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Cryotherapy and TENS on Low Back Pain (CTLBP)

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ClinicalTrials.gov Identifier: NCT03248505
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte

Brief 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.


Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Device: Conventional TENS Device: Burst TENS Other: Cryotherapy Device: Burst TENS + Cryotherapy Device: Conventional TENS + Cryotherapy Other: Placebo TENS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3x6
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain
Actual Study Start Date : May 29, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Placebo Comparator: Placebo TENS
TENS unit turned on, but with zero amplitude.
Other: Placebo TENS
TENS device turned on, but with zero amplitude.
Other Name: Placebo

Experimental: Conventional TENS
Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude.
Device: Conventional TENS
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.
Other Name: Transcutaneous Electrical Nerve Stimulation

Experimental: Burst TENS
Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
Device: Burst TENS
Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
Other Name: Burst-modulated TENS

Experimental: Cryotherapy
1,5 Kg crushed ice pack
Other: Cryotherapy
1,5 Kg of crushed ice pack on lumbar spine.
Other Name: Ice

Experimental: Burst TENS + Cryotherapy
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
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.
Other Name: Burst-modulated TENS and Ice

Experimental: Conventional TENS + Cryotherapy
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
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.
Other Name: Transcutaneous Electrical Nerve Stimulation + Ice




Primary Outcome Measures :
  1. Painful sensation [ Time Frame: Evaluation of pain sensation 25 minutes after the application of the intervention. ]
    Pain sensation measured by pain numerical rating scale



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248505


Contacts
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Contact: Jamilson S Brasileiro, PhD +55 84 3342-2015 brasileiro@ufrnet.br

Locations
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Brazil
Federal University of Rio Grande do Norte Recruiting
Natal, RN, Brazil, 59140-840
Contact: Jamilson S Brasileiro, PhD    +55 84 3342-2008    brasileiro@ufrnet.br   
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte

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Responsible Party: Jamilson Simões Brasileiro, Professor of Physiotherapy, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT03248505     History of Changes
Other Study ID Numbers: TENS_LBP
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms