Recruiting

TENS & Heat

Sponsor:

Future Sciene Technology

Code:

NCT03740750

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 24 - 60

Healthy Volunteers: Accepted

Interventions

Thermacare heat wraps

TENS

sham heat

sham Tens

Study Details

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.

Conditions

Pain

Study ID

NCT03740750

Start date

Oct 15, 2018

Status verified date

Nov, 2018

Completion date

Dec 31, 2018

Anticipated

Primary completion date

Dec 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 24 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: control

sham heat and sham TENS

experimental: heat only

heat applied to the back for 4 hours with sham TENS

experimental: Tens only

Tens applied for 4 hours with sham heat

experimental: Heat and Tens continuous

Heat and Tens applied together for 4 hours

experimental: Tens 15

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

experimental: Heat and Tens 15

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

Interventions

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

Primary outcome measure

  • 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) ]
  • subjective pain by marking on scale [ Time Frame: Baseline (beginning of study before intervention) ]
  • pressure on back that causes pain [ Time Frame: Baseline (beginning of study before intervention) ]
  • 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 ]
  • subjective pain by marking on scale [ Time Frame: 4 hours after study start- at end of intervention ]
  • pressure on back that causes pain [ Time Frame: 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 [ Time Frame: 10 hours after study start( 6 hours after the modality ends) ]
  • subjective pain by marking on scale [ Time Frame: 10 hours after study start( 6 hours after the modality ends) ]
  • pressure on back that causes pain [ Time Frame: 10 hours after study start( 6 hours after the modality ends) ]

Central Contacts and Locations

Central contacts

jerrold S petrofsky, Ph D

7143215424jpetrofsky@outlook.com

Locations

Future Sciecne Technology

Recruiting

Henderson, Nevada, United States, 89113

More Information

Sponsor

Future Sciene Technology

Last update posted

Nov 14, 2018

Last verified

Nov, 2018

Keywords

  • heat
  • hot temperature
  • cutaneous electrostimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Future Sciene Technology on 2018-11-14.