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Study on the efficacy and safety of Tongluo analgesic cream for chronic musculoskeletal pain (stasis, cold and wet obstruction).

Study on the efficacy and safety of Tongluo analgesic cream for chronic musculoskeletal pain (stasis, cold and wet obstruction).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068897
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic musculoskeletal pain (stasis, cold and wet obstruction)

Interventions

Experimental group:Tongluo analgesic cream intervention
Positive control group:Loxoprofen sodium patch intervention
Placebo control group:Pathway analgesic cream mimicry/loxoprofen sodium patch mimicry intervention

Sponsors

Gansu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for chronic musculoskeletal pain, and the differentiation is stasis stasis, cold and wet obstruction. If it is chronic low back pain, it must meet the diagnostic criteria of the American Physical Therapy Association for chronic low back pain and the course of the disease must be greater than or equal to half a year; (2) local pain as the main complaint, and 4 points<= current pain VAS score of a single site <= 8 points; (3) 18-65 years old, male or female, junior high school education level or above, clear understanding and expression ability; (4) The subject signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Chronic musculoskeletal pain secondary to infectious inflammation, Parkinson's disease, multiple sclerosis or unknown etiology; Patients with fibromyalgia; Patients with variable or frequent pain location; Chronic musculoskeletal pain due to structural changes that meet the indications for surgery; Chronic post-traumatic limb pain and chronic neuropathic limb pain; Patients who have had multiple previous treatment failures due to lack of efficacy or poor tolerability; (2) The onset of pain lasts for more than 3 days; or the pain has been significantly reduced since the onset of this pain; (3) Those who have received analgesics, nonsteroidal anti-inflammatory drugs, misoprostol, antidepressants or quinolone antibacterial agents within 1 week; (4) Consult those with a history of hypertension, heart failure, anemia, bronchial asthma, peptic ulcer, ulcerative colitis, Crohn's disease and so on; (5) Consult those with other serious primary cardiovascular diseases, liver diseases (such as previous history of liver function exceeding the upper limit of normal value), renal lesions (such as previous history of renal function Cr exceeding the upper limit of normal value), hematological lesions, lung diseases, digestive tract lesions or serious diseases affecting their survival; Those with tumors, tuberculosis and other diseases; (6) Those who have broken or abnormal skin (such as rash, eczema, after surgery, etc.) at the application site, allergic skin; (7) Consult women who are breastfeeding, pregnant or preparing for pregnancy within half a year; (8) Those who have a history of drug patch substrate and drug allergy, or allergic constitution (those who are allergic to more than 2 types of substances). Those who have previously induced asthma, urticaria or allergic reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs; (9) Those who have participated in other clinical trials within 3 months of the consultation; (10) Have circumstances that the investigator believes are not suitable for participating in the research, such as the motor state or working state that may aggravate the pain.

Design outcomes

Primary

MeasureTime frame
Visual analogue scoring;ID pain scale;Concise Pain Assessment Scale;Concise McGill Pain Questionnaire;Improved Barthel Index (MBI) score;ODI index;

Countries

China

Contacts

Public ContactDeng Qiang

Gansu Provincial Hospital of Traditional Chinese Medicine

1031518835@qq.com+86 150 0259 1575

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026