Cryotherapy and TENS on Low Back Pain

Not Applicable

• Conditions: Low Back Pain, Mechanical
• Interventions: Device: Burst TENS; Device: Burst TENS + Cryotherapy; Device: Conventional TENS + Cryotherapy; Other: Placebo TENS; Other: Cryotherapy; Device: Conventional TENS

• Registration Number: NCT03248505
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-29
• Status Verified: 2017-08
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Last Update Submitted: 2017-08-09
• Study First Posted: 2017-08-14
• Last Update Posted: 2017-08-14
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Burst TENS	Burst TENS	Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
Burst TENS + Cryotherapy	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.
Conventional TENS + Cryotherapy	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.
Placebo TENS	Placebo TENS	TENS unit turned on, but with zero amplitude.
Cryotherapy	Cryotherapy	1,5 Kg crushed ice pack
Conventional TENS	Conventional TENS	Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude.

Primary Outcome Measures

Name	Time	Method
Painful sensation	Evaluation of pain sensation 25 minutes after the application of the intervention.	Pain sensation measured by pain numerical rating scale

Trial Locations

Locations (1)

Federal University of Rio Grande do Norte; 🇧🇷 Natal, RN, Brazil