Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Acute Low-back Pain; Chronic Low-back Pain; Pain, Intractable

• Registration Number: NCT04494698
• Lead Sponsor: MMJ Labs LLC

Brief Summary

Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control

Detailed Description

160 patients with moderate to severe acute or exacerbations of chronic low back pain presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate; or an 8 channel prescription TENS unit. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Study Start: 2022-06-23
• Primary Completion: 2024-07-09
• Study Completion: 2025-06-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

• Pacemaker
• Radicular pain likely reflecting a surgical or mechanical problem
• BMI greater than 50 (device won't fit, initially thought to be BMI 30 but up to 50 included)
• 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 or Active Control TENS Device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in current pain intensity from initial to final	Daily for 30 days, then weekly and monthly until 3 months (acute) or 6 months (chronic)	Self-rated current pain on Numeric Rating Scale with 0 no pain and 10 maximum pain
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference	Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)	Response formats for all scales are a 5-point ordinal rating scale of "Not at all," "A little bit," "Somewhat," "Quite a bit," and "Very much," where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest) normed on a T-Score where 50 is the average in the United States, 40.7 is "no disability", 55 is mild, 57.7 is moderate, and 65.7 is severe

Secondary Outcome Measures

Name	Time	Method
Resolution of disability using PROMIS Pain Interference	Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)	Achievement of average pain interference of a T-Score of 50 at last recorded PROMIS Pain Interference
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (8a) measures in those with intractable pain as defined and compared with surgical multifidus intervention studies	Initial through 6 month measurements (or 13 week if chronic enrolled as acute)	Comparison between the experimental and active control interventions crosswalked with the Oswestry Disability outcomes in multifudus electrical stimulation studies.

Trial Locations

Locations (2)

Sport and Spine Rehab Clinics; 🇺🇸 Landover, Maryland, United States

Sport and Spine Rehab Clinic; 🇺🇸 Fairfax, Virginia, United States