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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Drug: Non-steroidal drug (Celecoxib) group; Device: Low intensity laser treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 860
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gao Feng, M.D.; Phone Number: +86 13971587381; Email: fgao@tjh.tjmu.edu.cn
• Study Contact Backup: Name: Gao Feng, M.D.; Phone Number: +8613971587381; Email: fgao@tjh.tjmu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • China Resources & WISCO General Hospital
      • Contact: Xie Weidong
  • Shanxi
    • Linfen, Shanxi, China
      • Linfen People's Hospital
      • Contact: Zhang Baohui
    • Taiyuan, Shanxi, China
      • Shanxi Bethune Hospital
      • Contact: Chen Jianping
    • Taiyuan, Shanxi, China
      • Shanxi Provincial People's Hospital
      • Contact: Hao Lijun
    • Taiyuan, Shanxi, China
      • Second Hospital of Shanxi Medical University
      • Contact: Yang Jianxin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-steroidal drug (Celecoxib) group; Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.	Drug: Non-steroidal drug (Celecoxib) group; Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.
Experimental: Weak laser treatment group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
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)
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
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
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
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
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
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
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)
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)
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
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
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
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
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
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
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Adverse reactions	Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage	the end of treatment (day21)
Adverse reactions	Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage	1 month after treatment
Adverse reactions	Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage	2 months after treatment
Adverse reactions	Adverse reactions, such as non-steroidal drugs-associated adverse reaction, weak laser-related skin damage	3 months after treatment
NRS before treatment	Before treatment, pain NRS (0, no pain; 10, worst pain imaginable) is collected.	before treatment
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
RMDQ before treatment	Before treatment, RMDQ (Scores 0 to 24, higher score, indicates greater activity limitation) is collected.	before treatment
PSQI before treatment	Before treatment, PSQI (Higher score = better sleep quality) is collected.	before treatment
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
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
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

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Second Hospital of Shanxi Medical University; Shanxi Provincial People's Hospital; Shanxi Bethune Hospital; China Resources WISCO General Hospital; LinFen People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): December 21, 2024

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 20, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Chronic musculoskeletal pain; Low intensity laser therapy; Non-steroidal drugs
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Chronic Pain; Musculoskeletal Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: TJ-IRB20230796

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No