Moxibustion for Knee Osteoarthritis

Idiopathic Osteoarthritis Clinical Trial

Official title:

Moxibustion for Knee Osteoarthritis: a Randomized Pilot Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354860
• Other study ID #: KI1002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 4, 2011
• Last updated: May 16, 2011
• Start date: December 2010
• Est. completion date: May 2011

Study information

• Verified date: September 2010
• Source: Korea Institute of Oriental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Daejeon University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale	The primary outcome is the knee pain measured by WOMAC pain subscale at 4 weeks from baseline.	4 weeks from baseline	No
Secondary	The change from baseline to 4, 8 and 12 weeks in the Short Form Health Survey (SF)-36		at base line, 4 ,8 and 12 weeks later after allocation	No
Secondary	The change from baseline to 4, 8 and 12 weeks in the Beck Depression Inventory(BDI)		at base line, 4 ,8 and 12 weeks later after allocation	No
Secondary	The change from baseline to 4, 8 and 12 weeks in the Patient global assessment	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.	4 ,8 and 12 weeks later after allocation	No
Secondary	The change from baseline to 4, 8 and 12 weeks in the physical performance test	Timed-stand test/standing balance test/Six minue walk test	at a baseline, 4 ,8 and 12 weeks later after allocation	No
Secondary	The change from baseline to 4, 8 and 12 weeks in the Numeric Rating Scale (NRS) for pain		at a baseline, 4 ,8 and 12 weeks later after allocation	No
Secondary	The change from baseline to 4, 8 and 12 weeks in the Safety measurement		at a baseline, 4 ,8 and 12 weeks later after allocation	Yes
Secondary	The change from baseline to 4, 8 and 12 weeks in the other WOMAC subscale and global score		at base line, 4 ,8 and 12 weeks later after allocation	No