Safety and Efficacy of Low-intensity Laser Therapy in the Treatment of Chronic Musculoskeletal Pain

NCT ID: NCT06009900

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 860 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-12-21

Brief Summary

This study is a multicenter, prospective, randomized, controlled research design. This study takes classic NSAIDs treatment as a control, and it will take patients' pain relief, functional improvement, sleep quality improvement, and adverse reactions as the main and secondary evaluation indicators to explore the safety and effectiveness of weak laser treatment of chronic musculoskeletal pain, determining the dominant disease in the treatment of Chronic pain.

Detailed Description

Research purpose:

Chronic musculoskeletal pain is the most common clinical Chronic pain. Non-steroidal drugs are the most commonly used therapeutic drugs, but their effects on improving the body function are limited. At present, the pain diagnosis and treatment guidelines recommend that non-drug treatment should be used as a first-line treatment measure. Low intensity laser therapy can alleviate chronic musculoskeletal pain through multiple effects such as anti-inflammatory, promoting blood circulation, and promoting tissue repair. However, a large number of high-quality clinical studies are still needed to confirm its effectiveness. In view of this, this study aims to investigate the safety and effectiveness of dual wavelength weak laser therapy for chronic musculoskeletal pain independently developed in China, in order to clarify the clinical application value of this technology.

Research protocol:

This study is an intervention study. The participants will be assigned to different treatment groups (drug therapy group or low intensity laser therapy) to receive corresponding treatment. At the end of treatment and 1, 2, and 3 months after treatment, the researchers will evaluate treatment efficacy through a questionnaire survey.

This study will (1) compare the degree of pain relief, functional improvement, sleep quality, quality of daily life, and incidence of adverse reactions in patients with chronic musculoskeletal pain after receiving weak laser therapy and NSAIDs treatment; (2) study the analgesic effect of low intensity laser therapy on different types of chronic musculoskeletal pain, and determine the advantageous disease types for this treatment.

Conditions

Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Non-steroidal drug (Celecoxib) group

Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.

Group Type: ACTIVE_COMPARATOR

Non-steroidal drug (Celecoxib) group

Intervention Type: DRUG

Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.

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.

Group Type: EXPERIMENTAL

Low intensity laser treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Non-steroidal drug (Celecoxib) group

Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old;

2. Chronic musculoskeletal pain (including cervical spondylosis, periarthritis of shoulder, osteoarthritis, back muscle Fasciitis, lumbar disc herniation) was diagnosed, and the pain lasted for more than 3 months;

3. The degree of pain before treatment was mild to moderate (NRS score<7 points);

4. Can cooperate in completing consultation and scale evaluation;

5. Sign an informed consent form.

Exclusion Criteria

1. Previous spinal surgery or severe spinal diseases (such as fractures, tumors, inflammation, and infectious diseases);

2. Suffering from serious systemic diseases, including liver and kidney dysfunction, cardio cerebral, vascular disease, decompensated metabolic syndrome;

3. Serious skin diseases (skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis, lupus, Hives);

4. Suffering from mental disorders, intellectual disabilities, epilepsy and other diseases;

5. Moderate to severe depressive state;

6. Have a history of drug abuse, drug abuse, and alcohol abuse;

7. Individuals with contraindications to NSAIDs or laser therapy;

8. Pregnant women;

9. Recently participated in other clinical studies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanxi Bethune Hospital

OTHER

Sponsor Role: collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role: collaborator

Shanxi Provincial People's Hospital

OTHER_GOV

Sponsor Role: collaborator

China Resources WISCO General Hospital

UNKNOWN

Sponsor Role: collaborator

LinFen People's Hospital

UNKNOWN

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Countries

China

Central Contacts

Gao Feng, M.D.

Role: CONTACT

fgao@tjh.tjmu.edu.cn

+86 13971587381

Gao Feng, M.D.

Role: CONTACT

fgao@tjh.tjmu.edu.cn

+8613971587381

Facility Contacts

Xie Weidong

Role: primary

Zhang Baohui

Role: primary

Yang Jianxin

Role: primary

Chen Jianping

Role: primary

Hao Lijun

Role: primary

Other Identifiers

TJ-IRB20230796

Identifier Type: -

Identifier Source: org_study_id