Carpal Tunnel SyndromeNCT02534493
Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome
A study testing Carpal Tunnel Tissue Manipulation Device (CTMD) in people with Carpal Tunnel Syndrome, run by Pressure Profile Systems, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Carpal Tunnel Tissue Manipulation Device (CTMD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female, ages 21-65 and in good general health;
- 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
- bilateral CTS accepted (either mild, moderate or severe CTS bilaterally), however, more involved wrist (via NCS) used as "study" wrist;
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- Boston Carpal Tunnel Questionnaire (BCTQ) Symptoms Score ≥ 2;
- 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.
- 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
- willingness to follow protocol requirements, including signing an informed consent and health information release forms, attending routine follow-up visits and completing questionnaires.
Who cannot join
- known sensitivity to adhesives or glue;
- history of diabetes mellitus;
- history of thyroid disease;
- history of prior wrist fractures;
- known to be easily bruised (hematoma);
- concurrent use of blood thinners;
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- history of connective tissue disease;
- diagnosed with superimposed peripheral neuropathy;
- history of cervical radiculopathy;
- diagnosed with purely ulnar paresthesias;
- history of ulnar neuropathy;
- history of brachial plexopathy;
- diagnosed with pronator teres syndrome;
- history of polyneuropathy;
- uncontrolled systemic disease;
- history of any mass, tumor, severe trauma or deformity of the hand or wrist;
- previous surgery of the hand or wrist;
- history of prior carpal tunnel release;
- current use of any splinting or bracing medical device for CTS;
- currently taking any medication therapy that could cause a focal or generalized neuropathy (e.g., antiepileptics, statins, chemotherapeutic or antiarrhythmic);
- 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;
- 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;
- females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception;
- inability to give informed consent; and
- concurrent participation or prior participation in any investigation drug or device study within the last 30 days prior to the Baseline Visit (Visit 1).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mission Pain and Spine
Mission Viejo, California, 92691
About this study
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).
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Carpal Tunnel Tissue Manipulation Device (CTMD)
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal Tunnel Tissue Manipulation Device (CTMD)Device
Also called Wrist-Aid
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.
| Study group | Role | What they receive |
|---|---|---|
| Carpal Tunnel Medical Device (CTMD) | Experimental | Carpal Tunnel Tissue Manipulation Device (CTMD) Receives: Device: Carpal Tunnel Tissue Manipulation Device (CTMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SSS of the BCTQ at 28 Days vs Baseline
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).
Measured: 28 days
Secondary outcomes (1)
Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pressure Profile Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank J. King, M.D., Principal investigator, Mission Pain and Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534493
- Sponsor's protocol ID
- PPS-CTMD-15-001
- Status last verified
- Oct 2017
- First submitted
- 25 Mar 2015
- Last updated
- 2 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02534493
- Acronym / sponsor ID
- PPS-CTMD-15-001
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Pressure Profile Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Posted 2 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carpal Tunnel Medical Device (CTMD) | Experimental | Device: Carpal Tunnel Tissue Manipulation Device (CTMD)Carpal Tunnel Tissue Manipulation Device (CTMD) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- male or female, ages 21-65 and in good general health;
- subject diagnosed with mild to severe carpal tunnel syndrome (CTS) (AANEM criteria for CTS)
- bilateral CTS accepted (either mild, moderate or severe CTS bilaterally), however, more involved wrist (via NCS) used as "study" wrist;
- Boston Carpal Tunnel Questionnaire (BCTQ) Symptoms Score ≥ 2;
- 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]);
Key exclusion criteria (25 listed)
- known sensitivity to adhesives or glue;
- history of diabetes mellitus;
- history of thyroid disease;
- history of prior wrist fractures;
- known to be easily bruised (hematoma);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carpal Tunnel Tissue Manipulation Device (CTMD)Also: Wrist-AidThis 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. | Device | Carpal Tunnel Medical Device (CTMD) |
Primary outcome
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).
1 secondary outcome
Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Carpal Tunnel Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank J. King, M.D. principal investigator
Mission Pain and Spine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carpal Tunnel Tissue Manipulation Device (CTMD) in people with Carpal Tunnel Syndrome, run by Pressure Profile Systems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SSS of the BCTQ at 28 Days vs Baseline (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.