A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical function in subjects previously diagnosed with mild to severe carpal tunnel syndrome (CTS).

A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical function in subjects previously diagnosed with mild to severe carpal tunnel syndrome.

Inclusion Criteria

1. male or female, ages 21-65 and in good general health;

2. subject diagnosed with mild to severe carpal tunnel syndrome (CTS) (AANEM criteria for CTS)

   • mild CTS: prolonged distal sensory latency with ± decreased sensory amplitude
   • moderate CTS: abnormal median sensory latency with prolongation of the distal motor latency
   • severe CTS: prolonged motor and sensory distal peak latencies either with a low or absent SNAP or CMAP

3. bilateral CTS accepted (either mild, moderate or severe CTS bilaterally), however, more involved wrist (via NCS) used as "study" wrist;

4. Boston Carpal Tunnel Questionnaire (BCTQ) Symptoms Score ≥ 2;

5. women of childbearing potential must be willing to practice effective contraception for the duration of the study (i.e., abstinence, condoms or diaphragm with spermicide, IUD, or birth control pills [BCP]);

   NOTE: Females on birth control pills (BCP) must be stable on the same type and dose of pill for at least three months prior to entering the study and must not change the type of BCP or dosing regimen during the study. Those who have discontinued using BCPs in favor of another form of contraception must have discontinued BCP usage at least 3 months prior to the start of the study.

6. women of child bearing potential must have a negative urine pregnancy test at the Baseline Visit (Visit 1, Day 0) and must not be lactating; and

7. willingness to follow protocol requirements, including signing an informed consent and health information release forms, attending routine follow-up visits and completing questionnaires.

Exclusion Criteria

1. known sensitivity to adhesives or glue;
2. history of diabetes mellitus;
3. history of thyroid disease;
4. history of prior wrist fractures;
5. known to be easily bruised (hematoma);
6. concurrent use of blood thinners;
7. history of connective tissue disease;
8. diagnosed with superimposed peripheral neuropathy;
9. history of cervical radiculopathy;
10. diagnosed with purely ulnar paresthesias;
11. history of ulnar neuropathy;
12. history of brachial plexopathy;
13. diagnosed with pronator teres syndrome;
14. history of polyneuropathy;
15. uncontrolled systemic disease;
16. history of any mass, tumor, severe trauma or deformity of the hand or wrist;
17. previous surgery of the hand or wrist;
18. history of prior carpal tunnel release;
19. current use of any splinting or bracing medical device for CTS;
20. currently taking any medication therapy that could cause a focal or generalized neuropathy (e.g., antiepileptics, statins, chemotherapeutic or antiarrhythmic);
21. history of any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results;
22. concomitant use of systemic medication(s) or therapy that may have a substantial effect on CTS condition, unless such medication(s) or therapy has/have been used for a minimum of 3 months prior to study enrollment, is/are expected to remain constant throughout the course of the study and is/are considered necessary for a subjects' welfare;
23. females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception;
24. inability to give informed consent; and
25. concurrent participation or prior participation in any investigation drug or device study within the last 30 days prior to the Baseline Visit (Visit 1).

Only the affected wrist was treated in participants with unilateral CTS. Both wrists were treated on participants with bilateral CTS but only the worse wrist (higher severity via NCS or higher BCTQ SSS score) was used for analysis.

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.

This study was an open-label pilot study with no placebo. Subjects were not allowed other CTS treatments except for occasional painkillers. Daily home activities not controlled. One subject had wrist arthritis. One subject had unconfirmed arthritis.

open label