TENS and Heat for Reducing Back Pain in Humans

NCT ID: NCT03740750

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2018-12-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control

sham heat and sham TENS

Group Type: PLACEBO_COMPARATOR

sham heat

Intervention Type: DEVICE

expended heat wrap

sham Tens

Intervention Type: DEVICE

tens applied but unit not turned on

heat only

heat applied to the back for 4 hours with sham TENS

Group Type: EXPERIMENTAL

Thermacare heat wraps

Intervention Type: DEVICE

low level continuous heat wrap

sham Tens

Intervention Type: DEVICE

tens applied but unit not turned on

Tens only

Tens applied for 4 hours with sham heat

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

electrical stimulation

sham heat

Intervention Type: DEVICE

expended heat wrap

Heat and Tens continuous

Heat and Tens applied together for 4 hours

Group Type: EXPERIMENTAL

Thermacare heat wraps

Intervention Type: DEVICE

low level continuous heat wrap

TENS

Intervention Type: DEVICE

electrical stimulation

Tens 15

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

Group Type: EXPERIMENTAL

TENS

Intervention Type: DEVICE

electrical stimulation

sham heat

Intervention Type: DEVICE

expended heat wrap

Heat and Tens 15

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

Group Type: EXPERIMENTAL

Thermacare heat wraps

Intervention Type: DEVICE

low level continuous heat wrap

TENS

Intervention Type: DEVICE

electrical stimulation

Interventions

Thermacare heat wraps

low level continuous heat wrap

Intervention Type: DEVICE

TENS

electrical stimulation

Intervention Type: DEVICE

sham heat

expended heat wrap

Intervention Type: DEVICE

sham Tens

tens applied but unit not turned on

Intervention Type: DEVICE

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Future Sciene Technology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike Laymon, PT, DSC

Role: STUDY_DIRECTOR

Future Science Technology

Locations

Future Sciecne Technology

Henderson, Nevada, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

jerrold S petrofsky, Ph D

Role: CONTACT

jpetrofsky@outlook.com

7143215424

Facility Contacts

jerrold petrofsky, ph d

Role: primary

References

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.

Reference Type: RESULT

PMID: 29381114 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28282796 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25419887 (View on PubMed)

Other Identifiers

jand m18

Identifier Type: -

Identifier Source: org_study_id