Neck Pain Treatment Clinical Trial
Official title:
Immediate Effect of Irradiation With Low-level Laser Therapy on the Electromyographic Activity of the Upper Trapezius Muscles and the Level of Pain Among Patients With Non-specific Neck Pain: a Randomized, Double-blinded, Sham-controlled, Crossover Study
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | July 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - 18 to 40 years - Male and female volunteers - History of neck pain for a period of more than two months - Score ranging from 15 to 24 on the Neck Disability Index - Score ranging from three to seven points on an 11-point (range: 0 to 10) numerical rating scale (NRS) for perceived pain intensity Exclusion Criteria: - history of neurological disorders - neck surgery - chronic neck pain resulting from a traumatic incident - chronic musculoskeletal condition - medical diagnosis of fibromyalgia; systemic disease - connective tissue disorder - having undergone physical therapy use of analgesic, muscle relaxant. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Nove de Julho University | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nove de Julho | Daniela Aparecida Biasotto-Gonzalez, Fabiana Sarilho de Mendonc¸a, Marco Anto^nio Fumagalli, Paulo de Tarso Camilo de Camargo, Simone Aparecida Penimpedo Calamita |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 1 Year | No |
| Secondary | 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. | 1 Year | No |