xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06009900</url>
    </required_header>
    <id_info>
      <org_study_id>TJ-IRB20230796</org_study_id>
      <nct_id>NCT06009900</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of Low-intensity Laser Therapy in the Treatment of Chronic Musculoskeletal Pain</brief_title>
    <official_title>Safety and Efficacy of Low-intensity Laser Therapy in the Treatment of Chronic Musculoskeletal Pain: a Multicenter Randomized Controlled Trail</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tongji Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shanxi Bethune Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Second Hospital of Shanxi Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanxi Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>China Resources WISCO General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>LinFen People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tongji Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a multicenter, prospective, randomized, controlled research design. This study&#xD;
        takes classic NSAIDs treatment as a control, and it will take patients' pain relief,&#xD;
        functional improvement, sleep quality improvement, and adverse reactions as the main and&#xD;
        secondary evaluation indicators to explore the safety and effectiveness of weak laser&#xD;
        treatment of chronic musculoskeletal pain, determining the dominant disease in the treatment&#xD;
        of Chronic pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Research purpose:&#xD;
  &#xD;
        Chronic musculoskeletal pain is the most common clinical Chronic pain. Non-steroidal drugs&#xD;
        are the most commonly used therapeutic drugs, but their effects on improving the body&#xD;
        function are limited. At present, the pain diagnosis and treatment guidelines recommend that&#xD;
        non-drug treatment should be used as a first-line treatment measure. Low intensity laser&#xD;
        therapy can alleviate chronic musculoskeletal pain through multiple effects such as&#xD;
        anti-inflammatory, promoting blood circulation, and promoting tissue repair. However, a large&#xD;
        number of high-quality clinical studies are still needed to confirm its effectiveness. In&#xD;
        view of this, this study aims to investigate the safety and effectiveness of dual wavelength&#xD;
        weak laser therapy for chronic musculoskeletal pain independently developed in China, in&#xD;
        order to clarify the clinical application value of this technology.&#xD;
  &#xD;
        Research protocol:&#xD;
  &#xD;
        This study is an intervention study. The participants will be assigned to different treatment&#xD;
        groups (drug therapy group or low intensity laser therapy) to receive corresponding&#xD;
        treatment. At the end of treatment and 1, 2, and 3 months after treatment, the researchers&#xD;
        will evaluate treatment efficacy through a questionnaire survey.&#xD;
  &#xD;
        This study will (1) compare the degree of pain relief, functional improvement, sleep quality,&#xD;
        quality of daily life, and incidence of adverse reactions in patients with chronic&#xD;
        musculoskeletal pain after receiving weak laser therapy and NSAIDs treatment; (2) study the&#xD;
        analgesic effect of low intensity laser therapy on different types of chronic musculoskeletal&#xD;
        pain, and determine the advantageous disease types for this treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 21, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment effectiveness</measure>
      <time_frame>the end of treatment (day21)</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the proportion of patients with a decrease in NRS score of ≥ 30% 1 month after treatment</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the proportion of patients with a decrease in NRS score of ≥ 30% 2 months after treatment</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the proportion of patients with a decrease in NRS score of ≥ 30% 3 months after treatment</measure>
      <time_frame>3 months after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the proportion of patients with a decrease in NRS score of ≥ 50% at the end of treatment</measure>
      <time_frame>the end of treatment (day21)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the proportion of patients with a decrease in NRS score of ≥ 50% 1 month after treatment</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the proportion of patients with a decrease in NRS score of ≥ 50% 2 months after treatment</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the proportion of patients with a decrease in NRS score of ≥ 50% 3 months after treatment</measure>
      <time_frame>3 months after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NRS at the end of treatment (day21)</measure>
      <time_frame>the end of treatment (day21)</time_frame>
      <description>At the end of treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NRS 1 month after treatment</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>1 month after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NRS 2 months after treatment</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>2 months after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NRS 3 months after treatment</measure>
      <time_frame>3 months after treatment</time_frame>
      <description>3 months after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BPI at the end of treatment (day21)</measure>
      <time_frame>the end of treatment (day21)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BPI 1 month after treatment</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BPI 2 months after treatment</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BPI 3 months after treatment</measure>
      <time_frame>3 months after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RMDQ at the end of treatment (day21)</measure>
      <time_frame>the end of treatment (day21)</time_frame>
      <description>At the end of treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RMDQ 1 month after treatment</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>1 month after treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RMDQ 2 months after treatment</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>2 months after treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RMDQ 3 months after treatment</measure>
      <time_frame>3 months after treatment</time_frame>
      <description>3 months after treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PSQI 3 months after treatment</measure>
      <time_frame>3 months after treatment</time_frame>
      <description>3 months after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PSQI 2 months after treatment</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>2 months after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PSQI 1 month after treatment</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>1 month after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PSQI at the end of treatment (day21)</measure>
      <time_frame>the end of treatment (day21)</time_frame>
      <description>At the end of treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D at the end of treatment (day21)</measure>
      <time_frame>the end of treatment (day21)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D 1 month after treatment</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D 2 months after treatment</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D 3 months after treatment</measure>
      <time_frame>3 months after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HADS 3 months after treatment</measure>
      <time_frame>3 months after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HADS 2 months after treatment</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HADS 1 month after treatment</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HADS at the end of treatment (day21)</measure>
      <time_frame>the end of treatment (day21)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adverse reactions</measure>
      <time_frame>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)</time_frame>
      <description>Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse reactions</measure>
      <time_frame>the end of treatment (day21)</time_frame>
      <description>Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse reactions</measure>
      <time_frame>1 month after treatment</time_frame>
      <description>Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse reactions</measure>
      <time_frame>2 months after treatment</time_frame>
      <description>Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage</description>
    </other_outcome>
    <other_outcome>
      <measure>Adverse reactions</measure>
      <time_frame>3 months after treatment</time_frame>
      <description>Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage</description>
    </other_outcome>
    <other_outcome>
      <measure>NRS before treatment</measure>
      <time_frame>before treatment</time_frame>
      <description>Before treatment, pain NRS (0, no pain; 10, worst pain imaginable) is collected.</description>
    </other_outcome>
    <other_outcome>
      <measure>BPI before treatment</measure>
      <time_frame>before treatment</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>RMDQ before treatment</measure>
      <time_frame>before treatment</time_frame>
      <description>Before treatment, RMDQ (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.</description>
    </other_outcome>
    <other_outcome>
      <measure>PSQI before treatment</measure>
      <time_frame>before treatment</time_frame>
      <description>Before treatment, PSQI (Higher score = better sleep quality) is collected.</description>
    </other_outcome>
    <other_outcome>
      <measure>EQ-5D before treatment</measure>
      <time_frame>before treatment</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>HADS before treatment</measure>
      <time_frame>before treatment</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient basic information</measure>
      <time_frame>before treatment</time_frame>
      <description>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</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">860</enrollment>
    <condition>Pain, Chronic</condition>
    <arm_group>
      <arm_group_label>Non-steroidal drug (Celecoxib) group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Weak laser treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Low intensity laser treatment</intervention_name>
      <description>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.</description>
      <arm_group_label>Weak laser treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Non-steroidal drug (Celecoxib) group</intervention_name>
      <description>Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.</description>
      <arm_group_label>Non-steroidal drug (Celecoxib) group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years old;&#xD;
  &#xD;
            2. Chronic musculoskeletal pain (including cervical spondylosis, periarthritis of&#xD;
               shoulder, osteoarthritis, back muscle Fasciitis, lumbar disc herniation) was&#xD;
               diagnosed, and the pain lasted for more than 3 months;&#xD;
  &#xD;
            3. The degree of pain before treatment was mild to moderate (NRS score&lt;7 points);&#xD;
  &#xD;
            4. Can cooperate in completing consultation and scale evaluation;&#xD;
  &#xD;
            5. Sign an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous spinal surgery or severe spinal diseases (such as fractures, tumors,&#xD;
               inflammation, and infectious diseases);&#xD;
  &#xD;
            2. Suffering from serious systemic diseases, including liver and kidney dysfunction,&#xD;
               cardio cerebral, vascular disease, decompensated metabolic syndrome;&#xD;
  &#xD;
            3. Serious skin diseases (skin cancer, erysipelas, severe eczema, severe dermatitis,&#xD;
               severe psoriasis, lupus, Hives);&#xD;
  &#xD;
            4. Suffering from mental disorders, intellectual disabilities, epilepsy and other&#xD;
               diseases;&#xD;
  &#xD;
            5. Moderate to severe depressive state;&#xD;
  &#xD;
            6. Have a history of drug abuse, drug abuse, and alcohol abuse;&#xD;
  &#xD;
            7. Individuals with contraindications to NSAIDs or laser therapy;&#xD;
  &#xD;
            8. Pregnant women;&#xD;
  &#xD;
            9. Recently participated in other clinical studies.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Gao Feng, M.D.</last_name>
      <phone>+86 13971587381</phone>
      <email>fgao@tjh.tjmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gao Feng, M.D.</last_name>
      <phone>+8613971587381</phone>
      <email>fgao@tjh.tjmu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>China Resources &amp; WISCO General Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xie Weidong</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>LinFen People's Hospital</name>
        <address>
          <city>Linfen</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhang Baohui</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Second Hospital of Shanxi Medical University</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yang Jianxin</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanxi Bethune Hospital</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Chen Jianping</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanxi Provincial People's Hospital</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hao Lijun</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chronic musculoskeletal pain</keyword>
    <keyword>Low intensity laser therapy</keyword>
    <keyword>Non-steroidal drugs</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Musculoskeletal Pain</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Celecoxib</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06009900
  org study id: TJ-IRB20230796
  nct id: NCT06009900
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Treatment effectiveness
  time frame: the end of treatment (day21)
  description: 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.
  measure: the proportion of patients with a decrease in NRS score of ≥ 30% 1 month after treatment
  time frame: 1 month after treatment
  description: 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.
  measure: the proportion of patients with a decrease in NRS score of ≥ 30% 2 months after treatment
  time frame: 2 months after treatment
  description: 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.
  measure: the proportion of patients with a decrease in NRS score of ≥ 30% 3 months after treatment
  time frame: 3 months after treatment
  description: 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.
  measure: the proportion of patients with a decrease in NRS score of ≥ 50% at the end of treatment
  time frame: the end of treatment (day21)
  description: 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.
  measure: the proportion of patients with a decrease in NRS score of ≥ 50% 1 month after treatment
  time frame: 1 month after treatment
  description: 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.
  measure: the proportion of patients with a decrease in NRS score of ≥ 50% 2 months after treatment
  time frame: 2 months after treatment
  description: 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.
  measure: the proportion of patients with a decrease in NRS score of ≥ 50% 3 months after treatment
  time frame: 3 months after treatment
  description: 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.
  measure: NRS at the end of treatment (day21)
  time frame: the end of treatment (day21)
  description: At the end of treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.
  measure: NRS 1 month after treatment
  time frame: 1 month after treatment
  description: 1 month after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.
  measure: NRS 2 months after treatment
  time frame: 2 months after treatment
  description: 2 months after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.
  measure: NRS 3 months after treatment
  time frame: 3 months after treatment
  description: 3 months after treatment, Numerical Rating Scale (NRS) (0, no pain; 10, worst pain imaginable) of pain is collected.
  measure: BPI at the end of treatment (day21)
  time frame: the end of treatment (day21)
  description: 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.
  measure: BPI 1 month after treatment
  time frame: 1 month after treatment
  description: 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.
  measure: BPI 2 months after treatment
  time frame: 2 months after treatment
  description: 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.
  measure: BPI 3 months after treatment
  time frame: 3 months after treatment
  description: 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.
  measure: RMDQ at the end of treatment (day21)
  time frame: the end of treatment (day21)
  description: At the end of treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.
  measure: RMDQ 1 month after treatment
  time frame: 1 month after treatment
  description: 1 month after treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.
  measure: RMDQ 2 months after treatment
  time frame: 2 months after treatment
  description: 2 months after treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.
  measure: RMDQ 3 months after treatment
  time frame: 3 months after treatment
  description: 3 months after treatment, Roland Morris Disability Questionnaire (RMDQ) (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.
  measure: PSQI 3 months after treatment
  time frame: 3 months after treatment
  description: 3 months after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.
  measure: PSQI 2 months after treatment
  time frame: 2 months after treatment
  description: 2 months after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.
  measure: PSQI 1 month after treatment
  time frame: 1 month after treatment
  description: 1 month after treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.
  measure: PSQI at the end of treatment (day21)
  time frame: the end of treatment (day21)
  description: At the end of treatment, Pittsburgh Sleep Quality Index (PSQI) (Higher score = better sleep quality) is collected.
  measure: EQ-5D at the end of treatment (day21)
  time frame: the end of treatment (day21)
  description: 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.
  measure: EQ-5D 1 month after treatment
  time frame: 1 month after treatment
  description: 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.
  measure: EQ-5D 2 months after treatment
  time frame: 2 months after treatment
  description: 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.
  measure: EQ-5D 3 months after treatment
  time frame: 3 months after treatment
  description: 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.
  measure: HADS 3 months after treatment
  time frame: 3 months after treatment
  description: 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.
  measure: HADS 2 months after treatment
  time frame: 2 months after treatment
  description: 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.
  measure: HADS 1 month after treatment
  time frame: 1 month after treatment
  description: 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.
  measure: HADS at the end of treatment (day21)
  time frame: the end of treatment (day21)
  description: 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.
  measure: Adverse reactions
  time frame: 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)
  description: Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage
  measure: Adverse reactions
  time frame: the end of treatment (day21)
  description: Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage
  measure: Adverse reactions
  time frame: 1 month after treatment
  description: Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage
  measure: Adverse reactions
  time frame: 2 months after treatment
  description: Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage
  measure: Adverse reactions
  time frame: 3 months after treatment
  description: Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage
  measure: NRS before treatment
  time frame: before treatment
  description: Before treatment, pain NRS (0, no pain; 10, worst pain imaginable) is collected.
  measure: BPI before treatment
  time frame: before treatment
  description: 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.
  measure: RMDQ before treatment
  time frame: before treatment
  description: Before treatment, RMDQ (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.
  measure: PSQI before treatment
  time frame: before treatment
  description: Before treatment, PSQI (Higher score = better sleep quality) is collected.
  measure: EQ-5D before treatment
  time frame: before treatment
  description: 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.
  measure: HADS before treatment
  time frame: before treatment
  description: 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.
  measure: Patient basic information
  time frame: before treatment
  description: 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
  arm group label: Non-steroidal drug (Celecoxib) group
  arm group type: Active Comparator
  description: Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.
  arm group label: Weak laser treatment group
  arm group type: Experimental
  description: 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.
  intervention type: Device
  intervention name: Low intensity laser treatment
  description: 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.
  arm group label: Weak laser treatment group
  intervention type: Drug
  intervention name: Non-steroidal drug (Celecoxib) group
  description: Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.
  arm group label: Non-steroidal drug (Celecoxib) group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Gao Feng, M.D.
  phone: +86 13971587381
  email: fgao@tjh.tjmu.edu.cn
  last name: Gao Feng, M.D.
  phone: +8613971587381
  email: fgao@tjh.tjmu.edu.cn
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Musculoskeletal Pain
  mesh term: Chronic Pain
  mesh term: Celecoxib