Trials / Completed
CompletedNCT05511181
BioWave High-frequency Neurostimulation Versus TENS for the Treatment of Chronic Low Back Pain
High-frequency Sinusoidal Neurostimulation (BioWave) Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Chronic Low Back Pain
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- BioWave Corporation · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This will be a multicenter randomized crossover clinical trial comparing the therapeutic efficacy of BioWave therapy versus TENS for the management of chronic low back pain. This study also aims to evaluate the impact of these therapies on physical activity, patient perception of therapeutic efficacy, and activities of daily living.
Detailed description
This will be a multicenter randomized crossover clinical trial comparing the therapeutic efficacy of BioWave therapy versus TENS for the management of chronic low back pain. This study also aims to evaluate the impact of these therapies on physical activity, patient perception of therapeutic efficacy, and activities of daily living. Patients will start a 30 minute treatment session with either BioWave therapy or TENS device followed by a 30 minute washout and ending with a final 30 minute treatment. Patients will then be instructed to perform two 30 minute treatment sessions daily at home for 2 weeks. Follow-up will be after 2 weeks and the patients will be assessed in clinic for physiologic measures of pain response. A washout period of 2 weeks will follow and the patients will crossover to receive the alternative treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BioWave | The BioWave device is called BioWaveGO. It is a FDA 510(k) cleared high frequency sinusoidal neurostimulator |
| DEVICE | TENS | The TENS device is called Intensity 5000. It is a FDA 510(k) cleared TENS device |
Timeline
- Start date
- 2022-08-15
- Primary completion
- 2023-04-12
- Completion
- 2023-06-30
- First posted
- 2022-08-22
- Last updated
- 2023-07-03
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05511181. Inclusion in this directory is not an endorsement.