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This is a prospective, sham-controlled, randomized, single-blinded, multi-center study comparing two different modes of the NexWave device, transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC), with an identical non-functioning NexWave sham device or self-defined standard of care for improvement of pain intensity of non-specific CLBP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device TENS | Experimental |
| |
| Device IFC | Experimental |
| |
| Sham TENS | Sham Comparator |
| |
| Sham IFC | Sham Comparator |
| |
| Control | No Intervention | Subjects continue with current standard of care only for 4 weeks with the option to crossover to the NexWave Device group for an additional 4 weeks (up to 8 total weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NexWave | Device | Device subjects receive designated treatment mode twice daily for up to 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale Pain Rating - NexWave vs. Sham | VAS pain rating between baseline and four weeks for NexWave subjects as compared to sham device subjects. | Four weeks |
| Visual Analogue Scale Pain Rating - NexWave vs. Control | VAS pain rating between baseline and four weeks for NexWave subjects as compared to control or sham device subjects. | Four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) - NexWave vs. Sham | ODI scores between baseline and four weeks for NexWave subjects as compared to sham device subjects. | Four weeks |
| Oswestry Disability Index (OD) - NexWave vs. Control |
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Inclusion Criteria:
Ages 18-70, or older if specified by law
Non-specific chronic lower back pain defined as:
Subjects who are willing and capable of providing informed consent
Subjects who are willing and capable of participating in all testing and questionnaire requirements associated with the clinical study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Gilmore, MD | The Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DBPS Research | Greenwood Village | Colorado | 80111 | United States | ||
| McGreevy NeuroHealth |
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| Sham | Device | Sham subjects provided with Sham Device and treatment instructions identical to that of NexWave Device Arm for their designated Sham Arm. Sham subjects participate for 4 weeks with the option to crossover to the NexWave Device Arm for an additional 4 weeks (up to 8 weeks total). |
|
ODI scores between baseline and four weeks for NexWave subjects as compared to control or sham device subjects.
| Four weeks |
| Saint Augustine |
| Florida |
| 32095 |
| United States |
| Peachtree Orthopedics | Atlanta | Georgia | 30327 | United States |
| Horizon Clinical Research | Jasper | Georgia | 30143 | United States |
| Applied Pain Institute, LLC | Bloomington | Illinois | 61701 | United States |
| One Oak Medical | Congers | New York | 10920 | United States |
| The Center for Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Summit Brain, Spine and Orthopedics | Lehi | Utah | 84043 | United States |