Non-invasive CTS Device Clinical Trial

• 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: Pressure Profile Systems, Inc.
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Study Device	Sham Device
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

Baseline Characteristics

Arm/Group Title		Study Device	Sham Device	Total
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
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

Outcome Measures

1. Primary Outcome

Title	BCTQ SSS at 8 Weeks vs Baseline
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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%)
Serious Adverse Events
	Study Device	Sham Device
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/42 (0.00%)	0/38 (0.00%)
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

Limitations and Caveats

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.

More Information

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

• Name/Title: Clinical Trials Manager
• Organization: Pressure Profile Systems
• Phone: 310.641.8100
• EMail: research@wrist-aid.com

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.

• 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