Cryotherapy and TENS on Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain

Conditions
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Low Back Pain, Mechanical

Intervention / Treatment
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* Device: Conventional TENS
* Device: Burst TENS
* Other: Cryotherapy
* Device: Burst TENS + Cryotherapy
* Device: Conventional TENS + Cryotherapy
* Other: Placebo TENS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3x6
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo TENS<br>TENS unit turned on, but with zero amplitude. | Other: Placebo TENS<br>* TENS device turned on, but with zero amplitude.<br>* Other names: Placebo;|
| Experimental: Conventional TENS<br>Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude. | Device: Conventional TENS<br>* 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.<br>* Other names: Transcutaneous Electrical Nerve Stimulation;|
| Experimental: Burst TENS<br>Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude. | Device: Burst TENS<br>* Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.<br>* Other names: Burst-modulated TENS;|
| Experimental: Cryotherapy<br>1,5 Kg crushed ice pack | Other: Cryotherapy<br>* 1,5 Kg of crushed ice pack on lumbar spine.<br>* Other names: Ice;|
| Experimental: Burst TENS + Cryotherapy<br>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. | Device: Burst TENS + Cryotherapy<br>* 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.<br>* Other names: Burst-modulated TENS and Ice;|
| Experimental: Conventional TENS + Cryotherapy<br>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. | Device: Conventional TENS + Cryotherapy<br>* 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.<br>* Other names: Transcutaneous Electrical Nerve Stimulation + Ice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Painful sensation | Pain sensation measured by pain numerical rating scale | Evaluation of pain sensation 25 minutes after the application of the intervention. |