sham Device
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 42 38
Mean (Standard Deviation)
Unit of Measure: score on a scale
Average SSS 2.16  (.65) 2.32  (.70)
Average Change in SSS -0.62  (0.69) -0.64  (0.62)
2.Secondary Outcome
Title BCTQ SSS
Hide Description The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 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).
Time Frame 8-weeks post-Baseline and 12 weeks post-Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population (patients that completed at least up to the first post-treatment follow-up (Week 12))
Arm/Group Title Study Device Sham Device
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 42 38
Mean (Standard Deviation)
Unit of Measure: score on a scale
Average SSS @12 weeks 2.24  (.70) 2.44  (.68)
Average Change in SSS between 12 and 8 weeks 0.08  (0.48) 0.12  (0.40)
Time Frame Patient participation duration: 5-6 months
Adverse Event Reporting Description Device is a non-invasive externally-worn orthotic made of hypoallergenic materials and does not introduce any medications, chemicals, biologics, or electromagnetic energy into the body. Only expected adverse events are related to skin reaction, rash, allergy, discomfort from device wear, and progression of carpal tunnel syndrome.
 
Arm/Group Title Study Device Sham Device
Hide Arm/Group Description

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.

All-Cause Mortality
Study Device Sham Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/38 (0.00%) 
Hide Serious Adverse Events
Study Device Sham Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/38 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Study Device Sham Device
Affected / at Risk (%) Affected / at Risk (%)
Total   2/42 (4.76%)   2/38 (5.26%) 
Injury, poisoning and procedural complications     
Rash, redness, or sore under study device *  2/42 (4.76%)  2/38 (5.26%) 
*
Indicates events were collected by non-systematic assessment
Sham device was not thoroughly tested before the trial. Post-trial testing suggest some mechanical effect that could have influenced the sham group response. Early termination of enrollment reduced the power of the statistical analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Manager
Organization: Pressure Profile Systems
Phone: 310.641.8100
EMail: research@wrist-aid.com
Layout table for additonal information
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