Pain
Conditions
Keywords
heat, hot temperature, cutaneous electrostimulation
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.
Interventions
DEVICEThermacare heat wraps
low level continuous heat wrap
DEVICETENS
electrical stimulation
DEVICEsham heat
expended heat wrap
DEVICEsham Tens
tens applied but unit not turned on
Sponsors
Future Sciene Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
6 different interventions will be tested in parallel on 6 equivalent groups of subjects
Eligibility
Sex/Gender
ALL
Age
24 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| range of motion of the hip for flexion, extension,left and right rotation,left and right bending | Baseline (beginning of study before intervention) | range of motion in 6 degrees of freedom in the lower back |
| subjective pain by marking on scale | Baseline (beginning of study before intervention) | analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst |
| pressure on back that causes pain | Baseline (beginning of study before intervention) | pressure applied to lower back until pain is felt to assess inflammation |
Countries
United States
Contacts
Primary Contactjerrold S petrofsky, Ph D
Outcome results
None listed