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Cryotherapy and TENS on Low Back Pain

NCT03248505 — Not applicable, Unknown, 120 participants, Universidade Federal do Rio Grande do Norte
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Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain

RegistryNCT03248505, acronym CTLBP
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment120 (Estimated)
SponsorUniversidade Federal do Rio Grande do Norte (Other)
ConditionsLow Back Pain, Mechanical
InterventionsConventional TENS, Burst TENS, Cryotherapy, Burst TENS + Cryotherapy, Conventional TENS + Cryotherapy, Placebo TENS (Device, other)
Datesstart 2017-05-29, primary completion 2017-12-01 (estimated), completion 2018-02-01 (estimated), first posted 2017-08-14, last updated 2017-08-14
Locations1 site in Brazil

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-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.

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Placebo TENSPlacebo comparatorOther: Placebo TENSTENS unit turned on, but with zero amplitude.
Conventional TENSExperimentalDevice: Conventional TENSSymmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude.
Burst TENSExperimentalDevice: Burst TENSCarrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
CryotherapyExperimentalOther: Cryotherapy1,5 Kg crushed ice pack
Burst TENS + CryotherapyExperimentalDevice: 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 + CryotherapyExperimentalDevice: 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.
  • Conventional TENS (Device), also known as 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 TENS (Device), also known as 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.
  • Cryotherapy (Other), also known as Ice: 1,5 Kg of crushed ice pack on lumbar spine.
  • Burst TENS + Cryotherapy (Device), also known as 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 + Cryotherapy (Device), also known as 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 TENS (Other), also known as Placebo: TENS device turned on, but with zero amplitude.

+Outcome measures

Primary outcomes

  • Painful sensation [Evaluation of pain sensation 25 minutes after the application of the intervention.]: Pain sensation measured by pain numerical rating scale

+Eligibility

Sex: All, ages: 18 Years to 50 Years

Inclusion Criteria:

* Aged between 18 and 50 years;
* Have chronic non-specific low back pain.

Exclusion Criteria:

* 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);
* Score of three or less on Visual Analogue Scale of the first day;
* Pregnancy;
* Ice allergy.

+Locations (1)

FacilityCityCountryStatus
Federal University of Rio Grande do NorteNatal, Rio Grande do NorteBrazilRecruiting

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