Clinical trial NCT03740750: TENS and Heat for Reducing Back Pain in Humans
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: heat
hot temperature
cutaneous electrostimulation
Lead sponsor: Future Sciene Technology
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 90
Sex: ALL
Minimum age (years): 24
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 6 different interventions will be tested in parallel on 6 equivalent groups of subjects
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: range of motion of the hip for flexion, extension,left and right rotation,left and right bending
timeFrame: Baseline (beginning of study before intervention)
measure: subjective pain by marking on scale
timeFrame: Baseline (beginning of study before intervention)
measure: pressure on back that causes pain
timeFrame: Baseline (beginning of study before intervention)
measure: range of motion of the hip for flexion, extension,left and right rotation,left and right bending
timeFrame: 4 hours after study start- at end of intervention
measure: subjective pain by marking on scale
timeFrame: 4 hours after study start- at end of intervention
measure: pressure on back that causes pain
timeFrame: 4 hours after study start- at end of intervention
measure: range of motion of the hip for flexion, extension,left and right rotation,left and right bending
timeFrame: 10 hours after study start( 6 hours after the modality ends)
measure: subjective pain by marking on scale
timeFrame: 10 hours after study start( 6 hours after the modality ends)
measure: pressure on back that causes pain
timeFrame: 10 hours after study start( 6 hours after the modality ends)
Secondary outcomes:
Other outcomes:
Locations:
city: Henderson
country: United States
facility: Future Sciecne Technology
state: Nevada
Study officials:
affiliation: Future Science Technology
name: Mike Laymon, PT, DSC
role: STUDY_DIRECTOR
References:
citation: 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.
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 pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2017;30(4):889-896. doi: 10.3233/BMR-160577.
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.