Clinical trial NCT03498287: Non-invasive CTS Device Clinical Trial
Official title: Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
carpal tunnel
CTS
musculoskeletal disorder
peripheral neuropathy
repetitive stress injury
non-invasive device
non-significant risk
medical device
wrist pain
Lead sponsor: Pressure Profile Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
name: Mission Pain and Spine
name: Kaiser Permanente
First posted: 2018-04-13
Enrollment: 88
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: BCTQ SSS at 8 Weeks vs Baseline
timeFrame: baseline and 8 weeks post-Baseline
Secondary outcomes:
measure: BCTQ SSS
timeFrame: 8-weeks post-Baseline and 12 weeks post-Baseline
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Mission Pain & Spine
state: California
city: Torrance
country: United States
facility: South Bay Medical Center
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic (Lerner Research Institute)
state: Ohio
Study officials:
affiliation: Pressure Profile Systems
name: Jae Son, PhD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1186/1471-2474-7-78.