Trial Outcomes & Findings for Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome (NCT NCT02534493)

Last Updated: 2017-12-02

Results Overview

The primary efficacy variable is the decrease in Symptom Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ). The SSS is a patient-reported measure of the severity of the patient's symptoms caused by carpal tunnel syndrome, on a scale of 1 (no symptoms) to 5 (worst symptoms).

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

28 days

Results posted on

2017-12-02

Participant Flow

Participants were only enrolled if a nerve conduction study (NCS) was performed at the enrollment visit or within the past 6 months, electrodiagnostically confirming the presence of mild to severe CTS.

Unit of analysis: per affected wrist

Participant milestones

Participant milestones
Measure	Carpal Tunnel Medical Device (CTMD) The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period. If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
Overall Study STARTED	13 19
Overall Study COMPLETED	11 15
Overall Study NOT COMPLETED	2 4

Reasons for withdrawal

Reasons for withdrawal
Measure	Carpal Tunnel Medical Device (CTMD) The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period. If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carpal Tunnel Medical Device (CTMD) n=11 Participants The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period. If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	51.4 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Bilaterality Unilateral CTS	7 Participants n=5 Participants
Bilaterality Bilateral CTS	4 Participants n=5 Participants
Severity Mild	3 Participants n=5 Participants
Severity Moderate	4 Participants n=5 Participants
Severity Severe	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Primary outcome measures were analyzed for unilateral and bilateral subjects combined, but measures were analyzed for unilateral and bilateral subjects separately as well.

Outcome measures

Outcome measures
Measure	Unilateral+Bilateral n=11 Participants The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Unilateral subjects wore the CTMD on the single affected wrist. Bilateral subjects wore the CTMD on both wrists, but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.	Unilateral Only n=7 Participants The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Unilateral subjects wore the CTMD on the single affected wrist.	Bilateral Only n=4 Participants The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Bilateral subjects wore the CTMD on both wrists, but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
Change in SSS of the BCTQ at 28 Days vs Baseline	0.59 point decrease in SSS Standard Deviation 0.68	0.93 point decrease in SSS Standard Deviation 0.52	.00 point decrease in SSS Standard Deviation 0.50

SECONDARY outcome

Timeframe: 2 months

The secondary efficacy variable is the decrease in Symptoms Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ) obtained 2 months after the 28-day CTMD treatment period compared to the Baseline SSS score.

Outcome measures

Outcome measures
Measure	Unilateral+Bilateral n=11 Participants The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Unilateral subjects wore the CTMD on the single affected wrist. Bilateral subjects wore the CTMD on both wrists, but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.	Unilateral Only n=7 Participants The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Unilateral subjects wore the CTMD on the single affected wrist.	Bilateral Only n=4 Participants The CTMD was worn for a duration of 8-10 hours daily over the treatment period. Bilateral subjects wore the CTMD on both wrists, but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline	0.79 point decrease in SSS Standard Deviation 0.74	1.20 point decrease in SSS Standard Deviation 0.53	0.09 point decrease in SSS Standard Deviation 0.41

Adverse Events

Carpal Tunnel Medical Device (CTMD)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Carpal Tunnel Medical Device (CTMD) n=11 participants at risk The Carpal Tunnel Tissue Manipulation Device (CTMD) is a piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece. The CTMD is worn for a duration of 8-10 hours daily over the treatment period. If a participant had bilateral CTS, both wrists were treated but only the worst wrist (via NCS and BCTQ SSS score) was analyzed.
Skin and subcutaneous tissue disorders Skin Reddening/Irritation	63.6% 7/11 • 3 months (1 month device wear and 2 months post-treatment) per subject Inclusion of Unanticipated Adverse Device Event (ADE) in addition to SAE, to clarify serious adverse events caused by associated with the device. Adverse events self-reported by subjects and recorded in AE logs.
Product Issues Acute Irritation	18.2% 2/11 • 3 months (1 month device wear and 2 months post-treatment) per subject Inclusion of Unanticipated Adverse Device Event (ADE) in addition to SAE, to clarify serious adverse events caused by associated with the device. Adverse events self-reported by subjects and recorded in AE logs.

Additional Information

Jae Son

Pressure Profile Systems

Phone: 3106418100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place