Clinical trial NCT01354860: Moxibustion for Knee Osteoarthritis
Official title: Moxibustion for Knee Osteoarthritis: a Randomized Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Idiopathic Osteoarthritis
Keywords: knee osteoarthritis
Lead sponsor: Korea Institute of Oriental Medicine
Sponsor class: OTHER_GOV
First posted: 2011-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale
timeFrame: 4 weeks from baseline
Secondary outcomes:
measure: The change from baseline to 4, 8 and 12 weeks in the Short Form Health Survey (SF)-36
timeFrame: at base line, 4 ,8 and 12 weeks later after allocation
measure: The change from baseline to 4, 8 and 12 weeks in the Beck Depression Inventory(BDI)
timeFrame: at base line, 4 ,8 and 12 weeks later after allocation
measure: The change from baseline to 4, 8 and 12 weeks in the Patient global assessment
timeFrame: 4 ,8 and 12 weeks later after allocation
measure: The change from baseline to 4, 8 and 12 weeks in the physical performance test
timeFrame: at a baseline, 4 ,8 and 12 weeks later after allocation
measure: The change from baseline to 4, 8 and 12 weeks in the Numeric Rating Scale (NRS) for pain
timeFrame: at a baseline, 4 ,8 and 12 weeks later after allocation
measure: The change from baseline to 4, 8 and 12 weeks in the Safety measurement
timeFrame: at a baseline, 4 ,8 and 12 weeks later after allocation
measure: The change from baseline to 4, 8 and 12 weeks in the other WOMAC subscale and global score
timeFrame: at base line, 4 ,8 and 12 weeks later after allocation
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon University Hospital
Study officials:
affiliation: Korea Institute of Oriental Medicine
name: Sun Mi Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References: