Moxibustion for Knee Osteoarthritis
|ClinicalTrials.gov Identifier: NCT01354860|
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Osteoarthritis||Other: Moxibustion treatment plus usual care Other: Usual care alone group||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Moxibustion for Knee Osteoarthritis: a Randomized Pilot Clinical Trial|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||May 2011|
|Experimental: Moxibustion treatment plus usual care||
Other: Moxibustion treatment plus usual care
Treatment group received moxibustion treatment three times a week for 4 consecutive weeks, totally 12 sessions of treatment in addition to usual care to manage their knee OA.
Moxibustion points include six local acupuncture points on affected knee joint. Up to two additional tender points will be allowed, if necessary. If participants feel knee pain on both knee joints, study practitioners will provide treatment on both knee.
We will use smokeless indirect moxibustion made of wormwood with a diameter of 1.9 centirmeter and a length of 2.1 centimeter in a cylindrical form for this study (Haitnim Bosung Inc, Korea). Free participant-practitioner interaction will be allowed during the treatment session. Expected total time of each treatment session will be 40 - 60 minutes.
Other Name: Smokeless indirect moxibustion produced by Haitnim Bosung Inc, Korea.
|No Intervention: usual care alone||
Other: Usual care alone group
Usual care alone group can receive or use any kind of treatment other than moxibustion treatment provided as study intervention, which includes surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatment. This also applies to the moxibustion treatment group.
Education material of information on knee osteoarthritis and current management option and self-exercise sheet with a yoga-mat to enhance regular exercise will be provided in both groups at baseline.
- knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale [ Time Frame: 4 weeks from baseline ]The primary outcome is the knee pain measured by WOMAC pain subscale at 4 weeks from baseline.
- The change from baseline to 4, 8 and 12 weeks in the Short Form Health Survey (SF)-36 [ Time Frame: at base line, 4 ,8 and 12 weeks later after allocation ]
- The change from baseline to 4, 8 and 12 weeks in the Beck Depression Inventory(BDI) [ Time Frame: at base line, 4 ,8 and 12 weeks later after allocation ]
- The change from baseline to 4, 8 and 12 weeks in the Patient global assessment [ Time Frame: 4 ,8 and 12 weeks later after allocation ]Practitioners and participants will evaluate the improvement of knee joint symptoms after treatment. They can chose one of the following 5 grades: Excellent, Good, Fair, Poor and Aggravation.
- The change from baseline to 4, 8 and 12 weeks in the physical performance test [ Time Frame: at a baseline, 4 ,8 and 12 weeks later after allocation ]Timed-stand test/standing balance test/Six minue walk test
- The change from baseline to 4, 8 and 12 weeks in the Numeric Rating Scale (NRS) for pain [ Time Frame: at a baseline, 4 ,8 and 12 weeks later after allocation ]
- The change from baseline to 4, 8 and 12 weeks in the Safety measurement [ Time Frame: at a baseline, 4 ,8 and 12 weeks later after allocation ]
- The change from baseline to 4, 8 and 12 weeks in the other WOMAC subscale and global score [ Time Frame: at base line, 4 ,8 and 12 weeks later after allocation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354860
|Korea, Republic of|
|Daejeon University Hospital|
|Daejeon, Korea, Republic of|
|Principal Investigator:||Sun Mi Choi, PhD||Korea Institute of Oriental Medicine|