Carpal Tunnel SyndromeNCT03498287
Non-invasive CTS Device Clinical Trial
A study testing Study Device in people with Carpal Tunnel Syndrome, run by Pressure Profile Systems, Inc. at 3 sites in United States.
Trial 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). 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?
- Study Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Oct 2018to 21 Apr 2020
- 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
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cleveland Clinic (Lerner Research Institute)
Cleveland, Ohio, 44195
Mission Pain & Spine
Mission Viejo, California, 92691
South Bay Medical Center
Torrance, California, 90710
About this study
Official title: Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Study Device, Sham Device
- Keywords
- carpal tunnel syndrome, carpal tunnel, CTS, musculoskeletal disorder, peripheral neuropathy, repetitive stress injury, non-invasive device, non-significant risk, medical device, wrist pain
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy, Musculoskeletal Diseases, Peripheral Nervous System Diseases, Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study DeviceDevice
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 DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Device | Experimental | Small, non-invasive, stiff patch for the wrist Receives: Device: Study Device |
| Sham Device | Sham comparator | Device that looks like the Study Device but modified to prevent or remove the main mechanism of action. Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCTQ SSS at 8 Weeks vs 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).
Measured: baseline and 8 weeks post-Baseline
Secondary outcomes (1)
BCTQ SSS
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).
Measured: 8-weeks post-Baseline and 12 weeks post-Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start10 Oct 2018
- Primary completion28 Feb 2020
- Study completion21 Apr 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pressure Profile Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic, Mission Pain and Spine, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Jae Son, PhD, Study director, Pressure Profile Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498287
- Sponsor's protocol ID
- PPS-CTS-SBIR2
- Status last verified
- Jun 2020
- First submitted
- 8 Apr 2018
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 17054773
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of Non-invasive Device to Alleviate Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03498287
- Acronym / sponsor ID
- PPS-CTS-SBIR2
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, carpal tunnel, CTS, musculoskeletal disorder, peripheral neuropathy, repetitive stress injury, non-invasive device, non-significant risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Pressure Profile Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic, Mission Pain and Spine, Kaiser Permanente
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Posted 14 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Device | Experimental | Device: Study DeviceSmall, non-invasive, stiff patch for the wrist |
| Sham Device | Sham comparator | Device: Sham DeviceDevice that looks like the Study Device but modified to prevent or remove the main mechanism of action. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (17 listed)
- Other upper extremity neuropathies (e.g., epicondylitis, radial nerve neuropathies, ulnar nerve neuropathies)
- Double crush syndrome
- Cervical stenosis
- Brachial plexopathy
- Wrist fractures or cysts
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 |
|---|---|---|
| Study DeviceReal 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). | Device | Study Device |
| Sham DeviceSham 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. | Device | Sham Device |
Primary outcome
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).
1 secondary outcome
BCTQ SSS
Time frame: 8-weeks post-Baseline and 12 weeks post-Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17054773Leite 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.
- Practice Parameter for Electrodiagnostic Studies in Carpal Tunnel Syndrome: Summary Statement.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jae Son, PhD study director
Pressure Profile Systems
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Device in people with Carpal Tunnel Syndrome, run by Pressure Profile Systems, Inc. at 3 sites 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 8 inclusion and 17 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 14 Jul 2020). 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?
BCTQ SSS at 8 Weeks vs Baseline (time frame: baseline and 8 weeks post-Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03498287, which also lists 1 linked publication.
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 14 Jul 2020.