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Completed

NCT Number: NCT03498287

Non-invasive CTS Device Clinical Trial

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Musculoskeletal Diseases Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mission Pain & Spine, Mission Viejo, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically diagnosed with mild to severe carpal tunnel syndrome (CTS)
  • CTS diagnosis confirmed by a nerve conduction study (NCS) performed within the past 24 months OR at enrollment/baseline visit
  • CTS severity determined via AANEM criteria 13
  • Bilateral CTS accepted (worse wrist via NCS and/or BCTQ is designated as the study wrist)
  • BCTQ SSS > 2
  • Reliable access to and ability to use Internet, Wi-Fi, or mobile data through computers, mobile devices, laptops, and/or tablets
  • Willing to abstain from any other treatment or therapies for CTS throughout the study
  • Ability to read and write English, or has a reliable person to assist with reading and writing English

Exclusion criteria

  • Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies, ulnar nerve neuropathies)
  • Double crush syndrome
  • Cervical stenosis
  • Brachial plexopathy
  • Wrist fractures or cysts
  • Prior wrist surgeries, especially carpal tunnel release surgery
  • Injection of corticosteroid/cortisone into the wrist or hand within the past 6 months
  • Thyroid disease
  • Rheumatoid arthritis
  • Diabetes
  • Systemic diseases
  • Connective tissue diseases
  • Fibromyalgia or chronic pain syndrome
  • Diabetic neuropathy
  • BMI > 40
  • Participation in other research studies or clinical trials currently or within the past 2 weeks.

To assess eligibility, visit: carpaltunneltrial.com

Treatment and study plan

Study Device

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

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.

Primary outcomes

  1. BCTQ SSS at 8 Weeks vs Baseline

    Time frame: 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 outcomes

  1. BCTQ SSS

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Pressure Profile Systems, Inc.

Industry

Collaborators

  • Kaiser Permanente
  • Mission Pain and Spine
  • The Cleveland Clinic

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2018
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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