Non-invasive CTS Device Clinical Trial

• Sponsor: Pressure Profile Systems, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03498287
• Collaborator: The Cleveland Clinic (Other), Mission Pain and Spine (Other), Kaiser Permanente (Other)
• Enrollment: 88
• Locations: 3
• Arms: 2
• Actual Duration (Months): 18.4
• Patients Per Site: 29.3
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Sham-controlled, multi-center and remote patient-centered randomized controlled clinical trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in reducing symptoms of carpal tunnel syndrome (CTS). Daily wear of the study device is expected to significantly reduce symptom severity (evaluated by the Boston Carpal Tunnel Questionnaire) in mild to severe CTS-diagnosed patients. Subjects are randomized into the active device group or sham group for 8 weeks, then followed for 12 weeks post-treatment.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Device: Study Device; Device: Sham Device	N/A

Detailed Description

It is hypothesized that daily wear of the study device will result in significant improvements in patient-reported symptom severity. It is also hypothesized that the effects from active study device treatment will be significantly greater than effects from sham treatment. In both cases, it is hypothesized that improvements will be sustained post-treatment.

This study is designed as a randomized, double-blind, sham-controlled, two-arm trial consisting of an eight-week treatment period (active study device or sham), followed by one required follow-up four weeks later (at week 12).

There are two study groups: the active device group receiving the active study device and the sham group receiving a non-active sham device. Subjects will be informed that they have a 50:50 chance of receiving treatment or a sham. They will also be informed that if they receive sham device, they will be offered the active device 4 weeks into the post-treatment period. However, all subjects will not know what treatment they are on until the conclusion of the trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome
• Actual Study Start Date: Oct 10, 2018
• Actual Primary Completion Date: Feb 28, 2020
• Actual Study Completion Date: Apr 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Device Small, non-invasive, stiff patch for the wrist	Device: 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 Comparator: Sham Device Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.	Device: 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 are given the real study device at the end of the Post-Treatment/Follow-up Phase.

Outcome Measures

Primary Outcome Measures

1. BCTQ SSS at 8 Weeks vs Baseline [baseline and 8 weeks post-Baseline]

   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).

Secondary Outcome Measures

1. BCTQ SSS [8-weeks post-Baseline and 12 weeks post-Baseline]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Clinically diagnosed with mild to severe carpal tunnel syndrome (CTS)

2. CTS diagnosis confirmed by a nerve conduction study (NCS) performed within the past 24 months OR at enrollment/baseline visit

3. CTS severity determined via AANEM criteria 13

4. Bilateral CTS accepted (worse wrist via NCS and/or BCTQ is designated as the study wrist)

5. BCTQ SSS > 2

6. Reliable access to and ability to use Internet, Wi-Fi, or mobile data through computers, mobile devices, laptops, and/or tablets

7. Willing to abstain from any other treatment or therapies for CTS throughout the study

8. Ability to read and write English, or has a reliable person to assist with reading and writing English

Exclusion Criteria:

1. Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies, ulnar nerve neuropathies)

2. Double crush syndrome

3. Cervical stenosis

4. Brachial plexopathy

5. Wrist fractures or cysts

6. Prior wrist surgeries, especially carpal tunnel release surgery

7. Injection of corticosteroid/cortisone into the wrist or hand within the past 6 months

8. Thyroid disease

9. Rheumatoid arthritis

10. Diabetes

11. Systemic diseases

12. Connective tissue diseases

13. Fibromyalgia or chronic pain syndrome

14. Diabetic neuropathy

15. BMI > 40

16. Participation in other research studies or clinical trials currently or within the past 2 weeks.

To assess eligibility, visit: carpaltunneltrial.com

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mission Pain & Spine	Mission Viejo	California	United States	92691
2	South Bay Medical Center	Torrance	California	United States	90710
3	Cleveland Clinic (Lerner Research Institute)	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Pressure Profile Systems, Inc.
• The Cleveland Clinic
• Mission Pain and Spine
• Kaiser Permanente

Investigators

• Study Director: Jae Son, PhD, Pressure Profile Systems

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 20, 2018

More Information

Additional Information:

• Practice Parameter for Electrodiagnostic Studies in Carpal Tunnel Syndrome: Summary Statement.

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 Posted: Apr 13, 2018
• Last Update Posted: Jul 14, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Pressure Profile Systems, Inc.: carpal tunnel syndrome; carpal tunnel; CTS; musculoskeletal disorder; peripheral neuropathy; repetitive stress injury; non-invasive device; non-significant risk; medical device; wrist pain
• Additional relevant MeSH terms: Carpal Tunnel Syndrome; Syndrome

Study Results

Participant Flow

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

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 Participants	42	38	80
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	42 100%	37 97.4%	79 98.8%
>=65 years	0 0%	1 2.6%	1 1.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.6 (11.7)	48.6 (9.9)	48.6 (10.8)
Sex/Gender, Customized (Count of Participants)
Female	34 81%	27 71.1%	61 76.3%
Male	8 19%	10 26.3%	18 22.5%
Decline to Answer	0 0%	1 2.6%	1 1.3%
Ethnicity (NIH/OMB) (Count of 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 28.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	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%
Black or African American	2 4.8%	2 5.3%	4 5%
White	32 76.2%	30 78.9%	62 77.5%
More than one race	3 7.1%	1 2.6%	4 5%
Unknown or Not Reported	3 7.1%	3 7.9%	6 7.5%
Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Score (SSS) (units on a 1-5 Likert scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a 1-5 Likert scale]	2.78 (.58)	2.96 (.42)	2.87 (.52)
BCTQ Functional Severity Score (FSS) (units on a 1-5 Likert scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a 1-5 Likert scale]	2.21 (.72)	2.39 (.70)	2.30 (.71)

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.
Measure Participants	42	38
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.
Measure Participants	42	38
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/38 (0%)
Serious Adverse Events
	Study Device		Sham Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Study Device		Sham Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/42 (4.8%)		2/38 (5.3%)
Injury, poisoning and procedural complications
Rash, redness, or sore under study device	2/42 (4.8%)		2/38 (5.3%)

Limitations/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.

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.