A Phase 1/2 interventional study of low level laser therapy and Placebo low level laser therapy in Neck Pain Treatment, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2015-07-15.
Sponsored by University of Nove de Julho · Phase 1/2, Interventional, and Treatment
The aim of the present study is to assess the immediate effect of irradiation with low level laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients with non-specific neck pain will be enrolled in a randomized, single-blind, crossover study. Each subject will receive two forms of treatment in random order: a single session of LLLT and placebo LLLT. In order to eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine nerve conduction velocity and activity in the upper trapezius muscles before and after treatment. The outcome measures will be determined by a numerical pain rating scale. Comparisons before and after irradiation with LLLT will determine the activity of the upper trapezius muscles and the level of pain. The data will be submitted to statistical tests considering a p-value of p \< 0.05.
1,231 studies on the registry are indexed under Neck Pain; 254 are open to participants now.
This study's enrollment of 20 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
For the LLLT irradiation, a paper template with 9 points (area of 1cm and a distance from center to center of 1 cm) will be used, distributed in three columns and three lines. The central point of the template will be positioned above the medium point of a line traced between the acromion and the spinous process of the seventh cervical vertebra, where the treatment should be close to the fixation point of the EMG electrode. The application point of the LLLT was determined by the location of the innervation point of the upper trapezius muscle. Individuals will be subject to application of low level laser with a total dose of 18 J
Device: low level laser therapy
For the PLLLT irradiation, a paper template with 9 points (area of 1cm and a distance from center to center of 1 cm) will be used, distributed in three columns and three lines. The central point of the template will be positioned above the medium point of a line traced between the acromion and the spinous process of the seventh cervical vertebra, where the treatment should be close to the fixation point of the EMG electrode. The application point of the PLLLT was determined by the location of the innervation point of the upper trapezius muscle. Individuals will be subject to application of low level laser with a total dose of 0 J
Device: Placebo low level laser therapy
Will be performed irradiation with low-intensity laser in upper trapezius muscle
Will be not performed irradiation with low-intensity laser in upper trapezius muscle
Electromyographic activity
The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment.
Time frame: 1 Year
Numerical rating scale score for pain
A numerical rating scale for pain will be used to assess pain intensity in the NS-NP individuals. This is an 11-point scale ranging from 0 (absence of pain) to 10 (worst possible pain). The numerical rating scale was translated and cross-culturally adapted for the Brazilian population.
Time frame: 1 Year
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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University of Nove de Julho