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Trial record 8 of 774 for:    Tobacco Smoke

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

Tracking Information
First Submitted Date  ICMJE May 10, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
Change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index(WOMAC) score [ Time Frame: 4 weeks from baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • 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 ]
  • 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 ]
  • Change of Patient global assessment score [ Time Frame: at 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis
Official Title  ICMJE A Multicentre, Randomised, Single Blinded, Parallel-group Study of Moxa Smoke Effect in Moxibustion Treating Knee Osteoarthritis
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Moxibustion
  • 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.
    Interventions:
    • Other: Moxibustion
    • Other: Moxa smoke purification device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 12, 2016)
138
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772055
Other Study ID Numbers  ICMJE 2015CB554504-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chengdu University of Traditional Chinese Medicine
Study Sponsor  ICMJE Chengdu University of Traditional Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yu Shuguang, Professor Chengdu University of Traditional Chinese Medicine
PRS Account Chengdu University of Traditional Chinese Medicine
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP