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

Universidade Federal de Sao Carlos

Status: Completed

Conditions: Chronic Neck Pain

Treatments: Device: Placebo PBM; Device: Placebo TENS; Device: Active TENS; Device: Active PBM

Study type: Interventional

Funder types: Other

Identifiers

NCT04020861

CAAE: 81711417.0.0000.5504

Details and patient eligibility

About

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

Full description

Non-specific chronic neck pain patients will be treated with low-level laser therapy and/or trancutaneous electricam nerve stimulation. They will receive 10 sessions of treatment. Before and after the treatment physical measures and psychosocial factors will be evaluted to verificy the efficay these electrophysical agents.

Enrollment: 144 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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144 participants in 4 patient groups, including a placebo group

PBM + TENS

Active Comparator group

Description:

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

Treatment:

Device: Active TENS

Device: Active PBM

PBM

Active Comparator group

Description:

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

Treatment:

Device: Placebo TENS

Device: Active PBM

TENS

Active Comparator group

Description:

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

Treatment:

Device: Placebo PBM

Device: Active TENS

Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo PBM

Device: Placebo TENS