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Cryotherapy and TENS on Low Back Pain (CTLBP)

Primary Purpose

Low Back Pain, Mechanical

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Conventional TENS
Burst TENS
Cryotherapy
Burst TENS + Cryotherapy
Conventional TENS + Cryotherapy
Placebo TENS
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of Rio Grande do NorteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo TENS

Conventional TENS

Burst TENS

Cryotherapy

Burst TENS + Cryotherapy

Conventional TENS + Cryotherapy

Arm Description

TENS unit turned on, but with zero amplitude.

Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude.

Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.

1,5 Kg crushed ice pack

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.

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.

Outcomes

Primary Outcome Measures

Painful sensation
Pain sensation measured by pain numerical rating scale

Secondary Outcome Measures

Full Information

First Posted
August 9, 2017
Last Updated
August 9, 2017
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03248505
Brief Title
Cryotherapy and TENS on Low Back Pain
Acronym
CTLBP
Official Title
Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3x6
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo TENS
Arm Type
Placebo Comparator
Arm Description
TENS unit turned on, but with zero amplitude.
Arm Title
Conventional TENS
Arm Type
Experimental
Arm Description
Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude.
Arm Title
Burst TENS
Arm Type
Experimental
Arm Description
Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
Arm Title
Cryotherapy
Arm Type
Experimental
Arm Description
1,5 Kg crushed ice pack
Arm Title
Burst TENS + Cryotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional TENS + Cryotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional TENS
Other Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Burst TENS
Other Intervention Name(s)
Burst-modulated TENS
Intervention Description
Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
Intervention Type
Other
Intervention Name(s)
Cryotherapy
Other Intervention Name(s)
Ice
Intervention Description
1,5 Kg of crushed ice pack on lumbar spine.
Intervention Type
Device
Intervention Name(s)
Burst TENS + Cryotherapy
Other Intervention Name(s)
Burst-modulated TENS and Ice
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional TENS + Cryotherapy
Other Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation + Ice
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo TENS
Other Intervention Name(s)
Placebo
Intervention Description
TENS device turned on, but with zero amplitude.
Primary Outcome Measure Information:
Title
Painful sensation
Description
Pain sensation measured by pain numerical rating scale
Time Frame
Evaluation of pain sensation 25 minutes after the application of the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamilson S Brasileiro, PhD
Phone
+55 84 3342-2015
Email
brasileiro@ufrnet.br
Facility Information:
Facility Name
Federal University of Rio Grande do Norte
City
Natal
State/Province
RN
ZIP/Postal Code
59140-840
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamilson S Brasileiro, PhD
Phone
+55 84 3342-2008
Email
brasileiro@ufrnet.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Cryotherapy and TENS on Low Back Pain

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