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Clinical study on using the MEMS micro-needle to Promote penetration and Layers adjusting extemal application technique for treating end-stage knee osteoarthritis,based on the theory of pain as pivot and truncating and reversing

Clinical study on using the MEMS micro-needle to Promote penetration and Layers adjusting extemal application technique for treating end-stage knee osteoarthritis,based on the theory of pain as pivot and truncating and reversing

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013361
Enrollment
Unknown
Registered
2017-11-13
Start date
2017-11-15
Completion date
Unknown
Last updated
2017-11-20

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

Conditions

Knee osteoarthritis

Interventions

The treatment group:The MEMS micro-needle to Promote penetration and Layers adjusting extemal application technique
The control group:Diclofenac diethylamine emulsion

Sponsors

Jiangsu Province Hospital Of TCM
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the western medicine diagnostic criteria for knee osteoarthritis,and meet the following conditions: (1) Radiological disease classification in grade III-IV; (2) Joint functional classification in grade III-IV; (3) The WOMAC total is between 80 and 120; 2. Aged greater than or equal to 40 years; 3. After 7 days washout period, if the patients with chronic knee osteoarthritis have received other nonsurgical treatments; 4. Informed consent. ;Inclusion criteria: 1. Meet the western medicine diagnostic criteria for knee osteoarthritis,and meet the following conditions: (1) Radiological disease classification in grade III-IV; (2) Joint functional classification in grade III-IV; (3) The WOMAC total is between 80 and 120; 2. Aged greater than or equal to 40 years; 3. After 7 days washout period, if the patients with chronic knee osteoarthritis have received other nonsurgical treatments; 4. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Knee osteoarthritis associated with acute synovitis; 2. Knee joint tuberculosis, tumour, rheumatoid arthritis; 3. Complications affecting the joints, such as psoriasis, syphilitic mental derangement, ochronosis, metabolic bone disease, acute trauma and so on; 4. Nearly 60 days took the systemic or joint cavity hormone therapy; Nearly 3 months, evaluated the knee joint with cavities injection or arthroscopy; 5. The skin of wound was damaged, or other diseases affected treating with the local administration of wound, such as skin diseases and so on; 6. Allergy sufferers; 7. Women during the lactation, pregnancy or planning a pregnancy; 8. Patients who are participating in other drug clinical trials; 9. In addition to the OA, Taking painkillers for other chronic or recurrent pain; 10. According to the researchers' judgment, there are other lesions or conditions that reduce the possibility of entering the group or complicating the group, such as frequent changes in the working environment, etc.;Exclusion criteria: 1. Knee osteoarthritis associated with acute synovitis; 2. Knee joint tuberculosis, tumour, rheumatoid arthritis; 3. Complications affecting the joints, such as psoriasis, syphilitic mental derangement, ochronosis, metabolic bone disease, acute trauma and so on; 4. Nearly 60 days took the systemic or joint cavity hormone therapy; Nearly 3 months, evaluated the knee joint with cavities injection or arthroscopy; 5. The skin of wound was damaged, or other diseases affected treating with the local administration of wound, such as skin diseases and so on; 6. Allergy sufferers; 7. Women during the lactation, pregnancy or planning a pregnancy; 8. Patients who are participating in other drug clinical trials; 9. In addition to the OA, Taking painkillers for other chronic or recurrent pain; 10. According to the researchers' judgment, there are other lesions or conditions that reduce the possibility of entering the group or complicating the group, such as frequent changes in the working environment, etc.

Design outcomes

Primary

MeasureTime frame
WOMAC;Joint functional classification;;WOMAC;Joint functional classification;

Secondary

MeasureTime frame
X-ray classification;MRI classification;Routine blood;CRP;blood lipids;Liver and kidney function;MMPs;OPG;RANKL;TIMP-1;IL-6;TNF-a;;X-ray classification;MRI classification;Routine blood;CRP;blood lipids;Liver and kidney function;MMPs;OPG;RANKL;TIMP-1;IL-6;TNF-a;

Countries

China

Contacts

Public ContactPeimin Wang;Peimin Wang ;

Jiangsu Province Hospital of TCM ;Jiangsu Province Hospital of TCM

drwpm@163.com;drwpm@163.com+86 13921438618;+86 13921438618

Outcome results

None listed

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