Moxibustion for Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT01354860
First received: May 4, 2011
Last updated: May 16, 2011
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Idiopathic Osteoarthritis
Other: Moxibustion treatment plus usual care
Other: Usual care alone group
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Moxibustion for Knee Osteoarthritis: a Randomized Pilot Clinical Trial

Resource links provided by NLM:


Further study details as provided by Korea Institute of Oriental Medicine:

Primary Outcome Measures:
  • knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale [ Time Frame: 4 weeks from baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: at base line, 4 ,8 and 12 weeks later after allocation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The change from baseline to 4, 8 and 12 weeks in the Patient global assessment [ Time Frame: 4 ,8 and 12 weeks later after allocation ] [ Designated as safety issue: No ]
    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 [ Time Frame: at a baseline, 4 ,8 and 12 weeks later after allocation ] [ Designated as safety issue: No ]
    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 [ Time Frame: at a baseline, 4 ,8 and 12 weeks later after allocation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.


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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354860

Locations
Korea, Republic of
Daejeon University Hospital
Daejeon, Korea, Republic of
Sponsors and Collaborators
Korea Institute of Oriental Medicine
Investigators
Principal Investigator: Sun Mi Choi, PhD Korea Institute of Oriental Medicine
  More Information

No publications provided

Responsible Party: Kim, Ki-ok/ President of KIOM, Korea Institute of Oriental Medicine (KIOM)
ClinicalTrials.gov Identifier: NCT01354860     History of Changes
Other Study ID Numbers: KI1002
Study First Received: May 4, 2011
Last Updated: May 16, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea Institute of Oriental Medicine:
knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014