Moxibustion for Knee Osteoarthritis

Korea Institute of Oriental Medicine

Status and phase: Completed; Phase 2; Phase 1

Conditions: Idiopathic Osteoarthritis

Treatments: Other: Moxibustion treatment plus usual care; Other: Usual care alone group

Study type: Interventional

Funder types: Other

Identifiers

NCT01354860

KI1002

Details and patient eligibility

About

This study aims to assess the feasibility, effectiveness and safety of moxibustion for symptom management and function improvement in patients with knee osteoarthritis, compared to usual care group.

Full description

Knee osteoarthritis (OA) is a common joint disease and a leading cause of pain and physical disability in older people. Its symptoms, including pain and physical disability, significantly affect patient's quality of life, and increased depression has been observed in patients with greater pain due to knee OA. Current management options include exercise, weight reduction, Non-steroidal anti-inflammatory drugs (NSAIDs) and other pain medication, intra-articular injections of steroid or hyaluronan, arthroscopic surgery and joint replacement. Except exercise and weight reduction, no known interventions have shown definitive evidence of benefits and safety for knee OA. Thus, it is still worth exploring effective and safe management options for knee OA patients.

Moxibustion is one of traditional Asian medicine using the heat stimulation by burning mugwort (mainly Artemisia vulgaris or Artemisia argyi) on acupuncture points, and regarded as a subtype of acupuncture. Previous literatures reported its use on chronic conditions including gastrointestinal disease, hypertension, musculoskeletal pain, cancer care, gynecological conditions and stroke rehabilitation solely or in combination with routine care or other traditional medicine. However, studies adequately evaluating effects and safety of moxibustion for patients with knee OA are insufficient. Given the gaps between little evidence for effects and safety of moxibustion for knee osteoarthritis and its wide use in clinical practice, the investigators attempted to assess the feasibility, effectiveness and safety of moxibustion for patients with knee osteoarthritis.

Enrollment: 40 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged from 40 to 70 years old
• Average daily knee pain over 40 points (0-100 point scale)
• diagnosed as knee osteoarthritis according to ACR criteria

Exclusion criteria

• Current of past history of inflammatory disease including rheumatoid arthritis
• Cancer
• Traumatic injury which might be related to current knee pain
• Autoimmune disease
• significant deformity of knee joints
• knee replacement surgery on affected knee
• knee arthroscopy within 2 years
• steroid injection in knee joints within 3 months
• viscosupplement injections in knee joints within 6 months
• joint fluid injection within 6 months
• received acupuncture, moxibustion, cupping or herbal medicine within 4 weeks
• uncontrolled hypertension
• diabetes mellitus requiring insulin injection
• life-threatening cardiovascular or neurological events within one year
• chronic respiratory disease
• hemorrhagic disorder
• alcohol or drug addition
• active infectious disease including tuberculosis
• keloidosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Moxibustion treatment plus usual care

Experimental group

Treatment:

Other: Moxibustion treatment plus usual care

usual care alone

No Intervention group

Treatment:

Other: Usual care alone group