Cryotherapy and TENS on Low Back Pain (CTLBP)

Universidade Federal do Rio Grande do Norte

Status: Unknown

Conditions: Low Back Pain, Mechanical

Treatments: Other: Cryotherapy; Device: Burst TENS + Cryotherapy; Device: Conventional TENS; Device: Burst TENS; Other: Placebo TENS; Device: Conventional TENS + Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03248505

TENS_LBP

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 6 patient groups, including a placebo group

Placebo TENS

Placebo Comparator group

Description:

TENS unit turned on, but with zero amplitude.

Treatment:

Other: Placebo TENS

Conventional TENS

Experimental group

Description:

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

Treatment:

Device: Conventional TENS

Burst TENS

Experimental group

Description:

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

Treatment:

Device: Burst TENS

Cryotherapy

Experimental group

Description:

1,5 Kg crushed ice pack

Treatment:

Other: Cryotherapy

Burst TENS + Cryotherapy

Experimental group

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.

Treatment:

Device: Burst TENS + Cryotherapy

Conventional TENS + Cryotherapy

Experimental group

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.

Treatment:

Device: Conventional TENS + Cryotherapy