Non-invasive CTS Device Clinical Trial

Carpal Tunnel Syndrome Clinical Trial

Official title:

Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498287
• Other study ID #: PPS-CTS-SBIR2
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: April 21, 2020

Study information

• Verified date: June 2020
• Source: Pressure Profile Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 21, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

1. CTS severity determined via AANEM criteria 13

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

3. BCTQ SSS > 2

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

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

6. 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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic (Lerner Research Institute)	Cleveland	Ohio
United States	Mission Pain & Spine	Mission Viejo	California
United States	South Bay Medical Center	Torrance	California

Sponsors (4)

Lead Sponsor	Collaborator
Pressure Profile Systems, Inc.	Kaiser Permanente, Mission Pain and Spine, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCTQ SSS at 8 Weeks vs 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).	baseline and 8 weeks post-Baseline
Secondary	BCTQ SSS	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).	8-weeks post-Baseline and 12 weeks post-Baseline

External Links

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