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TENS and Heat for Reducing Back Pain in Humans

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ClinicalTrials.gov Identifier: NCT03740750
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Device: Thermacare heat wraps Device: TENS Device: sham heat Device: sham Tens Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 6 different interventions will be tested in parallel on 6 equivalent groups of subjects
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

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: Thermacare heat wraps
low level continuous heat wrap

Device: sham Tens
tens applied but unit not turned on

Experimental: Tens only
Tens applied for 4 hours with sham heat
Device: TENS
electrical stimulation

Device: sham heat
expended heat wrap

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: TENS
electrical stimulation

Device: sham heat
expended heat wrap

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




Primary Outcome Measures :
  1. range of motion of the hip for flexion, extension,left and right rotation,left and right bending [ Time Frame: Baseline (beginning of study before intervention) ]
    range of motion in 6 degrees of freedom in the lower back

  2. subjective pain by marking on scale [ Time Frame: Baseline (beginning of study before intervention) ]
    analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst

  3. pressure on back that causes pain [ Time Frame: Baseline (beginning of study before intervention) ]
    pressure applied to lower back until pain is felt to assess inflammation

  4. range of motion of the hip for flexion, extension,left and right rotation,left and right bending [ Time Frame: 4 hours after study start- at end of intervention ]
    range of motion in 6 degrees of freedom in the lower back

  5. subjective pain by marking on scale [ Time Frame: 4 hours after study start- at end of intervention ]
    analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst

  6. pressure on back that causes pain [ Time Frame: 4 hours after study start- at end of intervention ]
    pressure applied to lower back until pain is felt to assess inflammation

  7. range of motion of the hip for flexion, extension,left and right rotation,left and right bending [ Time Frame: 10 hours after study start( 6 hours after the modality ends) ]
    range of motion in 6 degrees of freedom in the lower back

  8. subjective pain by marking on scale [ Time Frame: 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

  9. pressure on back that causes pain [ Time Frame: 10 hours after study start( 6 hours after the modality ends) ]
    pressure applied to lower back until pain is felt to assess inflammation



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Ages Eligible for Study:   24 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740750


Contacts
Contact: jerrold S petrofsky, Ph D 7143215424 jpetrofsky@outlook.com

Locations
United States, Nevada
Future Sciecne Technology Recruiting
Henderson, Nevada, United States, 89113
Contact: jerrold petrofsky, ph d         
Sponsors and Collaborators
Future Sciene Technology
Investigators
Study Director: Mike Laymon, PT, DSC Future Science Technology

Publications of Results:
Responsible Party: Future Sciene Technology
ClinicalTrials.gov Identifier: NCT03740750     History of Changes
Other Study ID Numbers: jand m18
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Future Sciene Technology:
heat
hot temperature
cutaneous electrostimulation