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Trial record 2 of 212 for:    Carpal Tunnel Syndrome

Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02534493
Recruitment Status : Completed
First Posted : August 27, 2015
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Pressure Profile Systems, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: Carpal Tunnel Tissue Manipulation Device (CTMD) Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome
Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: Carpal Tunnel Medical Device (CTMD)
Carpal Tunnel Tissue Manipulation Device (CTMD)
Device: Carpal Tunnel Tissue Manipulation Device (CTMD)
This piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece for a duration of 2-14 hours.
Other Name: Wrist-Aid




Primary Outcome Measures :
  1. Change in SSS of the BCTQ at 28 Days vs Baseline [ Time Frame: 28 days ]
    The primary efficacy variable is the decrease in Symptom Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ). The SSS is a patient-reported measure of the severity of the patient's symptoms caused by carpal tunnel syndrome, on a scale of 1 (no symptoms) to 5 (worst symptoms).


Secondary Outcome Measures :
  1. Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline [ Time Frame: 2 months ]
    The secondary efficacy variable is the decrease in Symptoms Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ) obtained 2 months after the 28-day CTMD treatment period compared to the Baseline SSS score.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534493


Locations
United States, California
Mission Pain and Spine
Mission Viejo, California, United States, 92691
Sponsors and Collaborators
Pressure Profile Systems, Inc.
Investigators
Principal Investigator: Frank J. King, M.D. Mission Pain and Spine

Responsible Party: Pressure Profile Systems, Inc.
ClinicalTrials.gov Identifier: NCT02534493     History of Changes
Other Study ID Numbers: PPS-CTMD-15-001
First Posted: August 27, 2015    Key Record Dates
Results First Posted: December 2, 2017
Last Update Posted: December 2, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries