Moxibustion for Knee Osteoarthritis

NCT ID: NCT01354860

Last Updated: 2011-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-05-31

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.

Conditions

Idiopathic Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Moxibustion treatment plus usual care

Group Type: EXPERIMENTAL

Moxibustion treatment plus usual care

Intervention Type: OTHER

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 Type: NO_INTERVENTION

Usual care alone group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Smokeless indirect moxibustion produced by Haitnim Bosung Inc, Korea.

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Korea Institute of Oriental Medicine (KIOM)

Principal Investigators

Sun Mi Choi, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea Institute of Oriental Medicine

Locations

Daejeon University Hospital

Daejeon, , South Korea

Countries

South Korea

Other Identifiers

KI1002

Identifier Type: -

Identifier Source: org_study_id