PainNCT03740750
TENS and Heat for Reducing Back Pain in Humans
A study testing Thermacare heat wraps and TENS in people with Pain, run by Future Sciene Technology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Thermacare heat wraps and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- pain for at least 3 months in the lower back
- age range 24-60
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Future Sciecne Technology
Henderson, Nevada, 89113
jerrold petrofsky, ph d
About this study
Official title: 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
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.
Read the 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;
- 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.
- Conditions
- Pain
- Being tested
- Thermacare heat wraps, TENS, sham heat, sham Tens
- Keywords
- heat, hot temperature, cutaneous electrostimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermacare heat wrapsDevice
low level continuous heat wrap
TENSDevice
electrical stimulation
sham heatDevice
expended heat wrap
sham TensDevice
tens applied but unit not turned on
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | sham heat and sham TENS Receives: Device: sham heat; Device: sham Tens |
| heat only | Experimental | heat applied to the back for 4 hours with sham TENS Receives: Device: Thermacare heat wraps; Device: sham Tens |
| Tens only | Experimental | Tens applied for 4 hours with sham heat Receives: Device: TENS; Device: sham heat |
| Heat and Tens continuous | Experimental | Heat and Tens applied together for 4 hours Receives: Device: Thermacare heat wraps; Device: TENS |
| Tens 15 | Experimental | Tens applied only 15 minutes each hour for 4 hours, sham heat Receives: Device: TENS; Device: sham heat |
| Heat and Tens 15 | Experimental | Heat applied for 4 hours with tens only applied the last 15 minutes of each hour Receives: Device: Thermacare heat wraps; Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline (beginning of study before intervention)
pressure on back that causes pain
pressure applied to lower back until pain is felt to assess inflammation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 10 hours after study start( 6 hours after the modality ends)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start15 Oct 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6 different interventions will be tested in parallel on 6 equivalent groups of subjects
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future Sciene Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Laymon, PT, DSC, Study director, Future Science Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740750
- Sponsor's protocol ID
- jand m18
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 29381114Petrofsky 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.
PubMed 28282796Stark 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.
PubMed 25419887
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03740750
- Acronym / sponsor ID
- jand m18
- Conditions
- Pain
- Keywords
- heat, hot temperature, cutaneous electrostimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Future Sciene TechnologyIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 6 different interventions will be tested in parallel on 6 equivalent groups of subjects
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Device: sham heat, Device: sham Tenssham heat and sham TENS |
| heat only | Experimental | Device: Thermacare heat wraps, Device: sham Tensheat applied to the back for 4 hours with sham TENS |
| Tens only | Experimental | Device: TENS, Device: sham heatTens applied for 4 hours with sham heat |
| Heat and Tens continuous | Experimental | Device: Thermacare heat wraps, Device: TENSHeat and Tens applied together for 4 hours |
| Tens 15 | Experimental | Device: TENS, Device: sham heatTens applied only 15 minutes each hour for 4 hours, sham heat |
| Heat and Tens 15 | Experimental | Device: Thermacare heat wraps, Device: TENSHeat applied for 4 hours with tens only applied the last 15 minutes of each hour |
Who may qualify
- Ages
- 24 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pain for at least 3 months in the lower back
- age range 24-60
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermacare heat wrapslow level continuous heat wrap | Device | Heat and Tens 15, Heat and Tens continuous, heat only |
| TENSelectrical stimulation | Device | Heat and Tens 15, Heat and Tens continuous, Tens 15, Tens only |
| sham heatexpended heat wrap | Device | Tens 15, Tens only, control |
| sham Tenstens applied but unit not turned on | Device | control, heat only |
Primary outcome
range of motion of the hip for flexion, extension,left and right rotation,left and right bending
Time frame: Baseline (beginning of study before intervention)
range of motion in 6 degrees of freedom in the lower back
subjective pain by marking on scale
Time frame: 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
Time frame: Baseline (beginning of study before intervention)
pressure applied to lower back until pain is felt to assess inflammation
range of motion of the hip for flexion, extension,left and right rotation,left and right bending
Time frame: 4 hours after study start- at end of intervention
range of motion in 6 degrees of freedom in the lower back
subjective pain by marking on scale
Time frame: 4 hours after study start- at end of 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
Time frame: 4 hours after study start- at end of intervention
pressure applied to lower back until pain is felt to assess inflammation
range of motion of the hip for flexion, extension,left and right rotation,left and right bending
Time frame: 10 hours after study start( 6 hours after the modality ends)
range of motion in 6 degrees of freedom in the lower back
subjective pain by marking on scale
Time frame: 10 hours after study start( 6 hours after the modality ends)
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
Time frame: 10 hours after study start( 6 hours after the modality ends)
pressure applied to lower back until pain is felt to assess inflammation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Results publication: PubMed 29381114Petrofsky 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.
- Results publication: PubMed 28282796Petrofsky 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.
- Results publication: PubMed 25419887Stark 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Laymon, PT, DSC study director
Future Science Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermacare heat wraps and TENS in people with Pain, run by Future Sciene Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jerrold S petrofsky, Ph D (7143215424, jpetrofsky@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion of the hip for flexion, extension,left and right rotation,left and right bending (time frame: Baseline (beginning of study before intervention)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740750, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.