Skip to content

Effectiveness and safety of the infrared ceramic graphene moxibustion device for knee osteoarthritis: study protocol for a Zelen-design randomized controlled non-inferiority clinical trial

Development of intelligent moxibustion physiotherapy rehabilitation equipment based on infrared ceramics/graphene

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006735
Enrollment
Unknown
Registered
2022-11-01
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Knee Osteoarthritis

Interventions

Infrared laser moxibustion (ILM) group:Infrared laser moxibustion device treatment
Traditional moxibustion (TM) group:Traditional moxibustion treatment

Sponsors

Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Diagnosed with KOA according to the American College of Rheumatology criteria(ACR) (2) Aged 40-70 years (3) Average pain score of 4 or more out of 10 on a numeric rating scale (4) average severity score of 48 or less on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (5) Standard radiographs Kellgren and Lawrence (K&L) grade II or III (6) Written informed consent Participants who concomitant meet the above 6 items can be included in the trial.

Exclusion criteria

Exclusion criteria: (1) Received knee surgery in the past 6 months or waiting for surgery (2) Received acupuncture treatment for KOA in the past 3 months (3) Received intra-articular injection for KOA in the past 6 months (4) Received arthroscopy for KOA in the past year (5) Had other diseases, infections or traumatic injuries that can cause knee pain (6) Severe Hypotensive Spinal Anesthesia: Respiratory, Metabolic, Hepatic, Renal and Cerebral Effects. Any one of the above items shall be excluded.

Design outcomes

Primary

MeasureTime frame
the Numeric Rating Scale for Pain (NRS Pain);

Secondary

MeasureTime frame
6-min walking test (6MWT);Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC);knee circumference;SF-36;

Countries

China

Contacts

Public ContactLi Han

Beijing University of Traditional Chinese Medicine

lismit@163.com13811732990

Outcome results

None listed

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