N/A
N=113
Comparison of Electrotherapies for Chronic Low Back Pain
Non-specific Chronic Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01658735 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Change From Baseline in Oswestry Disability Index at 1 Week — -2.507; -4.725; -4.752 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- H-Wave (Device); Transcutaneous Electrical Nerve Stimulation (TENS) (Device); Sham (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Oswestry Disability Index at 1 Week |
-2.507; -4.725; -4.752 | — |
| PRIMARY Change From Baseline in Oswestry Disability Index at 4 Weeks |
-5.002; -5.135; -4.581 | — |
| PRIMARY Change From Baseline in Oswestry Disability Index at 8 Weeks |
-5.299; -5.135; -4.679 | — |
| PRIMARY Change From Baseline in Oswestry Disability Index at 12 Weeks |
-5.388; -6.907; -5.612 | — |
| SECONDARY Change From Baseline in VAS Pain Score at 1 Week |
-1.458; -1.929; -2.042 | — |
| SECONDARY Change From Baseline in VAS Pain Score at 4 Weeks |
-2.017; -1.691; -1.843 | — |
| SECONDARY Change From Baseline in VAS Pain Score at 8 Weeks |
-2.510; -2.147; -2.467 | — |
| SECONDARY Change From Baseline in VAS Pain Score at 12 Weeks |
-2.624; -1.922; -2.467 | — |
Summary
The intent of this project is to execute a high-quality double-blinded randomized controlled clinical trial that compares the H-Wave® device with a commonly used TENS device with a sub-therapeutic electrocurrent device. This study will provide a definable level of evidence for treatment efficacy, and provide a basis for evidence-based recommendation for or against utilization for these two modalities. The results for H-Wave® device, if positive, could significantly impact morbidity by providing a non-invasive, non-pharmacologic treatment for symptomatic relief, and reduce overall disability and health care costs associated with chronic low back pain.
Eligibility Criteria
Inclusion Criteria
- Chronic Low Back Pain of at least 3 months duration
- ages 18-65
- Current VAS Pain Rating of 5 on 10 point scale
- No pain below the knee
- 75% of pain located in low back or buttock pain rather than lower extremity pain
- Proficient in English
- Able to complete and tolerate treatment for the study period.
Exclusion Criteria
- Prior home use of H-Wave Device or TENS.
- Prior history of spinal fusion or failed spinal surgery syndrome.
- Laminectomy, laminotomy or discectomy within 12 months of enrollment.
- Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency, neuroablation within 6 months of enrollment.
- Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, or other implanted electronic devices.
- Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia, uncontrolled depression or anxiety disorder).
- Patients currently or who become pregnant will be excluded.
Data sourced from ClinicalTrials.gov (NCT01658735). 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.