NCT06009900

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
860

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2024

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

August 7, 2023

Last Update Submit

August 20, 2023

Conditions

Pain, Chronic

Keywords

Chronic musculoskeletal painLow intensity laser therapyNon-steroidal drugs

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (31)

  • the proportion of patients with a decrease in NRS score of ≥ 30% 1 month after treatment

    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 proportion of patients with a decrease in NRS score of ≥ 30% 3 months after treatment

    3 months after treatment

  • the proportion of patients with a decrease in NRS score of ≥ 50% at the end of treatment

    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

  • +26 more secondary outcomes

Other Outcomes (12)

  • Adverse reactions

    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

    the end of treatment (day21)

  • Adverse reactions

    1 month after treatment

  • +9 more other outcomes

Study Arms (2)

Non-steroidal drug (Celecoxib) group

ACTIVE COMPARATOR

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

Drug: Non-steroidal drug (Celecoxib) group

Weak laser treatment group

EXPERIMENTAL

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

Interventions

Low intensity laser treatmentDEVICE

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.

Weak laser treatment group
Non-steroidal drug (Celecoxib) groupDRUG

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

Non-steroidal drug (Celecoxib) group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old;
  • 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;
  • The degree of pain before treatment was mild to moderate (NRS score\<7 points);
  • Can cooperate in completing consultation and scale evaluation;
  • Sign an informed consent form.

You may not qualify if:

  • Previous spinal surgery or severe spinal diseases (such as fractures, tumors, inflammation, and infectious diseases);
  • Suffering from serious systemic diseases, including liver and kidney dysfunction, cardio cerebral, vascular disease, decompensated metabolic syndrome;
  • Serious skin diseases (skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis, lupus, Hives);
  • Suffering from mental disorders, intellectual disabilities, epilepsy and other diseases;
  • Moderate to severe depressive state;
  • Have a history of drug abuse, drug abuse, and alcohol abuse;
  • Individuals with contraindications to NSAIDs or laser therapy;
  • Pregnant women;
  • Recently participated in other clinical studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

China Resources & WISCO General Hospital

Wuhan, Hubei, China

Location

LinFen People's Hospital

Linfen, Shanxi, China

Location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

CelecoxibPopulation Groups

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDemographyPopulation Characteristics

Central Study Contacts

Gao Feng, M.D.

CONTACT

+86 13971587381fgao@tjh.tjmu.edu.cn

Gao Feng, M.D.

CONTACT

+8613971587381fgao@tjh.tjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 24, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 21, 2024

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations

CN(5)