Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain

Not Applicable

Completed

Brief 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.

Detailed Description: To facilitate data collection of a short-term intervention, the investigators chose to enroll patients from a mixed physical therapy/chiropractic practice with demographic and economic diversity in the metro Washington area. The neuromodulatory device will have patient controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute thermal capacity. A convenience sample of 10 patients at the clinic was invited to give feedback on the prototype device after informed consent. Changes suggested were incorporated and after informed consent a second group of ten gave will give feedback with the production-ready device.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Change in Pain: Visual Analog Scale (VAS)	Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation	Difference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant.
Participants' Choice in Thermal Options	30 minutes	One of four options: hot, cold, none, both
Would You Recommend	After 30 minutes	Binary approval or disapproval of device

Secondary Outcome Measures

Name	Time	Method
Subjective Pain Relief	30 minutes	7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study

Locations (1): Sport and Spine Rehab Clinic
🇺🇸
Rockville, Maryland, United States
Sport and Spine Rehab Clinic
🇺🇸Rockville, Maryland, United States