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Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02772055
Recruitment Status : Unknown
Verified May 2016 by Chengdu University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine

Brief Summary:
This is a multicentre, randomised, single blinded, parallel-group design clinical trial to assess the effect of moxa smoke in the treatment using moxibustion for Knee Osteoarthritis.

Condition or disease Intervention/treatment Phase
Pain Other: Moxibustion Other: Moxa smoke purification device Phase 2 Phase 3

Detailed Description:

Aim: To assess the effect of moxa smoke in the treatment using moxibustion for knee osteoarthritis.

Design: This is a multicentre, randomised, single blinded, parallel-group design clinical trial. 138 eligible participants will be randomly allocated into 2 groups (moxibustion group or smoke-free moxibustion group) with a 1:1 allocation ratio, and receive 12 sessions of moxibustion treatment over a period of 4 weeks, three sessions per week. Each session will last 30 minutes. The whole study period is 13 weeks, with a 1 week run in period, 4 week treatment phase, and 8 week follow-up phase.The participants will receive moxibustion treatment at three acupoints (EX-LE04,ST35,ST36). In moxa-free smoke moxibustion group, investigators place a purification device(Shenzhen Conyson Electronic Technology Co, Ltd,C200 moxa smoke purification device,Shenzhen,China) at the top of the moxibustion to remove the moxa smoke. The primary measurement outcomes are the mean change in the global scale value of the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) pain and function scores from baseline to 4 weeks. The secondary outcomes are the Visual Analogue Scale (VAS) and the patient global assessment. Investigators will assess participants at the second visit (before starting moxibustion treatment) and at the 2, 4, 8, and 12 week respectively after the baseline.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Single Blinded, Parallel-group Study of Moxa Smoke Effect in Moxibustion Treating Knee Osteoarthritis
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: moxibustion group
Conventional moxibustion treatment for knee osteoarthritis participants.12 sessions of moxibustion treatment over a period of 4 weeks, 3 sessions per week.Each session will last 30 minutes.
Other: Moxibustion
Moxibustion at three acupuncture point(EX-LE04,ST35,ST36).12 sessions of moxibustion treatment over a period of 4 weeks, 3 sessions per week.Each session will last 30 minutes.

Experimental: smoke-free moxibustion group
Conventional moxibustion treatment for knee osteoarthritis participants and have a purification device at the top of the moxibustion to remove the moxa smoke.12 sessions of moxibustion treatment over a period of 4 weeks, 3 sessions per week.Each session will last 30 minutes.
Other: Moxibustion
Moxibustion at three acupuncture point(EX-LE04,ST35,ST36).12 sessions of moxibustion treatment over a period of 4 weeks, 3 sessions per week.Each session will last 30 minutes.

Other: Moxa smoke purification device
Investigators place a purification device(Shenzhen Conyson Electronic Technology Co, Ltd,C200 moxa smoke purification device,Shenzhen,China) at the top of the moxibustion to remove the moxa smoke.




Primary Outcome Measures :
  1. Change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index(WOMAC) score [ Time Frame: 4 weeks from baseline ]

Secondary Outcome Measures :
  1. Change in the WOMAC subscales (pain, stiffness, and function) [ Time Frame: at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation ]
  2. Mean change in Visual Analogue Scale for the pain intensity [ Time Frame: Assessing participants at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation ]
  3. Change of Patient global assessment score [ Time Frame: at 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants meeting the following criteria will be included:

  1. aged between 40 and 75 years
  2. diagnosed with knee osteoarthritis formulated by the American College of Rheumatology (ACR).
  3. the average severity of knee pain not more than 7 points on a visual analogue scale for most days during the past month
  4. agree not have the paregoric during the whole treatment phase
  5. willingness to participate in a randomized study and to sign the informed consent form.

Exclusion Criteria:

Participants will be excluded if they have these experiences:

  1. inflammatory diseases, including rheumatoid arthritis, cancer, traumatic injury that might be related to the current knee pai
  2. autoimmune disease, uncontrolled hypertension
  3. diabetes mellitus requiring insulin injection
  4. life-threatening cardiovascular or neurological events within the past year
  5. chronic respiratory disease,a haemorrhagic disorder
  6. alcohol or drug addiction
  7. an active infectious disease including tuberculosis
  8. a significant knee joint deformity
  9. knee replacement surgery for the affected knee
  10. knee arthroscopy within the past year
  11. steroid injection in the knee joints within the past 3 months
  12. injections in the knee joints or joint fluid injection within the past 6 months
  13. accept acupuncture, moxibustion, cupping, or herbal medicine within the past 4 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772055


Contacts
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Contact: Tang Yong, Professor 0086-13547888395 tangyong@cdutcm.edu.cn

Locations
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China, Sichuan
Chengdu University of Traditional Chinese Medicine Recruiting
Chengdu, Sichuan, China, 610075
Contact: Yong Tang, professor    0086-13547888395    tangyong@cdutcm.edu.cn   
Contact: Linlin Zhu, MMSC    15281088974    cdzhulinlin@163.com   
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Yu Shuguang, Professor Chengdu University of Traditional Chinese Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02772055     History of Changes
Other Study ID Numbers: 2015CB554504-02
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chengdu University of Traditional Chinese Medicine:
Moxa smoke
Moxibustion
Knee osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases