NCT06009900

Safety and Efficacy of Low-intensity Laser Therapy in the Treatment of Chronic Musculoskeletal Pain

Safety and Efficacy of Low-intensity Laser Therapy in the Treatment of Chronic Musculoskeletal Pain: a Multicenter Randomized Controlled Trail

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 860 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, prospective, randomized, controlled research design. This study takes classic NSAIDs treatment as a control, and it will take patients' pain relief, functional improvement, sleep quality improvement, and adverse reactions as the main and secondary evaluation indicators to explore the safety and effectiveness of weak laser treatment of chronic musculoskeletal pain, determining the dominant disease in the treatment of Chronic pain.

Detailed description

Research purpose: Chronic musculoskeletal pain is the most common clinical Chronic pain. Non-steroidal drugs are the most commonly used therapeutic drugs, but their effects on improving the body function are limited. At present, the pain diagnosis and treatment guidelines recommend that non-drug treatment should be used as a first-line treatment measure. Low intensity laser therapy can alleviate chronic musculoskeletal pain through multiple effects such as anti-inflammatory, promoting blood circulation, and promoting tissue repair. However, a large number of high-quality clinical studies are still needed to confirm its effectiveness. In view of this, this study aims to investigate the safety and effectiveness of dual wavelength weak laser therapy for chronic musculoskeletal pain independently developed in China, in order to clarify the clinical application value of this technology. Research protocol: This study is an intervention study. The participants will be assigned to different treatment groups (drug therapy group or low intensity laser therapy) to receive corresponding treatment. At the end of treatment and 1, 2, and 3 months after treatment, the researchers will evaluate treatment efficacy through a questionnaire survey. This study will (1) compare the degree of pain relief, functional improvement, sleep quality, quality of daily life, and incidence of adverse reactions in patients with chronic musculoskeletal pain after receiving weak laser therapy and NSAIDs treatment; (2) study the analgesic effect of low intensity laser therapy on different types of chronic musculoskeletal pain, and determine the advantageous disease types for this treatment.

Conditions

• Pain, Chronic

Interventions

Type	Name	Description
DEVICE	Low intensity laser treatment	Low intensity laser treatment: Both patients and doctors wear goggles during the irradiation process. Using 810nm (infrared)/658nm (red) dual wavelength output for direct skin contact point irradiation, the maximum output power is 100mW (red)/60mW (infrared). Select the treatment site based on the patient's anatomical positioning (muscle and tendon attachment points, nerve distribution aggregation points) and/or pain points, and perform spot laser irradiation. Low intensity laser treatment process: Treat once a day for 15 minutes each time, with 5 consecutive days of treatment and 2 days of rest per week. The patient received a total of 3 weeks (15 times) of low intensity laser treatment.
DRUG	Non-steroidal drug (Celecoxib) group	Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.

Timeline

• Start date: 2023-09-01
• Primary completion: 2023-09-01
• Completion: 2024-12-21
• First posted: 2023-08-24
• Last updated: 2023-08-24

Locations

5 sites across 1 country: China