Clinical trial NCT06009900: Safety and Efficacy of Low-intensity Laser Therapy in the Treatment of Chronic Musculoskeletal Pain
Official title: Safety and Efficacy of Low-intensity Laser Therapy in the Treatment of Chronic Musculoskeletal Pain: a Multicenter Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Chronic
Keywords: Chronic musculoskeletal pain
Low intensity laser therapy
Non-steroidal drugs
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Shanxi Bethune Hospital
name: Second Hospital of Shanxi Medical University
name: Shanxi Provincial People's Hospital
name: China Resources WISCO General Hospital
name: LinFen People's Hospital
First posted: 2023-08-24
Enrollment: 860
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old;
2. Chronic musculoskeletal pain (including cervical spondylosis, periarthritis of shoulder, osteoarthritis, back muscle Fasciitis, lumbar disc herniation) was diagnosed, and the pain lasted for more than 3 months;
3. The degree of pain before treatment was mild to moderate (NRS score\<7 points);
4. Can cooperate in completing consultation and scale evaluation;
5. Sign an informed consent form.

Exclusion Criteria:

1. Previous spinal surgery or severe spinal diseases (such as fractures, tumors, inflammation, and infectious diseases);
2. Suffering from serious systemic diseases, including liver and kidney dysfunction, cardio cerebral, vascular disease, decompensated metabolic syndrome;
3. Serious skin diseases (skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis, lupus, Hives);
4. Suffering from mental disorders, intellectual disabilities, epilepsy and other diseases;
5. Moderate to severe depressive state;
6. Have a history of drug abuse, drug abuse, and alcohol abuse;
7. Individuals with contraindications to NSAIDs or laser therapy;
8. Pregnant women;
9. Recently participated in other clinical studies.

Primary outcomes:
measure: Treatment effectiveness
timeFrame: the end of treatment (day21)
Secondary outcomes:
measure: the proportion of patients with a decrease in NRS score of ≥ 30% 1 month after treatment
timeFrame: 1 month after treatment
measure: the proportion of patients with a decrease in NRS score of ≥ 30% 2 months after treatment
timeFrame: 2 months after treatment
measure: the proportion of patients with a decrease in NRS score of ≥ 30% 3 months after treatment
timeFrame: 3 months after treatment
measure: the proportion of patients with a decrease in NRS score of ≥ 50% at the end of treatment
timeFrame: the end of treatment (day21)
measure: the proportion of patients with a decrease in NRS score of ≥ 50% 1 month after treatment
timeFrame: 1 month after treatment
measure: the proportion of patients with a decrease in NRS score of ≥ 50% 2 months after treatment
timeFrame: 2 months after treatment
measure: the proportion of patients with a decrease in NRS score of ≥ 50% 3 months after treatment
timeFrame: 3 months after treatment
measure: NRS at the end of treatment (day21)
timeFrame: the end of treatment (day21)
measure: NRS 1 month after treatment
timeFrame: 1 month after treatment
measure: NRS 2 months after treatment
timeFrame: 2 months after treatment
measure: NRS 3 months after treatment
timeFrame: 3 months after treatment
measure: BPI at the end of treatment (day21)
timeFrame: the end of treatment (day21)
measure: BPI 1 month after treatment
timeFrame: 1 month after treatment
measure: BPI 2 months after treatment
timeFrame: 2 months after treatment
measure: BPI 3 months after treatment
timeFrame: 3 months after treatment
measure: RMDQ at the end of treatment (day21)
timeFrame: the end of treatment (day21)
measure: RMDQ 1 month after treatment
timeFrame: 1 month after treatment
measure: RMDQ 2 months after treatment
timeFrame: 2 months after treatment
measure: RMDQ 3 months after treatment
timeFrame: 3 months after treatment
measure: PSQI 3 months after treatment
timeFrame: 3 months after treatment
measure: PSQI 2 months after treatment
timeFrame: 2 months after treatment
measure: PSQI 1 month after treatment
timeFrame: 1 month after treatment
measure: PSQI at the end of treatment (day21)
timeFrame: the end of treatment (day21)
measure: EQ-5D at the end of treatment (day21)
timeFrame: the end of treatment (day21)
measure: EQ-5D 1 month after treatment
timeFrame: 1 month after treatment
measure: EQ-5D 2 months after treatment
timeFrame: 2 months after treatment
measure: EQ-5D 3 months after treatment
timeFrame: 3 months after treatment
measure: HADS 3 months after treatment
timeFrame: 3 months after treatment
measure: HADS 2 months after treatment
timeFrame: 2 months after treatment
measure: HADS 1 month after treatment
timeFrame: 1 month after treatment
measure: HADS at the end of treatment (day21)
timeFrame: the end of treatment (day21)
Other outcomes:
measure: Adverse reactions
timeFrame: during treatment (From start of treatment until the end of treatment or date when patient cannot continue the current treatment, whichever came first, assessed up to 21 days)
measure: Adverse reactions
timeFrame: the end of treatment (day21)
measure: Adverse reactions
timeFrame: 1 month after treatment
measure: Adverse reactions
timeFrame: 2 months after treatment
measure: Adverse reactions
timeFrame: 3 months after treatment
measure: NRS before treatment
timeFrame: before treatment
measure: BPI before treatment
timeFrame: before treatment
measure: RMDQ before treatment
timeFrame: before treatment
measure: PSQI before treatment
timeFrame: before treatment
measure: EQ-5D before treatment
timeFrame: before treatment
measure: HADS before treatment
timeFrame: before treatment
measure: Patient basic information
timeFrame: before treatment
Locations:
city: Wuhan
country: China
facility: China Resources & WISCO General Hospital
state: Hubei
city: Linfen
country: China
facility: LinFen People's Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
Study officials:
References: