TENS and Heat for Reducing Back Pain in Humans

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03740750
• Other study ID #: jand m18
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2018
• Source: Future Sciene Technology
• Contact: jerrold S petrofsky, Ph D
• Phone: 7143215424
• Email: jpetrofsky[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Thermacare heat wraps
low level continuous heat wrap
• TENS
electrical stimulation
• sham heat
expended heat wrap
• sham Tens
tens applied but unit not turned on

Locations

Country	Name	City	State
United States	Future Sciecne Technology	Henderson	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Future Sciene Technology

Country where clinical trial is conducted

United States, 

References & Publications (3)

Petrofsky J, Laymon M, Khowailed I, Lee H. Synergistic Effects of Continuous Low Level Heat Wraps and Vitamins in Improving Balance and Gait in Adults. Int J Vitam Nutr Res. 2016 Jun;86(3-4):152-160. doi: 10.1024/0300-9831/a000428. Epub 2018 Jan 30. — View Citation

Petrofsky JS, Laymon M, Alshammari F, Khowailed IA, Lee H. Use of low level of continuous heat and Ibuprofen as an adjunct to physical therapy improves pain relief, range of motion and the compliance for home exercise in patients with nonspecific neck pai — View Citation

Stark J, Petrofsky J, Berk L, Bains G, Chen S, Doyle G. Continuous low-level heatwrap therapy relieves low back pain and reduces muscle stiffness. Phys Sportsmed. 2014 Nov;42(4):39-48. doi: 10.3810/psm.2014.11.2090. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline (beginning of study before intervention)
Primary	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	Baseline (beginning of study before intervention)
Primary	pressure on back that causes pain	pressure applied to lower back until pain is felt to assess inflammation	Baseline (beginning of study before intervention)
Primary	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	4 hours after study start- at end of intervention
Primary	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	4 hours after study start- at end of intervention
Primary	pressure on back that causes pain	pressure applied to lower back until pain is felt to assess inflammation	4 hours after study start- at end of intervention
Primary	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	10 hours after study start( 6 hours after the modality ends)
Primary	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	10 hours after study start( 6 hours after the modality ends)
Primary	pressure on back that causes pain	pressure applied to lower back until pain is felt to assess inflammation	10 hours after study start( 6 hours after the modality ends)