Low Back Pain, MechanicalCTLBPNCT03248505
Cryotherapy and TENS on Low Back Pain
A study testing Conventional TENS, Burst TENS and Cryotherapy in people with Low Back Pain, Mechanical, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
This study aim analyze the immediate effects of conventional transcutaneous electrical nerve stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Conventional TENS, Burst TENS and Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 29 May 2017to Feb 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 50 years;
- Have chronic non-specific low back pain.
Who cannot join
- Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
- Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
- Fibromyalgia
- Corticosteroid treatment in the previous two weeks;
- Antiinflammatory treatment in the previous 24 hours;
- Contraindications to the use of Kinesio Taping (allergy or intolerance);
Show all 9Show fewer
- Score of three or less on Visual Analogue Scale of the first day;
- Pregnancy;
- Ice allergy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59140-840
Jamilson S Brasileiro, PhD, +55 84 3342-2008, brasileiro@ufrnet.br
About this study
Official title: Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain
This study aim analyze the immediate effects of conventional transcutaneous electrical nerve stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with non-specific low back pain.
All subjects will be submitted to an evaluation of the painful sensation, through the numerical rating scale, and pain threshold, through algometry, before, immediately after the intervention and 25 minutes after.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Conventional TENS, Burst TENS, Cryotherapy, Burst TENS + Cryotherapy, Conventional TENS + Cryotherapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TENSDevice
Also called Transcutaneous Electrical Nerve Stimulation
Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) with two electrodes in each side of the lumbar spinal.
Burst TENSDevice
Also called Burst-modulated TENS
Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
CryotherapyOther
Also called Ice
1,5 Kg of crushed ice pack on lumbar spine.
Burst TENS + CryotherapyDevice
Also called Burst-modulated TENS and Ice
Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus 1,5 Kg of crushed ice pack on lumbar spine.
Conventional TENS + CryotherapyDevice
Also called Transcutaneous Electrical Nerve Stimulation + Ice
Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) plus s 1,5 Kg of crushed ice pack on lumbar spine.
Placebo TENSOther
Also called Placebo
TENS device turned on, but with zero amplitude.
| Study group | Role | What they receive |
|---|---|---|
| Placebo TENS | Placebo comparator | TENS unit turned on, but with zero amplitude. Receives: Other: Placebo TENS |
| Conventional TENS | Experimental | Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude. Receives: Device: Conventional TENS |
| Burst TENS | Experimental | Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude. Receives: Device: Burst TENS |
| Cryotherapy | Experimental | 1,5 Kg crushed ice pack Receives: Other: Cryotherapy |
| Burst TENS + Cryotherapy | Experimental | Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus an ice pack of 1,5 Kg. Receives: Device: Burst TENS + Cryotherapy |
| Conventional TENS + Cryotherapy | Experimental | Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude plus an ice pack of 1,5 Kg. Receives: Device: Conventional TENS + Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Painful sensation
Pain sensation measured by pain numerical rating scale
Measured: Evaluation of pain sensation 25 minutes after the application of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start29 May 2017
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- 3x6
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248505
- Sponsor's protocol ID
- TENS_LBP
- Acronym
- CTLBP
- Status last verified
- Aug 2017
- First submitted
- 9 Aug 2017
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT03248505
- Acronym / sponsor ID
- CTLBP / TENS_LBP
- Conditions
- Low Back Pain, Mechanical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 14 Aug 2017 (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.
This study aim analyze the immediate effects of conventional transcutaneous electrical nerve stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with non-specific low back pain.
All subjects will be submitted to an evaluation of the painful sensation, through the numerical rating scale, and pain threshold, through algometry, before, immediately after the intervention and 25 minutes after.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 3x6
| Arm | Type | Receives |
|---|---|---|
| Placebo TENS | Placebo comparator | Other: Placebo TENSTENS unit turned on, but with zero amplitude. |
| Conventional TENS | Experimental | Device: Conventional TENSSymmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude. |
| Burst TENS | Experimental | Device: Burst TENSCarrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude. |
| Cryotherapy | Experimental | Other: Cryotherapy1,5 Kg crushed ice pack |
| Burst TENS + Cryotherapy | Experimental | Device: Burst TENS + CryotherapyCarrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus an ice pack of 1,5 Kg. |
| Conventional TENS + Cryotherapy | Experimental | Device: Conventional TENS + CryotherapySymmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude plus an ice pack of 1,5 Kg. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 18 and 50 years;
- Have chronic non-specific low back pain.
Key exclusion criteria (9 listed)
- Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
- Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
- Fibromyalgia
- Corticosteroid treatment in the previous two weeks;
- Antiinflammatory treatment in the previous 24 hours;
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 |
|---|---|---|
| Conventional TENSAlso: Transcutaneous Electrical Nerve StimulationTranscutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) with two electrodes in each side of the lumbar spinal. | Device | Conventional TENS |
| Burst TENSAlso: Burst-modulated TENSBurst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude. | Device | Burst TENS |
| CryotherapyAlso: Ice1,5 Kg of crushed ice pack on lumbar spine. | Other | Cryotherapy |
| Burst TENS + CryotherapyAlso: Burst-modulated TENS and IceBurst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus 1,5 Kg of crushed ice pack on lumbar spine. | Device | Burst TENS + Cryotherapy |
| Conventional TENS + CryotherapyAlso: Transcutaneous Electrical Nerve Stimulation + IceTranscutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) plus s 1,5 Kg of crushed ice pack on lumbar spine. | Device | Conventional TENS + Cryotherapy |
| Placebo TENSAlso: PlaceboTENS device turned on, but with zero amplitude. | Other | Placebo TENS |
Primary outcome
Painful sensation
Time frame: Evaluation of pain sensation 25 minutes after the application of the intervention.
Pain sensation measured by pain numerical rating scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional TENS, Burst TENS and Cryotherapy in people with Low Back Pain, Mechanical, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 9 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 Aug 2017. 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 Brazil. 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 Jamilson S Brasileiro, PhD (+55 84 3342-2015, brasileiro@ufrnet.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Painful sensation (time frame: Evaluation of pain sensation 25 minutes after the application of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2017.