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heat only for Pain

N/A
Waitlist Available
Research Sponsored by Future Sciene Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 hours after study start( 6 hours after the modality ends)

Summary

Lower back pain is one of the most common and most expensive impairments costing time and expense in the work force today. With the effects on cognitive skills and addictive side effects of opioids and other prescription pain killers, there has been increasing interest in alternative medical treatments to relieve pain. Two of these that are commonly used are heat and transcutaneous electrical nerve stimulation (TENS). In the present investigation, there are two objectives 1) to determine if Tens needs to be continuous or can be intermittent and still achieve pain relief and 2) To see how long pain relief lasts after 4 hours of application of tens, heat or both. There will be seventy-five subjects with chronic back pain divided into 6 groups randomly; 15 subjects per group. The intervention will be either TENS alone, Heat alone or Tens plus heat or a control group.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 hours after study start( 6 hours after the modality ends)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 hours after study start( 6 hours after the modality ends) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
pressure on back that causes pain
range of motion of the hip for flexion, extension,left and right rotation,left and right bending
subjective pain by marking on scale

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: heat onlyExperimental Treatment2 Interventions
heat applied to the back for 4 hours with sham TENS
Group II: Tens onlyExperimental Treatment2 Interventions
Tens applied for 4 hours with sham heat
Group III: Tens 15Experimental Treatment2 Interventions
Tens applied only 15 minutes each hour for 4 hours, sham heat
Group IV: Heat and Tens continuousExperimental Treatment2 Interventions
Heat and Tens applied together for 4 hours
Group V: Heat and Tens 15Experimental Treatment2 Interventions
Heat applied for 4 hours with tens only applied the last 15 minutes of each hour
Group VI: controlPlacebo Group2 Interventions
sham heat and sham TENS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TENS
2011
Completed Phase 2
~2040

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Who is running the clinical trial?

Future Sciene TechnologyLead Sponsor
1 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Pain
90 Patients Enrolled for Pain
Mike Laymon, PT, DSCStudy DirectorFuture Science Technology
~13 spots leftby Nov 2025