TENS and Heat for Reducing Back Pain in Humans

Future Sciene Technology

Status: Unknown

Conditions: Pain

Treatments: Device: TENS; Device: sham Tens; Device: Thermacare heat wraps; Device: sham heat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03740750

jand m18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 24 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 6 patient groups, including a placebo group

control

Placebo Comparator group

Description:

sham heat and sham TENS

Treatment:

Device: sham Tens

Device: sham heat

heat only

Experimental group

Description:

heat applied to the back for 4 hours with sham TENS

Treatment:

Device: sham Tens

Device: Thermacare heat wraps

Tens only

Experimental group

Description:

Tens applied for 4 hours with sham heat

Treatment:

Device: TENS

Device: sham heat

Heat and Tens continuous

Experimental group

Description:

Heat and Tens applied together for 4 hours

Treatment:

Device: TENS

Device: Thermacare heat wraps

Tens 15

Experimental group

Description:

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

Treatment:

Device: TENS

Device: sham heat

Heat and Tens 15

Experimental group

Description:

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

Treatment:

Device: TENS

Device: Thermacare heat wraps