NCT03740750

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

November 8, 2018

Last Update Submit

November 13, 2018

Conditions

Pain

Keywords

heathot temperaturecutaneous electrostimulation

Outcome Measures

Primary Outcomes (9)

  • 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)

Study Arms (6)

control

PLACEBO COMPARATOR

sham heat and sham TENS

Device: sham heatDevice: sham Tens

heat only

EXPERIMENTAL

heat applied to the back for 4 hours with sham TENS

Device: Thermacare heat wrapsDevice: sham Tens

Tens only

EXPERIMENTAL

Tens applied for 4 hours with sham heat

Device: TENSDevice: sham heat

Heat and Tens continuous

EXPERIMENTAL

Heat and Tens applied together for 4 hours

Device: Thermacare heat wrapsDevice: TENS

Tens 15

EXPERIMENTAL

Tens applied only 15 minutes each hour for 4 hours, sham heat

Device: TENSDevice: sham heat

Heat and Tens 15

EXPERIMENTAL

Heat applied for 4 hours with tens only applied the last 15 minutes of each hour

Device: Thermacare heat wrapsDevice: TENS

Interventions

Thermacare heat wrapsDEVICE

low level continuous heat wrap

Heat and Tens 15Heat and Tens continuousheat only
TENSDEVICE

electrical stimulation

Heat and Tens 15Heat and Tens continuousTens 15Tens only
sham heatDEVICE

expended heat wrap

Tens 15Tens onlycontrol
sham TensDEVICE

tens applied but unit not turned on

controlheat only

Eligibility Criteria

Age24 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pain for at least 3 months in the lower back
  • age range 24-60

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Future Sciecne Technology

Henderson, Nevada, 89113, United States

RECRUITING

Related 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.

    PMID: 29381114RESULT

  • 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.

    PMID: 28282796RESULT

  • 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.

    PMID: 25419887RESULT

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Mike Laymon, PT, DSC

    Future Science Technology

    STUDY DIRECTOR

Central Study Contacts

jerrold S petrofsky, Ph D

CONTACT

7143215424jpetrofsky@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 6 different interventions will be tested in parallel on 6 equivalent groups of subjects
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 14, 2018

Study Start

October 15, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

US(1)