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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
860
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.
Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.
China Resources & WISCO General Hospital
Wuhan, Hubei, China
LinFen People's Hospital
Linfen, Shanxi, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Treatment effectiveness
At the end of treatment (day21), the pain NRS (0, no pain; 10, worst pain imaginable) of patients are collected. These data are used to calculate the percentage of the difference between them and pain NRS of patients before treatment, relative to the latter. Then, this study calculates the proportion of patients with a decrease in NRS score of ≥ 30% in total patients. This proportion is defined as the treatment effectiveness rate.
Time frame: the end of treatment (day21)
the proportion of patients with a decrease in NRS score of ≥ 30% 1 month after treatment
1 month after treatment, the pain NRS (0, no pain; 10, worst pain imaginable) of patients are collected. These data are used to calculate the percentage of the difference between them and pain NRS of patients before treatment, relative to the latter. Then, this study calculates the proportion of patients with a decrease in NRS score of ≥ 30% in total patients. This proportion is defined as the treatment effectiveness rate.
Time frame: 1 month after treatment
the proportion of patients with a decrease in NRS score of ≥ 30% 2 months after treatment
2 months after treatment, the pain NRS (0, no pain; 10, worst pain imaginable) of patients are collected. These data are used to calculate the percentage of the difference between them and pain NRS of patients before treatment, relative to the latter. Then, this study calculates the proportion of patients with a decrease in NRS score of ≥ 30% in total patients. This proportion is defined as the treatment effectiveness rate.
Time frame: 2 months after treatment
the proportion of patients with a decrease in NRS score of ≥ 30% 3 months after treatment
3 months after treatment, the pain NRS (0, no pain; 10, worst pain imaginable) of patients are collected. These data are used to calculate the percentage of the difference between them and pain NRS of patients before treatment, relative to the latter. Then, this study calculates the proportion of patients with a decrease in NRS score of ≥ 30% in total patients. This proportion is defined as the treatment effectiveness rate.
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Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Time frame: 3 months after treatment
the proportion of patients with a decrease in NRS score of ≥ 50% at the end of treatment
At the end of treatment (day21), the pain NRS (0, no pain; 10, worst pain imaginable) of patients are collected. These data are used to calculate the percentage of the difference between them and pain NRS of patients before treatment, relative to the latter. Then, this study calculates the proportion of patients with a decrease in NRS score of ≥ 50% in total patients. This proportion is defined as the treatment effectiveness rate.
Time frame: the end of treatment (day21)
the proportion of patients with a decrease in NRS score of ≥ 50% 1 month after treatment
1 month after treatment, the pain NRS (0, no pain; 10, worst pain imaginable) of patients are collected. These data are used to calculate the percentage of the difference between them and pain NRS of patients before treatment, relative to the latter. Then, this study calculates the proportion of patients with a decrease in NRS score of ≥ 50% in total patients. This proportion is defined as the treatment effectiveness rate.
Time frame: 1 month after treatment
the proportion of patients with a decrease in NRS score of ≥ 50% 2 months after treatment
2 months after treatment, the pain NRS (0, no pain; 10, worst pain imaginable) of patients are collected. These data are used to calculate the percentage of the difference between them and pain NRS of patients before treatment, relative to the latter. Then, this study calculates the proportion of patients with a decrease in NRS score of ≥ 50% in total patients. This proportion is defined as the treatment effectiveness rate.
Time frame: 2 months after treatment
the proportion of patients with a decrease in NRS score of ≥ 50% 3 months after treatment
3 months after treatment, the pain NRS (0, no pain; 10, worst pain imaginable) of patients are collected. These data are used to calculate the percentage of the difference between them and pain NRS of patients before treatment, relative to the latter. Then, this study calculates the proportion of patients with a decrease in NRS score of ≥ 50% in total patients. This proportion is defined as the treatment effectiveness rate.
Time frame: 3 months after treatment
NRS at the end of treatment (day21)
At the end of treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.
Time frame: the end of treatment (day21)
NRS 1 month after treatment
1 month after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.
Time frame: 1 month after treatment
NRS 2 months after treatment
2 months after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.
Time frame: 2 months after treatment
NRS 3 months after treatment
3 months after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.
Time frame: 3 months after treatment
BPI at the end of treatment (day21)
At the end of treatment, Brief Pain Inventory (BPI) (11-Point scale, 0 = does not interfere, 10 = completely interferes; Higher score = greater pain or interference of pain with activities, sleep, and negative mood.) is collected.
Time frame: the end of treatment (day21)
BPI 1 month after treatment
1 month after treatment, Brief Pain Inventory (BPI) (11-Point scale, 0 = does not interfere, 10 = completely interferes; Higher score = greater pain or interference of pain with activities, sleep, and negative mood.) is collected.
Time frame: 1 month after treatment
BPI 2 months after treatment
2 months after treatment, Brief Pain Inventory (BPI) (11-Point scale, 0 = does not interfere, 10 = completely interferes; Higher score = greater pain or interference of pain with activities, sleep, and negative mood.) is collected.
Time frame: 2 months after treatment
BPI 3 months after treatment
3 months after treatment, Brief Pain Inventory (BPI) (11-Point scale, 0 = does not interfere, 10 = completely interferes; Higher score = greater pain or interference of pain with activities, sleep, and negative mood.) is collected.
Time frame: 3 months after treatment
RMDQ at the end of treatment (day21)
At the end of treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.
Time frame: the end of treatment (day21)
RMDQ 1 month after treatment
1 month after treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.
Time frame: 1 month after treatment
RMDQ 2 months after treatment
2 months after treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.
Time frame: 2 months after treatment
RMDQ 3 months after treatment
3 months after treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.
Time frame: 3 months after treatment
PSQI 3 months after treatment
3 months after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.
Time frame: 3 months after treatment
PSQI 2 months after treatment
2 months after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.
Time frame: 2 months after treatment
PSQI 1 month after treatment
1 month after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.
Time frame: 1 month after treatment
PSQI at the end of treatment (day21)
At the end of treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.
Time frame: the end of treatment (day21)
EQ-5D at the end of treatment (day21)
At the end of treatment, EuroQoL-5D (EQ-5D) (Each item, 3 levels 1 = no problem, 2 = some problem, 3 = extreme problem. Range, 0 = worst imaginable, 100 best imaginable health state) is collected.
Time frame: the end of treatment (day21)
EQ-5D 1 month after treatment
1 month after treatment, EuroQoL-5D (EQ-5D) (Each item, 3 levels 1 = no problem, 2 = some problem, 3 = extreme problem. Range, 0 = worst imaginable, 100 best imaginable health state) is collected.
Time frame: 1 month after treatment
EQ-5D 2 months after treatment
2 months after treatment, EuroQoL-5D (EQ-5D) (Each item, 3 levels 1 = no problem, 2 = some problem, 3 = extreme problem. Range, 0 = worst imaginable, 100 best imaginable health state) is collected.
Time frame: 2 months after treatment
EQ-5D 3 months after treatment
3 months after treatment, EuroQoL-5D (EQ-5D) (Each item, 3 levels 1 = no problem, 2 = some problem, 3 = extreme problem. Range, 0 = worst imaginable, 100 best imaginable health state) is collected.
Time frame: 3 months after treatment
HADS 3 months after treatment
3 months after treatment, Hospital Anxiety and Depression Scale (HADS) (Total score can be used as a measure of global negative affect. Score 8 to 10 = mild, 11 to 15 = moderate, ≥ 16 = severe) is collected.
Time frame: 3 months after treatment
HADS 2 months after treatment
2 months after treatment, Hospital Anxiety and Depression Scale (HADS) (Total score can be used as a measure of global negative affect. Score 8 to 10 = mild, 11 to 15 = moderate, ≥ 16 = severe) is collected.
Time frame: 2 months after treatment
HADS 1 month after treatment
1 month after treatment, Hospital Anxiety and Depression Scale (HADS) (Total score can be used as a measure of global negative affect. Score 8 to 10 = mild, 11 to 15 = moderate, ≥ 16 = severe) is collected.
Time frame: 1 month after treatment
HADS at the end of treatment (day21)
At the end of treatment, Hospital Anxiety and Depression Scale (HADS) (Total score can be used as a measure of global negative affect. Score 8 to 10 = mild, 11 to 15 = moderate, ≥ 16 = severe) is collected.
Time frame: the end of treatment (day21)