Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients

NCT04020861 | Completed

• 1 other identifier: CAAE: 81711417.0.0000.5504
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy isolated and combinaded of photobiomodulation therapy with low level laser therapy and the transcutaneous electrical nerve stimulation.

Conditions

Chronic Neck Pain

Keywords

Electrophysical agents; Low-level laser therapy; TENS; Neck pain; Chronic pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity: Numerical Rating Scale (Pain NRS)

  Pain intensity will be evaluated using an 11-point (0-10) Numerical Rating Scale (Pain NRS), which is a simple and easy-to-use measuring scale that consists of a sequence of numbers from zero to 10, in which zero represents "no pain" and 10 represents "the worst pain imaginable". The pain evaluation will be carried out verbally with the patient reporting the pain intensity.

  2 weeks after randomization

Secondary Outcomes (12)

• Pain intensity: Numerical Rating Scale (Pain NRS)

  6 weeks after randomization

• Pain intensity at movement: Numerical Rating Scale (Pain NRS)

  2 weeks after randomization

• Neck disability

  2 weeks after randomization

• Cervical range of motion

  2 weeks after randomization

• Pressure Pain Threshold

  2 weeks after randomization

Study Arms (4)

PBM + TENS

ACTIVE COMPARATOR

The patients will be submitted to the active PBM and active TENS

Device: Active PBM; Device: Active TENS

PBM

ACTIVE COMPARATOR

The patients will be submitted to the active PBMT and placebo TENS

Device: Active PBM; Device: Placebo TENS

TENS

ACTIVE COMPARATOR

The patients will be submitted to the placebo PBMT and active TENS

Device: Active TENS; Device: Placebo PBM

Placebo

PLACEBO COMPARATOR

The patients will be submitted to the placebo PBMT and placebo TENS.

Device: Placebo PBM; Device: Placebo TENS

Interventions

Active PBM DEVICE

To active photobiomodulation therapy (PBMT) the patient will be oriented to lie preferably in prone. The treatment area will be defined according to painful area. In the active group will be used the followings parameters: low-level laser therapy, 808 nm, 4 infrared diodes, 180 mW, 9 J. In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.

PBM; PBM + TENS

Active TENS DEVICE

To active transcutaneous electrical nerve stimulation (TENS) the patient will be oriented to lie preferably in prone. Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. It will be used the following parameters: frequency of 100 Hz, pulse duration of 125 µs (positive phase), 30 minutes of current stimulation and the pulse amplitude will be increased until the patient reports a strong but comfortable paresthesia (including motor level stimulation but no painful TENS). The amplitude will be adjusted (if necessary) each 5 minutes to keep a strong but comfortable paresthesia.

PBM + TENS; TENS

Placebo PBM DEVICE

In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.

Placebo; TENS

Placebo TENS DEVICE

To placebo transcutaneous electrical nerve stimulation (TENS) Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. This device was customized to deliver a current for 30 seconds (both channels) and then ramp off over the next 15 seconds so that it will be active for a total of 45 seconds. This will permit the patient to fell the TENS sensation while applying the settings.

PBM; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-specific chronic neck pain, defined as pain or discomfort in the posterior cervical region between the superior nuchal line and the first thoracic spinous process and / or shoulder girdle;
• Neck pain for at least 3 months;
• Neck Disability Index (NDI) score of 5 points or higher;
• Numeric Rating Scale (NRS) score of 3 or higher to pain intensity;
• Aged between 18 and 65 years;
• Men and women

You may not qualify if:

• Neck pain associated with nerve root compromise (measured by clinical examination of dermatomes, myotomes and reflexes);
• Previous spinal surgery;
• Patients treated with physical therapy for neck pain in the last 3 months previous the study;
• Severe spinal disorders such as fractures, tumors, inflammatory and infectious diseases;
• Any contraindication to low level laser therapy or transcutaneous electrical nerve stimulation;
• Rheumatic, metabolic, neurological or cardiopulmonary diseases;
• Patients who require artificial cardiac pacemakers;
• Skin diseases, mainly at the current application site;
• Tumors or cancer historic in the last 5 years;
• Pregnancy;
• If the patient started any physical activity in the last 2 weeks.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal University São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

Related Publications (1)

• Rampazo EP, de Andrade ALM, da Silva VR, Back CGN, Liebano RE. Photobiomodulation therapy and transcutaneous electrical nerve stimulation on chronic neck pain patients: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19191. doi: 10.1097/MD.0000000000019191.

  PMID: 32080103 DERIVED

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 16, 2019
• Study Start: January 6, 2020
• Primary Completion: June 25, 2021
• Study Completion: July 25, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

BR (1)