Moxibustion for Knee Osteoarthritis

Phase 1

Completed

• Conditions: Idiopathic Osteoarthritis
• Interventions: Other: Moxibustion treatment plus usual care; Other: Usual care alone group

• Registration Number: NCT01354860
• Lead Sponsor: Korea Institute of Oriental Medicine

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.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-12
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-05-16
• Last Update Submitted: 2011-05-16
• Study First Posted: 2011-05-17
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxibustion treatment plus usual care	Moxibustion treatment plus usual care	-
usual care alone	Usual care alone group	-

Primary Outcome Measures

Name	Time	Method
knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale	4 weeks from baseline	The primary outcome is the knee pain measured by WOMAC pain subscale at 4 weeks from baseline.

Secondary Outcome Measures

Name	Time	Method
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	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	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	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

Trial Locations

Locations (1)

Daejeon University Hospital; 🇰🇷 Daejeon, Korea, Republic of