An interventional study of Thermacare heat wraps and TENS in Pain, sponsored by Future Sciene Technology. Status unknown at 1 site in United States. Open to participants aged 24 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Future Sciene Technology · Not applicable, Interventional, and Treatment
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.
There will be seventy-five subjects with chronic back pain divided into 6 groups randomly; 15 subjects per group. They are between the ages of 24 and 60 years old. They will not be taking pain medications for at least 48 hours prior to the study. The groups were as follows;
Future Sciene Technology is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
sham heat and sham TENS
Device: sham heat · Device: sham Tens
heat applied to the back for 4 hours with sham TENS
Device: Thermacare heat wraps · Device: sham Tens
Tens applied for 4 hours with sham heat
Device: TENS · Device: sham heat
Heat and Tens applied together for 4 hours
Device: Thermacare heat wraps · Device: TENS
Tens applied only 15 minutes each hour for 4 hours, sham heat
Device: TENS · Device: sham heat
Heat applied for 4 hours with tens only applied the last 15 minutes of each hour
Device: Thermacare heat wraps · Device: TENS
low level continuous heat wrap
electrical stimulation
expended heat wrap
tens applied but unit not turned on
range of motion of the hip for flexion, extension,left and right rotation,left and right bending
range of motion in 6 degrees of freedom in the lower back
Time frame: Baseline (beginning of study before intervention)
subjective pain by marking on scale
analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst
Time frame: Baseline (beginning of study before intervention)
pressure on back that causes pain
pressure applied to lower back until pain is felt to assess inflammation
Time frame: Baseline (beginning of study before intervention)
range of motion of the hip for flexion, extension,left and right rotation,left and right bending
range of motion in 6 degrees of freedom in the lower back
Time frame: 4 hours after study start- at end of intervention
subjective pain by marking on scale
analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst
Time frame: 4 hours after study start- at end of intervention
pressure on back that causes pain
pressure applied to lower back until pain is felt to assess inflammation
Time frame: 4 hours after study start- at end of intervention
range of motion of the hip for flexion, extension,left and right rotation,left and right bending
range of motion in 6 degrees of freedom in the lower back
Time frame: 10 hours after study start( 6 hours after the modality ends)
subjective pain by marking on scale
analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst
Time frame: 10 hours after study start( 6 hours after the modality ends)
pressure on back that causes pain
pressure applied to lower back until pain is felt to assess inflammation
Time frame: 10 hours after study start( 6 hours after the modality ends)
Plan to share: Undecided
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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