TENS and Heat for Reducing Back Pain in Humans

Not Applicable

• Conditions: Pain

• Registration Number: NCT03740750
• Lead Sponsor: Future Sciene Technology

Brief 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.

Study Timeline

• Study Start: 2018-10-15
• Status Verified: 2018-11
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. pain for at least 3 months in the lower back
2. age range 24-60

Exclusion Criteria

1. Those with back pain caused by fractures or spinal damage
2. those who had undergone low back surgery within the last year
3. those with diagnosed diabetes
4. no use of opiod pain meds for at least 10 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pressure on back that causes pain	10 hours after study start( 6 hours after the modality ends)	pressure applied to lower back until pain is felt to assess inflammation
range of motion of the hip for flexion, extension,left and right rotation,left and right bending	10 hours after study start( 6 hours after the modality ends)	range of motion in 6 degrees of freedom in the lower back
subjective pain by marking on scale	10 hours after study start( 6 hours after the modality ends)	analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst

Trial Locations

Locations (1)

Future Sciecne Technology; 🇺🇸 Henderson, Nevada, United States