Myofascial Pain Syndromes Myalgia
Conditions
Interventions
This is a randomized, controlled, double-blind clinical trial with an initial methodological pilot phase involving approximately 12 participants in the initial stage, allocated in a 1:1 ratio to the H
n=6) and the Sham Control Group (SHAM
n=6). Participants allocated to the HILT group will receive high-intensity laser therapy applied to the affected upper trapezius muscle using a 1064-nm Q-switched Nd:YAG laser device. Participants all
however, no therapeutic laser energy will be delivered. The therapeutic protocol will consist of eight sessions, administered twice a week for four consecutive weeks. The laser will be applied to the
understanding of the questionnaires, tolerability of the HILT/SHAM intervention, adherence to treatment sessions, the effectiveness of the blinding procedures, the occurrence of adverse events, and th
Sponsors
Universidade Estadual do Oeste do Paraná (UNIOESTE)
Universidade Estadual do Oeste do Paraná (UNIOESTE)
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes; aged between 18 and 60 years; clinical diagnosis of myofascial pain syndrome of the upper trapezius muscle; presence of at least one active myofascial trigger point; ability to understand the study procedures; provision of written informed consent
Exclusion criteria
Exclusion criteria: Individuals with fibromyalgia; cervical radiculopathy; cervical myelopathy; symptomatic cervical disc herniation; previous cervical surgery; history of significant cervical trauma; severe rheumatic diseases; current or previous neoplasms in the area to be irradiated; local infections; open wounds or dermatological diseases in the cervical/trapezius region; pregnancy; photosensitive epilepsy; significant impairment of thermal or pain sensation; use of photosensitizing medications; recent use of trigger point injections, local anesthetics, or corticosteroids within the previous 6 months; physiotherapy; acupuncture; dry needling; other specific treatment for cervical myofascial pain within the previous 3 months; absolute contraindications to the use of HILT; inability to understand or respond to the assessment instruments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Protocol feasibility is expected to be demonstrated in individuals with myofascial pain syndrome of the upper trapezius muscle receiving high-intensity laser therapy. Feasibility will be assessed by monitoring participant recruitment, session adherence, intervention tolerability, questionnaire comprehension, occurrence of adverse events, effectiveness of blinding procedures, and adequacy of data collection instruments. Recruitment, adherence, and attrition rates, as well as the occurrence of adverse events and the operational feasibility of the protocol, will be analyzed. | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in pain intensity is expected, assessed using the Visual Analog Scale (VAS). Scores ranging from 0 to 10 points will be analyzed at baseline, immediately after the first treatment session, 48 hours after the first session, at the end of the therapeutic protocol, and at the 30-day follow-up, when performed.;An increase in pressure pain threshold is expected, assessed using pressure algometry applied to the active myofascial trigger point of the upper trapezius muscle. Mean values obtained at baseline, immediately after the first treatment session, 48 hours after the first session, at the end of the therapeutic protocol, and at the 30-day follow-up, when performed, will be analyzed.;An increase in cervical range of motion is expected, assessed using inclinometry during cervical flexion, extension, lateral flexion, and rotation movements. Mean values expressed in degrees obtained at baseline, immediately after the first treatment session, 48 hours after the first session, at the end of the therapeutic protocol, and at the 30-day follow-up, when performed, will be analyzed.;An increase in upper trapezius muscle strength is expected, assessed using handheld dynamometry during maximal isometric contraction. Mean values obtained at baseline, immediately after the first treatment session, 48 hours after the first session, at the end of the therapeutic protocol, and at the 30-day follow-up, when performed, will be analyzed.;Improvement in the biomechanical properties of the upper trapezius muscle is expected, assessed using the MyotonPRO device. Muscle tone, stiffness, elasticity, creep, and relaxation time obtained at baseline, immediately after the first treatment session, 48 hours after the first session, at the end of the therapeutic protocol, and at the 30-day follow-up, when performed, will be analyzed.;Changes in the surface temperature of the upper trapezius region are expected, assessed using infrared thermography. Mean temperature, maximum temperature, | — |
Countries
BR
Contacts
Public ContactVanessa Souza
Universidade Estadual do Oeste do Paraná (UNIOESTE)
Outcome results
None listed