Low Back Pain, Low Back Pain, Recurrent, Low Back Sprain
Conditions
Keywords
Medical Device, Buzzy, Vibration, thermomechanical
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.
Interventions
Low back plate belt with mechanicothermal and pressure intervention options.
Sponsors
National Institute on Drug Abuse (NIDA)
Sport and Spine Rehab Clinical Research Foundation
MMJ Labs LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Consecutive low back pain patients were offered to try a new device and give feedback on a prototype. Once the feedback was obtained, the changes were incorporated into a production-ready model and re-evaluated.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DuoTherm VibraCool Back Device Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | DuoTherm VibraCool Back Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 41.9 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Change in Pain: Visual Analog Scale (VAS)
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.
Time frame: Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DuoTherm VibraCool Back Device | Change in Pain: Visual Analog Scale (VAS) | 2.1 units on a scale (centimeters) | Standard Deviation 1.4 |
Primary
Participants' Choice in Thermal Options
One of four options: hot, cold, none, both
Time frame: 30 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DuoTherm VibraCool Back Device | Participants' Choice in Thermal Options | Both | 0 Participants |
| DuoTherm VibraCool Back Device | Participants' Choice in Thermal Options | Hot | 9 Participants |
| DuoTherm VibraCool Back Device | Participants' Choice in Thermal Options | Cold | 11 Participants |
| DuoTherm VibraCool Back Device | Participants' Choice in Thermal Options | None | 0 Participants |
Primary
Would You Recommend
Binary approval or disapproval of device
Time frame: After 30 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DuoTherm VibraCool Back Device | Would You Recommend | Approve | 20 Participants |
| DuoTherm VibraCool Back Device | Would You Recommend | Disapprove | 0 Participants |
Secondary
Subjective Pain Relief
7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DuoTherm VibraCool Back Device | Subjective Pain Relief | 5.3 score on a scale | Standard Deviation 0.98 |