Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02135094 · ClinicalTrials.gov registry record · NA
Low Intensity Ultrasound Therapy for Upper Back Pain Relief
A NA study, sponsored by ZetrOZ.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT02135094: Completed NA study, sponsored by ZetrOZ.
NCT02135094 is a NA study that has completed, run by ZetrOZ. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02135094, a NA study, has completed, sponsored by ZetrOZ.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device for relief of pain associated with the trapezius muscle of the upper back over a 4-week period. The trapezius muscle is a wide, flat, superficial muscle that covers most of the upper back and the posterior of the neck.The hypothesis is that the ultrasound device will lower the reported daily pain level of subjects suffering from trapezius muscle pain in their upper back. Subjects who participate in the study will self-administer the ultrasound device daily if pain is rated 3.0 or higher on the numeric rating scale (0-10). Subjects will be required to visit the clinical site at enrollment and weeks 2 and 4 for a total of 3 visits. Subjects will report their daily pain levels in a diary. Subject will also report pain levels at 30 min, 2 hours, and 4 hours (treatment completion) after start of each treatment. The wearable ultrasound device, Sam®, has been cleared by the FDA for pain relief, relief of joint contracture, relief of muscle spasm, and increased circulation.
Primary Outcome
Patients applied the ultrasound device when trapezius muscle pain exceeds a score of 3 or higher by numeric rating scale (NRS). NRS range was 0-10 with 0 being no pain and 10 the worst pain possible. Device maybe be worn safely for 4 h per day for 7 days a week. Participants recorded NRS score daily (pre-treatment) and on days when the device was applied participants recorded pain 30 minutes into treatment, 2 hours into treatment and post-treatment (after 4 hours). The post-treatment score is us
Interventions
- DEVICE Active ultrasound therapy device
- DEVICE Placebo ultrasound therapy device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT02135094 record still lists
NCT02135094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Active ultrasound therapy device is the first listed.
NCT02135094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02135094 about?
NCT02135094 is a clinical study titled "Low Intensity Ultrasound Therapy for Upper Back Pain Relief". The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device for relief of pain associated with the trapezius muscle of the upper back over a 4-week period. The trapezius muscle is a wide, flat, superficial muscle that covers most of the upper back and the po...
What is the current status of trial NCT02135094?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2014-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02135094?
The interventions under investigation include: Active ultrasound therapy device (DEVICE), Placebo ultrasound therapy device (DEVICE).
Who is sponsoring clinical trial NCT02135094?
This trial is sponsored by ZetrOZ, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02135094's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02861898 · 33 participants · Phase 1
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
- NCT04871607 · 33 participants · Phase 2
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma
- NCT05071937 · 33 participants · Phase 2
ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
- NCT05168618 · 33 participants · Phase 2
Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer, The AtezoCab Trial
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia