Trial Outcomes & Findings for Non-invasive CTS Device Clinical Trial (NCT NCT03498287)

Last Updated: 2020-07-14

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

baseline and 8 weeks post-Baseline

Results posted on

2020-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Study Device 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)	Sham Device 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.
Overall Study STARTED	45	43
Overall Study COMPLETED	42	38
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Device 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)	Sham Device 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.
Overall Study Withdrawal by Subject	3	0
Overall Study Protocol Violation	0	4
Overall Study Adverse Event	0	1

Baseline Characteristics

80 per-protocol patients analyzed vs total number enrolled

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Device n=42 Participants 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).	Sham Device n=38 Participants 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 n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	37 Participants n=7 Participants	79 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	48.6 years STANDARD_DEVIATION 11.7 • n=5 Participants	48.6 years STANDARD_DEVIATION 9.9 • n=7 Participants	48.6 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex/Gender, Customized Female	34 Participants n=5 Participants	27 Participants n=7 Participants	61 Participants n=5 Participants
Sex/Gender, Customized Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Sex/Gender, Customized Decline to Answer	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	30 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Score (SSS)	2.78 units on a 1-5 Likert scale STANDARD_DEVIATION .58 • n=5 Participants • 80 per-protocol patients analyzed vs total number enrolled	2.96 units on a 1-5 Likert scale STANDARD_DEVIATION .42 • n=7 Participants • 80 per-protocol patients analyzed vs total number enrolled	2.87 units on a 1-5 Likert scale STANDARD_DEVIATION .52 • n=5 Participants • 80 per-protocol patients analyzed vs total number enrolled
BCTQ Functional Severity Score (FSS)	2.21 units on a 1-5 Likert scale STANDARD_DEVIATION .72 • n=5 Participants • 80 per-protocol patients analyzed vs total number enrolled	2.39 units on a 1-5 Likert scale STANDARD_DEVIATION .70 • n=7 Participants • 80 per-protocol patients analyzed vs total number enrolled	2.30 units on a 1-5 Likert scale STANDARD_DEVIATION .71 • n=5 Participants • 80 per-protocol patients analyzed vs total number enrolled

PRIMARY outcome

Timeframe: baseline and 8 weeks post-Baseline

Population: Per-protocol population (patients that completed at least up to the first post-treatment follow-up (Week 12))

Outcome measures

Outcome measures
Measure	Study Device n=42 Participants 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).	Sham Device n=38 Participants 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.
BCTQ SSS at 8 Weeks vs Baseline Average SSS	2.16 score on a scale Standard Deviation .65	2.32 score on a scale Standard Deviation .70
BCTQ SSS at 8 Weeks vs Baseline Average Change in SSS	-0.62 score on a scale Standard Deviation 0.69	-0.64 score on a scale Standard Deviation 0.62

SECONDARY outcome

Timeframe: 8-weeks post-Baseline and 12 weeks post-Baseline

Population: Per-protocol population (patients that completed at least up to the first post-treatment follow-up (Week 12))

Outcome measures

Outcome measures
Measure	Study Device n=42 Participants 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).	Sham Device n=38 Participants 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.
BCTQ SSS Average SSS @12 weeks	2.24 score on a scale Standard Deviation .70	2.44 score on a scale Standard Deviation .68
BCTQ SSS Average Change in SSS between 12 and 8 weeks	0.08 score on a scale Standard Deviation 0.48	0.12 score on a scale Standard Deviation 0.40

Adverse Events

Study Device

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham Device

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Device n=42 participants at risk 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).	Sham Device n=38 participants at risk 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.
Injury, poisoning and procedural complications Rash, redness, or sore under study device	4.8% 2/42 • Patient participation duration: 5-6 months 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.	5.3% 2/38 • Patient participation duration: 5-6 months 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.

Additional Information

Clinical Trials Manager

Pressure Profile Systems

Phone: 310.641.8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER