Cryotherapy and TENS on Low Back Pain

Low Back Pain, Mechanical Clinical Trial

— CTLBP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03248505
• Other study ID #: TENS_LBP
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2017
• Last updated: August 9, 2017
• Start date: May 29, 2017
• Est. completion date: February 2018

Study information

• Verified date: August 2017
• Source: Universidade Federal do Rio Grande do Norte
• Contact: Jamilson S Brasileiro, PhD
• Phone: +55 84 3342-2015
• Email: brasileiro[@]ufrnet.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

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.
• 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:
• Cryotherapy
1,5 Kg of crushed ice pack on lumbar spine.

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.
• 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:
• Placebo TENS
TENS device turned on, but with zero amplitude.

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Norte	Natal	RN

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Painful sensation	Pain sensation measured by pain numerical rating scale	Evaluation of pain sensation 25 minutes after the application of the intervention.