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Completed

NCT Number: NCT01354860

Moxibustion for Knee Osteoarthritis

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.

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Key information

Conditions

Idiopathic Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Daejeon University Hospital

Daejeon, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moxibustion treatment plus usual care

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.

Other names: Smokeless indirect moxibustion produced by Haitnim Bosung Inc, Korea.

Usual care alone group

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.

Primary outcomes

  1. knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale

    Time frame: 4 weeks from baseline

    The primary outcome is the knee pain measured by WOMAC pain subscale at 4 weeks from baseline.

Secondary outcomes

  1. 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

  2. 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

  3. 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

    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. 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

    Timed-stand test/standing balance test/Six minue walk test

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Korea Institute of Oriental Medicine

Other Gov

Registry information

Official study title

Moxibustion for Knee Osteoarthritis: a Randomized Pilot Clinical Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 17, 2011
Registry last updated
May 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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