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A study on the efficacy and safety of intramuscular patch based on 'Tendon Softening Bone strengthening' for early KOA prevention

A study on the efficacy and safety of intramuscular patch based on 'Tendon Softening Bone strengthening' for early KOA prevention

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069042
Enrollment
Unknown
Registered
2023-03-06
Start date
2023-03-05
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

KOA

Interventions

Control group:Basic treatment + Diclofenac diethylamine emulsion
Treatment group:Basic treatment + kinesio taping

Sponsors

The First Teaching Hospiital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-60 years (>18.0 years at enrollment and <60.0 years at the end of the outgoing follow-up) 2. patients with early diagnosis of KOA in accordance with the Chinese Medical Association's Guidelines for the Treatment of Osteoarthritis, 2018 edition 3. unilateral knee onset and 3 points = VAS score = 6 points and HSS score = 59 points. 4. informed consent and signed informed consent form. 5. those who can be followed up and can describe the changes in their condition in more detail

Exclusion criteria

Exclusion criteria: 1. Patients with non-KOA knee pain as the main cause, and patients with chronic pain caused by other diseases. 2. Combined with serious diseases of the heart, brain, liver, kidney and hematopoietic system or abnormal liver and kidney function. 3. Patients with history of drug allergy (especially NSAID allergy), or allergic patients (allergic to more than 2 types of substances), or local skin allergy of lower extremities (especially allergic to topical drugs). 4. Pregnant, preparing for pregnancy or breastfeeding women, psychiatric patients, etc. 5. Those who have local skin lesions, infections or other topical drug treatments on the joints. 6. Patients who have participated or are participating in other clinical trials within the last 1 month. 7. Patients who, in the judgment of the investigator, have poor compliance and are unable to complete the experiment, or others who, in the judgment of the investigator, are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
visual analog scale (VAS);Hospital for special surgery (HSS);EMG signal on the surface of the quadriceps muscle;Infrared thermal imaging temperature difference value;

Countries

China

Contacts

Public ContactZHANG Juntao

The First Teaching Hospiital of Tianjin University of TCM

zhangchlon@163.com17749857336

Outcome results

None listed

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