Moxibustion for Knee Osteoarthritis

Moxibustion for Knee Osteoarthritis: a Randomized Pilot Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Osteoarthritis
• Intervention / Treatment: Other: Moxibustion treatment plus usual care; Other: Usual care alone 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Daejeon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Korea Institute of Oriental Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: May 4, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (ESTIMATE): May 17, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): May 17, 2011
• Last Update Submitted That Met QC Criteria: May 16, 2011
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: knee osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Respiratory System Agents; Lobeline
• Other Study ID Numbers: KI1002