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Behavioural Intervention

DuoTherm vs TENS for Lower Back Pain

N/A

Waitlist Available

Research Sponsored by MMJ Labs LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capacity to understand all relevant risks and potential benefits of the study (informed consent)

Self-report NRS measures >4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is evaluating whether the use of opioids combined with the DuoTherm device is more effective at reducing pain compared to the use of opioids with the TENS Therapy Unit.

Who is the study for?

This trial is for adults aged 18-90 with acute low back pain lasting less than 3 months, who haven't been prescribed opioids for this episode. Participants must be able to understand the study and report on their medication use. Those with a BMI over 30, recent opioid prescriptions, pacemakers, certain medical conditions like Raynaud's or diabetic neuropathy, or skin issues in the low back area cannot join.Check my eligibility

What is being tested?

The study compares DuoTherm therapy against TENS (Transcutaneous Electrical Nerve Stimulation) to see which one better reduces opioid use and eases acute lower back pain. Patients will self-report their pain levels and any medications taken during the trial period.See study design

What are the potential side effects?

Potential side effects may include discomfort from device application such as irritation at the site of placement or sensitivity reactions. Since it involves heat and vibration, there might also be risks of burns or aggravation of existing skin conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the risks and benefits of the study.

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I rate my pain or symptom as more than 4 on a scale of 0 to 10.

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My pain has lasted less than 3 months and I haven't taken opioids for it.

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I am 18-90 years old with new low back pain lasting less than 3 months, not treated with opioids, and my pain level is above 4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid initiation

Opioid use in morphine equivalent doses

Secondary outcome measures

Change in 24 hour average pain weekly from initial to resolution

Change in PROMIS Depression measures from initial to completion of study

Change in PROMIS Pain Intensity measure from initial to completion of study

+2 more

Other outcome measures

Duotherm use

Trial Design

2Treatment groups

Active Control

Group I: DuoThermActive Control1 Intervention

A low back pain relief device incorporating 8 harmonic patterns of mechanical stimulation (vibration) capable of neuromodulatory nociceptor block and vasodilation, and optional heat, cold, and pressure delivered through a sculpted metal plate attached with a belt and controlled by buttons on the belt. Patients will be instructed to use the device twice a day for 20 minutes.

Group II: Multimodal TENSActive Control1 Intervention

An 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS twice a day for 20 minutes.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sport and Spine Rehab Clinical Research FoundationOTHER

19 Previous Clinical Trials

812 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,618,573 Total Patients Enrolled

MMJ Labs LLCLead Sponsor

3 Previous Clinical Trials

465 Total Patients Enrolled

Media Library

DuoTherm (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04491175 — N/A

Lower Back Pain Research Study Groups: DuoTherm, Multimodal TENS

Lower Back Pain Clinical Trial 2023: DuoTherm Highlights & Side Effects. Trial Name: NCT04491175 — N/A

DuoTherm (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04491175 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the enrollment of patients progressing for this research?

"Affirmative. With data hosted on clinicaltrials.gov, it can be determined that this medical study is presently enrolling individuals. The trial was originally posted on June 23rd 2022 and the most recent edit happened on October 19th of the same year. Altogether, 60 participants are needed from 3 different sites for the research to be successful."

Answered by AI

Does this medical study cater to elderly individuals?

"This experiment is inviting persons aged 18 and below 90 to participate."

Answered by AI

What positive results are expected from this research?

"This 3-month clinical trial seeks to quantify the efficacy of opioid initiation. Secondary objectives include tracking participants' monthly pain intensity score, depression level, and interference with daily activities caused by their condition."

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Who is eligible for enrollment in this research?

"To be accepted into this medical trial, individuals must report having back pain and have an age of between 18 to 90 years old. Approximately 60 participants are needed for the study."

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Is this clinical investigation still recruiting participants?

"According to clinicaltrials.gov, the recruitment for this trial is still ongoing since it was initially posted on June 23rd 2022 and most recently updated on October 19th 2022."

Answered by AI