N/A
Completed N=20
Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain
Low Back Pain · Low Back Sprain · Low Back Pain, Recurrent
Source: ClinicalTrials.gov NCT04494841 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Change in Pain: Visual Analog Scale (VAS) — 2.1 units on a scale (centimeters)
Summary
Ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will be elicited.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain: Visual Analog Scale (VAS) |
2.1 | — |
| PRIMARY Participants' Choice in Thermal Options |
9; 11; 0; 0 | — |
| PRIMARY Would You Recommend |
20; 0 | — |
| SECONDARY Subjective Pain Relief |
5.3 | — |
Eligibility Criteria
Inclusion Criteria
- Acute or chronic low back pain as chief complaint
- Capacity to understand all relevant risks and potential benefits of the study (informed consent);
- Willingness to communicate information
Exclusion Criteria
- Radicular pain likely reflecting a surgical or mechanical problem
- BMI greater than 30 (device won't fit)
- Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
- Diabetic neuropathy rendering a patient unable to determine if the device is too hot
- New neurologic deficits
- Skin lesions over the low back area
- Contraindication to any medication for pain management that would impact analgesic use record
- Inability to apply DuoTherm
Data sourced from ClinicalTrials.gov (NCT04494841). 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. Informational only — not medical advice.