Cryotherapy and TENS on Low Back Pain (CTLBP)

August 9, 2017 updated by: Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RN
      • Natal, RN, Brazil, 59140-840
        • Recruiting
        • Federal University of Rio Grande do Norte
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Burst-modulated TENS
Experimental: Cryotherapy
1,5 Kg crushed ice pack
Other: Cryotherapy
1,5 Kg of crushed ice pack on lumbar spine.
Other Names:
  • 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 Names:
  • 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 Names:
  • Transcutaneous Electrical Nerve Stimulation + Ice

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio Grande do Norte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TENS_LBP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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