Clinical trial NCT04020861: Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients
Official title: Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: Electrophysical agents
Low-level laser therapy
TENS
Neck pain
Chronic pain
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-07-16
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity: Numerical Rating Scale (Pain NRS)
timeFrame: 2 weeks after randomization
Secondary outcomes:
measure: Pain intensity: Numerical Rating Scale (Pain NRS)
timeFrame: 6 weeks after randomization
measure: Pain intensity at movement: Numerical Rating Scale (Pain NRS)
timeFrame: 2 weeks after randomization
measure: Neck disability
timeFrame: 2 weeks after randomization
measure: Cervical range of motion
timeFrame: 2 weeks after randomization
measure: Pressure Pain Threshold
timeFrame: 2 weeks after randomization
measure: Pain temporal summation (TS)
timeFrame: 2 weeks after randomization
measure: Conditioned pain modulation (CPM)
timeFrame: 2 weeks after randomization
measure: Depressive symptoms
timeFrame: 2 weeks after randomization
measure: Pain catastrophizing
timeFrame: 2 weeks after randomization
measure: Change in patient perception of quality of life:12-Item Short-Form Health Survey (SF-12)
timeFrame: 2 weeks after randomization
measure: Analgesic intake
timeFrame: 2 weeks after randomization
measure: Global perceived effect (GPE)
timeFrame: 2 weeks and 6 weeks after randomization
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University São Carlos
state: SP
Study officials:
References:
citation: 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.