NCT03740750

TENS and Heat for Reducing Back Pain in Humans

The Effect of 4 Hours of Tens and Heat on Pain and Range of Motion in the Lower Back and the Duration of Pain Relief After Tens and Heat Are Removed

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Future Sciene Technology · Industry
• Sex: All
• Age: 24 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

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; 1. Control 2. heat only 3. Tens only 4. Tens and heat 5. Tens for the last 15 minutes each hour plus heat 6. Tens for the last 15 minutes each hour Tens is at threshold intensity (12 ma) at a frequency of 20 Hz either ramped continuously or for the last 15 minutes of each hour. The stimulation is 3 seconds increase to threshold, 3 seconds hold and 3 seconds ramped down followed by a 9 second rest period. Pain is assessed by an analog visual pain scale and an algometer placing pressure on the back to assess the pressure that causes pain, a measure of inflammation. In addition, the Oswestry lower back pain index and Roland Morris questionnaire are used. Range of motion in the trunk where first pain is felt is also measured.

Conditions

• Pain

Interventions

Type	Name	Description
DEVICE	Thermacare heat wraps	low level continuous heat wrap
DEVICE	TENS	electrical stimulation
DEVICE	sham heat	expended heat wrap
DEVICE	sham Tens	tens applied but unit not turned on

Timeline

• Start date: 2018-10-15
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-11-14
• Last updated: 2018-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study