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Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Moxibustion
Moxa smoke purification device
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Moxa smoke, Moxibustion, Knee osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chengdu University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

moxibustion group

smoke-free moxibustion group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index(WOMAC) score

Secondary Outcome Measures

Change in the WOMAC subscales (pain, stiffness, and function)
Mean change in Visual Analogue Scale for the pain intensity
Change of Patient global assessment score

Full Information

First Posted
May 10, 2016
Last Updated
February 13, 2020
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02772055
Brief Title
Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis
Official Title
A Multicentre, Randomised, Single Blinded, Parallel-group Study of Moxa Smoke Effect in Moxibustion Treating Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Moxa smoke, Moxibustion, Knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
moxibustion group
Arm Type
Experimental
Arm Description
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.
Arm Title
smoke-free moxibustion group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Moxibustion
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moxa smoke purification device
Intervention Description
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 Measure Information:
Title
Change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index(WOMAC) score
Time Frame
4 weeks from baseline
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Change of Patient global assessment score
Time Frame
at 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants meeting the following criteria will be included: aged between 40 and 75 years diagnosed with knee osteoarthritis formulated by the American College of Rheumatology (ACR). the average severity of knee pain not more than 7 points on a visual analogue scale for most days during the past month agree not have the paregoric during the whole treatment phase 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: inflammatory diseases, including rheumatoid arthritis, cancer, traumatic injury that might be related to the current knee pai autoimmune disease, uncontrolled hypertension diabetes mellitus requiring insulin injection life-threatening cardiovascular or neurological events within the past year chronic respiratory disease,a haemorrhagic disorder alcohol or drug addiction an active infectious disease including tuberculosis a significant knee joint deformity knee replacement surgery for the affected knee knee arthroscopy within the past year steroid injection in the knee joints within the past 3 months injections in the knee joints or joint fluid injection within the past 6 months accept acupuncture, moxibustion, cupping, or herbal medicine within the past 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Shuguang, Professor
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31001350
Citation
Luo L, Liao M, Peng JX, Ma Q, Zhou JY, Zhu LL, Wang X, Chen SS, Yin HY, Wu QF, Zhang CS, Lv P, Tang Y, Yu SG. Comparison of the Efficacy between Conventional Moxibustion and Smoke-Free Moxibustion on Knee Osteoarthritis: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2019 Mar 14;2019:1291947. doi: 10.1155/2019/1291947. eCollection 2019.
Results Reference
derived
PubMed Identifier
28438185
Citation
Zhu LL, Zhou JY, Luo L, Wang X, Peng JX, Chen SS, Yin HY, Wu QF, Zhang CS, Lv P, Tang Y, Yu SG. Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial. Trials. 2017 Apr 24;18(1):188. doi: 10.1186/s13063-017-1846-2.
Results Reference
derived

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Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis

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