Phase 2
N=10
Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves
Unilateral Carpal Tunnel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00665132 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Implant Success — 10 participants with successful implant
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- StimRouter System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bioness Inc
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Success |
10 | — |
| SECONDARY Patent Satisfaction |
9.6 | — |
| SECONDARY Percent of Participants Reporting Pain Change From Baseline to Day 5 |
90 | — |
| SECONDARY Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5 |
2.9 | — |
Summary
This study is being done to see how well a new investigational medical device, the StimRouter (STR) System, will work to treat the chronic pain in people who have failed previous treatments for Carpal Tunnel Syndrome (CTS) pain, including surgery. These people have been treated for CTS pain before including surgical carpal tunnel release, but without good results, and they are still having pain. The study will look at both the good and bad effects of the StimRouter System for treating this kind of pain and as a general peripheral nerve stimulation device for treating chronic pain. The study will also help to understand other possible uses for the StimRouter System.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Chronic peripheral pain persisting for greater than or equal to 3 months diagnosed previously as a mononeuropathy of the median nerve at the level of the carpal tunnel (i.e., diagnosed CTS)
- Average chronic pain level greater than or equal to 5/10 [on 0-10 numeric rating scale (NRS) (BPI#14)], where such pain is attributed to injury, irritation, or entrapment of the median nerve at the level of the carpal tunnel (i.e., diagnosed CTS)
- Failure of a single prior carpal tunnel release surgery to provide relief, where such failed surgery was performed greater than or equal to study entry
- Able to tolerate stimulation (TENS)
- Temporary pain relief is achieved by local anesthetic block of the target median nerve suspected to be the source of chronic pain symptoms
- Ability to give informed consent and understand study requirements
- Ability to quantify pain using a 0-10 numeric rating scale [A screening tool will be used to ensure that subjects can rate 3 common pain scenarios (mosquito bite, stubbed toe and broken bone) on a 0-10 NRS relative to each other, with mosquito bite 2 seizures per month)
- Pregnant or plan on becoming pregnant or breastfeeding during the study period
- Currently require, or likely to require, diathermy and/or MRI during the study duration
- History of adverse reactions to local anesthetic (e.g., lidocaine)
Data sourced from ClinicalTrials.gov (NCT00665132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.