TENS and Heat for Reducing Back Pain in Humans

Study Overview
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Brief Summary
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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
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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; Control heat only Tens only Tens and heat Tens for the last 15 minutes each hour plus heat 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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Device: Thermacare heat wraps
* Device: TENS
* Device: sham heat
* Device: sham Tens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pain for at least 3 months in the lower back age range 24-60 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 6 different interventions will be tested in parallel on 6 equivalent groups of subjects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>sham heat and sham TENS | Device: sham heat<br>* expended heat wrap<br>Device: sham Tens<br>* tens applied but unit not turned on<br>|
| Experimental: heat only<br>heat applied to the back for 4 hours with sham TENS | Device: Thermacare heat wraps<br>* low level continuous heat wrap<br>Device: sham Tens<br>* tens applied but unit not turned on<br>|
| Experimental: Tens only<br>Tens applied for 4 hours with sham heat | Device: TENS<br>* electrical stimulation<br>Device: sham heat<br>* expended heat wrap<br>|
| Experimental: Heat and Tens continuous<br>Heat and Tens applied together for 4 hours | Device: Thermacare heat wraps<br>* low level continuous heat wrap<br>Device: TENS<br>* electrical stimulation<br>|
| Experimental: Tens 15<br>Tens applied only 15 minutes each hour for 4 hours, sham heat | Device: TENS<br>* electrical stimulation<br>Device: sham heat<br>* expended heat wrap<br>|
| Experimental: Heat and Tens 15<br>Heat applied for 4 hours with tens only applied the last 15 minutes of each hour | Device: Thermacare heat wraps<br>* low level continuous heat wrap<br>Device: TENS<br>* electrical stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heat, hot temperature, cutaneous electrostimulation