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Moxibustion for Knee Osteoarthritis

Primary Purpose

Idiopathic Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Moxibustion treatment plus usual care
Usual care alone group
Sponsored by
Korea Institute of Oriental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Osteoarthritis focused on measuring knee osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daejeon University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Moxibustion treatment plus usual care

usual care alone

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The change from baseline to 4, 8 and 12 weeks in the Short Form Health Survey (SF)-36
The change from baseline to 4, 8 and 12 weeks in the Beck Depression Inventory(BDI)
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.
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
The change from baseline to 4, 8 and 12 weeks in the Numeric Rating Scale (NRS) for pain
The change from baseline to 4, 8 and 12 weeks in the Safety measurement
The change from baseline to 4, 8 and 12 weeks in the other WOMAC subscale and global score

Full Information

First Posted
May 4, 2011
Last Updated
May 16, 2011
Sponsor
Korea Institute of Oriental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01354860
Brief Title
Moxibustion for Knee Osteoarthritis
Official Title
Moxibustion for Knee Osteoarthritis: a Randomized Pilot Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea Institute of Oriental Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Osteoarthritis
Keywords
knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moxibustion treatment plus usual care
Arm Type
Experimental
Arm Title
usual care alone
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Moxibustion treatment plus usual care
Other Intervention Name(s)
Smokeless indirect moxibustion produced by Haitnim Bosung Inc, Korea.
Intervention Description
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
Intervention Name(s)
Usual care alone group
Intervention Description
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.
Primary Outcome Measure Information:
Title
knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale
Description
The primary outcome is the knee pain measured by WOMAC pain subscale at 4 weeks from baseline.
Time Frame
4 weeks from baseline
Secondary Outcome Measure Information:
Title
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
Title
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
Title
The change from baseline to 4, 8 and 12 weeks in the Patient global assessment
Description
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.
Time Frame
4 ,8 and 12 weeks later after allocation
Title
The change from baseline to 4, 8 and 12 weeks in the physical performance test
Description
Timed-stand test/standing balance test/Six minue walk test
Time Frame
at a baseline, 4 ,8 and 12 weeks later after allocation
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Mi Choi, PhD
Organizational Affiliation
Korea Institute of Oriental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daejeon University Hospital
City
Daejeon
Country
Korea, Republic of

12. IPD Sharing Statement

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Moxibustion for Knee Osteoarthritis

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