Cryotherapy and TENS on Low Back Pain

NCT03248505 | Unknown

• 1 other identifier: TENS_LBP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (1)

• Painful sensation

  Pain sensation measured by pain numerical rating scale

  Evaluation of pain sensation 25 minutes after the application of the intervention.

Study Arms (6)

Placebo TENS

PLACEBO COMPARATOR

TENS unit turned on, but with zero amplitude.

Other: Placebo TENS

Conventional TENS

EXPERIMENTAL

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

Device: Conventional TENS

Burst TENS

EXPERIMENTAL

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

Device: Burst TENS

Cryotherapy

EXPERIMENTAL

1,5 Kg crushed ice pack

Other: Cryotherapy

Burst TENS + Cryotherapy

EXPERIMENTAL

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

Conventional TENS + Cryotherapy

EXPERIMENTAL

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

Interventions

Conventional TENS DEVICE

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.

Also known as: Transcutaneous Electrical Nerve Stimulation

Conventional TENS

Burst TENS DEVICE

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

Also known as: Burst-modulated TENS

Burst TENS

Cryotherapy OTHER

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

Also known as: Ice

Cryotherapy

Burst TENS + Cryotherapy DEVICE

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.

Also known as: Burst-modulated TENS and Ice

Burst TENS + Cryotherapy

Conventional TENS + Cryotherapy DEVICE

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.

Also known as: Transcutaneous Electrical Nerve Stimulation + Ice

Conventional TENS + Cryotherapy

Placebo TENS OTHER

TENS device turned on, but with zero amplitude.

Also known as: Placebo

Placebo TENS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 50 years;
• Have chronic non-specific low back pain.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59140-840, Brazil

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Cryotherapy; Ice

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Central Study Contacts

Jamilson S Brasileiro, PhD

CONTACT

+55 84 3342-2015; brasileiro@ufrnet.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiotherapy

Model Details: 3x6

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 14, 2017
• Study Start: May 29, 2017
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

BR (1)