An interventional study of Study Device and Sham Device in Carpal Tunnel Syndrome, sponsored by Pressure Profile Systems, Inc.. Completed at 3 sites in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by Pressure Profile Systems, Inc. · Not applicable, Interventional, and Treatment
Among 97 studies in Carpal Tunnel Syndrome with a site in United States — 11 open to participants now, 13 under way, none of them phase 3. Carpal Tunnel Syndrome · United States.
Among the 97 studies in Carpal Tunnel Syndrome with a site in United States, this one is the 27th largest by enrollment of the 72 interventional ones that give a count, is one of 9 that started in 2018, is one of 47 with no phase, and was the 53rd registered.
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
Browse Carpal Tunnel Syndrome studies →11 of the 97 studies in Carpal Tunnel Syndrome with a site in United States are open now. Recruiting first, the newest first:
New York Institute of Technology · Sites in United States
University of Nevada, Las Vegas · Sites in United States
Brooke Army Medical Center · Sites in United States
University of Arizona · Sites in United States
University of Chicago · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 74 Carpal Tunnel Syndrome studies recruiting now, 27 (36%) set no upper age limit and 38 (51%) stop at 75 or younger; 1 take children under 18; 10 take healthy volunteers.
This study: 21 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
97 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 11 · Phase 3 2 · Phase 4 10
First in 1997; this study’s year is marked. 9 started in 2018.
This study's enrollment of 88 is above the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.
Median enrollment 50 across the 72 interventional studies, 107 across the 24 observational. Of the 67 that completed or were terminated, 16 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
15 of 97 have an industry lead sponsor. The 10 most frequent:
Pressure Profile Systems, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Pressure Profile Systems, Inc. has 2 studies filed under Carpal Tunnel Syndrome — fewer than ten, so there is no comparison to draw.
4 of the studies in Carpal Tunnel Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04804293Mayo ClinicAssessment of Carpal Tunnel Syndrome by Shearwave Elastography | 2026-12-20 |
| NCT07158892University of Texas at AustinUnderstanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test | 2027-01-20 |
| NCT06907849University of Tennessee Graduate School of Medicine124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome | 2027-03 |
| NCT04206215Spaulding Rehabilitation HospitalNoninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome | 2027-07-02 |
Among the 97 studies in Carpal Tunnel Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
CTS diagnosis confirmed by a nerve conduction study (NCS) performed within the past 24 months OR at enrollment/baseline visit
Exclusion Criteria:
To assess eligibility, visit: carpaltunneltrial.com
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Small, non-invasive, stiff patch for the wrist
Device: Study Device
Device that looks like the Study Device but modified to prevent or remove the main mechanism of action.
Device: Sham 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 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.
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).
Time frame: baseline and 8 weeks post-Baseline
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).
Time frame: 8-weeks post-Baseline and 12 weeks post-Baseline
| Milestone | Study Device | Sham Device |
|---|---|---|
| Started | 45 | 43 |
| Completed | 42 | 38 |
| Not completed | 3 | 5 |
| Withdrew: Withdrawal by subject | 3 | 0 |
| Withdrew: Protocol violation | 0 | 4 |
| Withdrew: Adverse event | 0 | 1 |
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).
| score on a scale | Study Device | Sham Device |
|---|---|---|
| Average SSS | 2.16 ± .65 | 2.32 ± .70 |
| Average Change in SSS | -0.62 ± 0.69 | -0.64 ± 0.62 |
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).
| score on a scale | Study Device | Sham Device |
|---|---|---|
| Average SSS @12 weeks | 2.24 ± .70 | 2.44 ± .68 |
| Average Change in SSS between 12 and 8 weeks | 0.08 ± 0.48 | 0.12 ± 0.40 |
Collected over Patient participation duration: 5-6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Device | 0/42 (0%) | 0/42 (0%) | 2/42 (4.8%) |
| Sham Device | 0/38 (0%) | 0/38 (0%) | 2/38 (5.3%) |
| Event | Study Device | Sham Device |
|---|---|---|
| Rash, redness, or sore under study deviceInjury, poisoning and procedural complications | 2/42 | 2/38 |
| Age, Categorical(Participants) | Study Device | Sham Device | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 42 | 37 | 79 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Study Device | Sham Device | Total |
|---|---|---|---|
| Mean | 48.6 ± 11.7 | 48.6 ± 9.9 | 48.6 ± 10.8 |
| Sex/Gender, Customized(Participants) | Study Device | Sham Device | Total |
|---|---|---|---|
| Female | 34 | 27 | 61 |
| Male | 8 | 10 | 18 |
| Decline to Answer | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Study Device | Sham Device | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 3 | 10 |
| Not Hispanic or Latino | 25 | 22 | 47 |
| Unknown or Not Reported | 10 | 13 | 23 |
| Race (NIH/OMB)(Participants) | Study Device | Sham Device | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 32 | 30 | 62 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Score (SSS)(units on a 1-5 Likert scale) | Study Device | Sham Device | Total |
|---|---|---|---|
| Mean | 2.78 ± .58 | 2.96 ± .42 | 2.87 ± .52 |
| BCTQ Functional Severity Score (FSS)(units on a 1-5 Likert scale) | Study Device | Sham Device | Total |
|---|---|---|---|
| Mean | 2.21 ± .72 | 2.39 ± .70 | 2.30 ± .71 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2018 to primary completion in Feb 2020, 16 months.
Results were first posted in Jul 2020, 4 months after primary completion.
Of 261 interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's 16 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Pressure Profile Systems, Inc.