Pain, ChronicNCT06009900
Safety and Efficacy of Low-intensity Laser Therapy in the Treatment of Chronic Musculoskeletal Pain
A study testing Low intensity laser treatment and Non-steroidal drug (Celecoxib) group in people with Pain, Chronic, run by Tongji Hospital at 5 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Low intensity laser treatment and Non-steroidal drug (Celecoxib) group
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 5 sitesChina
- Study dates
- 1 Sep 2023to 21 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- Individuals with contraindications to NSAIDs or laser therapy;
- Pregnant women;
- Recently participated in other clinical studies.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
LinFen People's Hospital
Linfen, Shanxi
Zhang Baohui
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Yang Jianxin
Shanxi Bethune Hospital
Taiyuan, Shanxi
Chen Jianping
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
Hao Lijun
China Resources & WISCO General Hospital
Wuhan, Hubei
Xie Weidong
About this study
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.
Read the 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
- Being tested
- Low intensity laser treatment, Non-steroidal drug (Celecoxib) group
- Keywords
- Chronic musculoskeletal pain, Low intensity laser therapy, Non-steroidal drugs
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Non-steroidal drug (Celecoxib) groupDrug
Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Non-steroidal drug (Celecoxib) group | Active comparator | Oral Celecoxib 200mg/time, twice a day, for three consecutive weeks. Receives: 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. Receives: Device: Low intensity laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: the end of treatment (day21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion21 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Bethune Hospital, Second Hospital of Shanxi Medical University, Shanxi Provincial People's Hospital, China Resources WISCO General Hospital, Linfen No.4 People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009900
- Sponsor's protocol ID
- TJ-IRB20230796
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low-intensity Laser Therapy in the Treatment of Chronic Musculoskeletal Pain: a Multicenter Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT06009900
- Acronym / sponsor ID
- TJ-IRB20230796
- Conditions
- Pain, Chronic
- Keywords
- Chronic musculoskeletal pain, Low intensity laser therapy, Non-steroidal drugs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Shanxi Bethune Hospital, Second Hospital of Shanxi Medical University, Shanxi Provincial People's Hospital, China Resources WISCO General Hospital, Linfen No.4 People's Hospital
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 21 Dec 2024 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-steroidal drug (Celecoxib) group | Active comparator | Drug: Non-steroidal drug (Celecoxib) groupOral Celecoxib 200mg/time, twice a day, for three consecutive weeks. |
| Weak laser treatment group | Experimental | Device: Low intensity laser treatmentLow 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity laser treatmentLow 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 | Weak laser treatment group |
| Non-steroidal drug (Celecoxib) groupOral Celecoxib 200mg/time, twice a day, for three consecutive weeks. | Drug | Non-steroidal drug (Celecoxib) group |
Primary outcome
Treatment effectiveness
Time frame: the end of treatment (day21)
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.
31 secondary outcomes
the proportion of patients with a decrease in NRS score of ≥ 30% 1 month after treatment
Time frame: 1 month after treatment
the proportion of patients with a decrease in NRS score of ≥ 30% 2 months after treatment
Time frame: 2 months after treatment
the proportion of patients with a decrease in NRS score of ≥ 30% 3 months after treatment
Time frame: 3 months after treatment
the proportion of patients with a decrease in NRS score of ≥ 50% at the end of treatment
Time frame: the end of treatment (day21)
the proportion of patients with a decrease in NRS score of ≥ 50% 1 month after treatment
Time frame: 1 month after treatment
the proportion of patients with a decrease in NRS score of ≥ 50% 2 months after treatment
Time frame: 2 months after treatment
the proportion of patients with a decrease in NRS score of ≥ 50% 3 months after treatment
Time frame: 3 months after treatment
NRS at the end of treatment (day21)
Time frame: the end of treatment (day21)
NRS 1 month after treatment
Time frame: 1 month after treatment
NRS 2 months after treatment
Time frame: 2 months after treatment
NRS 3 months after treatment
Time frame: 3 months after treatment
BPI at the end of treatment (day21)
Time frame: the end of treatment (day21)
BPI 1 month after treatment
Time frame: 1 month after treatment
BPI 2 months after treatment
Time frame: 2 months after treatment
BPI 3 months after treatment
Time frame: 3 months after treatment
RMDQ at the end of treatment (day21)
Time frame: the end of treatment (day21)
RMDQ 1 month after treatment
Time frame: 1 month after treatment
RMDQ 2 months after treatment
Time frame: 2 months after treatment
RMDQ 3 months after treatment
Time frame: 3 months after treatment
PSQI 3 months after treatment
Time frame: 3 months after treatment
PSQI 2 months after treatment
Time frame: 2 months after treatment
PSQI 1 month after treatment
Time frame: 1 month after treatment
PSQI at the end of treatment (day21)
Time frame: the end of treatment (day21)
EQ-5D at the end of treatment (day21)
Time frame: the end of treatment (day21)
EQ-5D 1 month after treatment
Time frame: 1 month after treatment
EQ-5D 2 months after treatment
Time frame: 2 months after treatment
EQ-5D 3 months after treatment
Time frame: 3 months after treatment
HADS 3 months after treatment
Time frame: 3 months after treatment
HADS 2 months after treatment
Time frame: 2 months after treatment
HADS 1 month after treatment
Time frame: 1 month after treatment
HADS at the end of treatment (day21)
Time frame: the end of treatment (day21)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity laser treatment and Non-steroidal drug (Celecoxib) group in people with Pain, Chronic, run by Tongji Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gao Feng, M.D. (+86 13971587381, fgao@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effectiveness (time frame: the end of treatment (day21)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.