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

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Device: sham heat; Device: sham Tens; Device: Thermacare heat wraps; Device: TENS

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Henderson, Nevada, United States, 89113
      • Recruiting
      • Future Sciecne Technology
      • Contact: jerrold petrofsky, ph d

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; sham heat and sham TENS	Device: sham heat; expended heat wrap; Device: sham Tens; tens applied but unit not turned on
Experimental: heat only; heat applied to the back for 4 hours with sham TENS	Device: sham Tens; tens applied but unit not turned on; Device: Thermacare heat wraps; low level continuous heat wrap
Experimental: Tens only; Tens applied for 4 hours with sham heat	Device: sham heat; expended heat wrap; Device: TENS; electrical stimulation
Experimental: Heat and Tens continuous; Heat and Tens applied together for 4 hours	Device: Thermacare heat wraps; low level continuous heat wrap; Device: TENS; electrical stimulation
Experimental: Tens 15; Tens applied only 15 minutes each hour for 4 hours, sham heat	Device: sham heat; expended heat wrap; Device: TENS; electrical stimulation
Experimental: Heat and Tens 15; Heat applied for 4 hours with tens only applied the last 15 minutes of each hour	Device: Thermacare heat wraps; low level continuous heat wrap; Device: TENS; electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
pressure on back that causes pain	pressure applied to lower back until pain is felt to assess inflammation	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	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	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	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	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	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	10 hours after study start( 6 hours after the modality ends)

Collaborators and Investigators

• Sponsor: Future Sciene Technology
• Investigators: Study Director: Mike Laymon, PT, DSC, Future Science Technology

Publications and helpful links

General Publications

• 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.
• 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 pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2017;30(4):889-896. doi: 10.3233/BMR-160577.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: heat; hot temperature; cutaneous electrostimulation
• Other Study ID Numbers: jand m18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No