Idiopathic OsteoarthritisPhase 1/2NCT01354860
Moxibustion for Knee Osteoarthritis
A Phase 1/2 study of Idiopathic Osteoarthritis, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Idiopathic Osteoarthritis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to May 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Osteoarthritis
- Being tested
- Moxibustion treatment plus usual care, Usual care alone group
- Keywords
- knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxibustion treatment plus usual careOther
Also called Smokeless indirect moxibustion produced by Haitnim Bosung Inc, Korea.
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.
Usual care alone groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion treatment plus usual care | Experimental | Not described Receives: Other: Moxibustion treatment plus usual care |
| usual care alone | No intervention | Not described Receives: Other: Usual care alone group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks from baseline
Secondary outcomes (7)
The change from baseline to 4, 8 and 12 weeks in the Short Form Health Survey (SF)-36
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at base line, 4 ,8 and 12 weeks later after allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Institute of Oriental Medicine
- Sponsor type
- Other government
- Investigators
- Sun Mi Choi, PhD, Principal investigator, Korea Institute of Oriental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354860
- Sponsor's protocol ID
- KI1002
- Status last verified
- Sep 2010
- First submitted
- 4 May 2011
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moxibustion for Knee Osteoarthritis: a Randomized Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT01354860
- Acronym / sponsor ID
- KI1002
- Conditions
- Idiopathic Osteoarthritis
- Keywords
- knee osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Korea Institute of Oriental MedicineOther government
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxibustion treatment plus usual care | Experimental | Other: Moxibustion treatment plus usual care |
| usual care alone | No intervention | Other: Usual care alone group |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxibustion treatment plus usual careAlso: Smokeless indirect moxibustion produced by Haitnim Bosung Inc, Korea.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 | Moxibustion treatment plus usual care |
| Usual care alone groupUsual 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. | Other | usual care alone |
Primary outcome
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.
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Mi Choi, PhD principal investigator
Korea Institute of Oriental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Idiopathic Osteoarthritis, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee pain measured by Western Ontario MacMaster (WOMAC) pain subscale (time frame: 4 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.