A pilot Study on the Efficacy and Safety of Thread-Embedding Acupuncture for the Treatment on Knee osteoarthritis patients after total knee arthroplasty

A pilot study of thread-embedding acupuncture on patients with osteoarthritis of the knee received total knee arthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005923

Enrollment

Registered

2021-02-22

Start date

2021-04-01

Completion date

Unknown

Last updated

2021-03-22

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

Conditions

None listed

Interventions

Procedure/Surgery : Thread-embedding therapy (TET) group and sham thread-embedding therapy (STET) group will be treated once a week for 8 weeks, using 29G x 40mm TET on predefined 6 acupoints selected

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female aged between 40 and 80 years. 2. Applicable for 100 mm Pain VAS 30 to 80. 3. Limited knee joint function after 2 or more months after total knee arthroplasty. (A person with a limit of 15% or more of the normal bending function and a range of motion of 90 degrees or more) 4. Those who agree to participate after providing written informed consent. 5. If you are receiving existing treatment, a person who can agree to washout and cooperate.

Exclusion criteria

Exclusion criteria: 1. Knee flexion range of motion is less than 90 degrees. 2. In case of bilateral surgery, both sides are limited in flexion. 3. Patients with systemic diseases such as inflammatory joint disease (eg : RA) or tumor. 4. Patients with hemophilia or post-traumatic OA. 5. Renal and hepatic dysfunction : AST or ALT > 2 times or higher than normal range or BUN, serum creatinine > 2.0 ? / ?. 6. Patients with restrictive disease for use of non-steroidal anti-inflammatory drugs (NSAIDs) or patients hypersensitive or are taking drugs that are contradicted to NSAIDS. 7. Pregnant and lactating women.(Female of childbearing age will go through pregnancy test before the treatment) 8. Patients taking drugs for mental illness that can not follow clinical test compliance. 9. All other joint diseases and orthopedic diseases that are deemed impossible to participate in this clinical trial. 10. Patients who received intraarticular steroid injections in the previous 3 months. 11. Patients who are deemed to unsuitable for experiments.

Design outcomes

Primary

Measure	Time frame
Variation of knee joint range of motion (ROM)	—

Secondary

Measure	Time frame
KWOMAC (Korean Western Ontario and McMaster Universities Osteoarthritis Index);Variation of 100mm pain VAS (visual analogue scale) ;Euroqol - 5 Dimensions - 5Levels;Evaluation of treatment satisfaction ;Cost-benefit analysis	—

Countries

Korea, Republic of

Contacts

Public ContactYeoncheol Park

Kyung Hee University Oriental Medicine Hospital at Gangdong

Outcome results