Pain, Chronic Clinical Trial
Official title:
Safety and Efficacy of Low-intensity Laser Therapy in the Treatment of Chronic Musculoskeletal Pain: a Multicenter Randomized Controlled Trail
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.
Status | Not yet recruiting |
Enrollment | 860 |
Est. completion date | December 21, 2024 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | LinFen People's Hospital | Linfen | Shanxi |
China | Second Hospital of Shanxi Medical University | Taiyuan | Shanxi |
China | Shanxi Bethune Hospital | Taiyuan | Shanxi |
China | Shanxi Provincial People's Hospital | Taiyuan | Shanxi |
China | China Resources & WISCO General Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital | China Resources WISCO General Hospital, LinFen People's Hospital, Second Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Provincial People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse reactions | Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage | 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) | |
Other | Adverse reactions | Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage | the end of treatment (day21) | |
Other | Adverse reactions | Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage | 1 month after treatment | |
Other | Adverse reactions | Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage | 2 months after treatment | |
Other | Adverse reactions | Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage | 3 months after treatment | |
Other | NRS before treatment | Before treatment, pain NRS (0, no pain; 10, worst pain imaginable) is collected. | before treatment | |
Other | BPI before treatment | Before treatment, 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. | before treatment | |
Other | RMDQ before treatment | Before treatment, RMDQ (Scores 0 to 24, higher score, indicates greater activity limitation) is collected. | before treatment | |
Other | PSQI before treatment | Before treatment, PSQI (Higher score = better sleep quality) is collected. | before treatment | |
Other | EQ-5D before treatment | Before treatment, 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. | before treatment | |
Other | HADS before treatment | Before treatment, 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. | before treatment | |
Other | Patient basic information | Patient basic information includes gender, age, marital status, education level (high school and below, university, graduate), occupational status (employment/education/retirement), height, weight, BMI, smoking history, and past history; Clinical characteristics related to the disease include history of low back pain (time of Chronic pain (years), number of acute attacks, time of this attack), and history of treatment of low back pain | before treatment | |
Primary | 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. | the end of treatment (day21) | |
Secondary | 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. | 1 month after treatment | |
Secondary | 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. | 2 months after treatment | |
Secondary | 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. | 3 months after treatment | |
Secondary | 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. | the end of treatment (day21) | |
Secondary | 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. | 1 month after treatment | |
Secondary | 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. | 2 months after treatment | |
Secondary | 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. | 3 months after treatment | |
Secondary | 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. | the end of treatment (day21) | |
Secondary | NRS 1 month after treatment | 1 month after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected. | 1 month after treatment | |
Secondary | NRS 2 months after treatment | 2 months after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected. | 2 months after treatment | |
Secondary | NRS 3 months after treatment | 3 months after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected. | 3 months after treatment | |
Secondary | 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. | the end of treatment (day21) | |
Secondary | 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. | 1 month after treatment | |
Secondary | 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. | 2 months after treatment | |
Secondary | 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. | 3 months after treatment | |
Secondary | 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. | the end of treatment (day21) | |
Secondary | 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. | 1 month after treatment | |
Secondary | 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. | 2 months after treatment | |
Secondary | 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. | 3 months after treatment | |
Secondary | PSQI 3 months after treatment | 3 months after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected. | 3 months after treatment | |
Secondary | PSQI 2 months after treatment | 2 months after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected. | 2 months after treatment | |
Secondary | PSQI 1 month after treatment | 1 month after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected. | 1 month after treatment | |
Secondary | PSQI at the end of treatment (day21) | At the end of treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected. | the end of treatment (day21) | |
Secondary | 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. | the end of treatment (day21) | |
Secondary | 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. | 1 month after treatment | |
Secondary | 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. | 2 months after treatment | |
Secondary | 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. | 3 months after treatment | |
Secondary | 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. | 3 months after treatment | |
Secondary | 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. | 2 months after treatment | |
Secondary | 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. | 1 month after treatment | |
Secondary | 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. | the end of treatment (day21) |
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