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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.
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | sham heat and sham TENS |
|
| heat only | Experimental | heat applied to the back for 4 hours with sham TENS |
|
| Tens only | Experimental | Tens applied for 4 hours with sham heat |
|
| Heat and Tens continuous | Experimental | Heat and Tens applied together for 4 hours |
|
| Tens 15 | Experimental | Tens applied only 15 minutes each hour for 4 hours, sham heat |
|
| Heat and Tens 15 | Experimental | Heat applied for 4 hours with tens only applied the last 15 minutes of each hour |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermacare heat wraps | Device | low level continuous heat wrap |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jerrold S petrofsky, Ph D | Contact | 7143215424 | jpetrofsky@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Mike Laymon, PT, DSC | Future Science Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Future Sciecne Technology | Recruiting | Henderson | Nevada | 89113 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29381114 | Result | 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. | |
| 28282796 | Result | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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6 different interventions will be tested in parallel on 6 equivalent groups of subjects
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|
| TENS | Device | electrical stimulation |
|
| sham heat | Device | expended heat wrap |
|
| sham Tens | Device | tens applied but unit not turned on |
|
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) |
| 25419887 | Result | 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. |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |