Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis

NCT02772055 | Completed

• 1 other identifier: 2015CB554504-02
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Moxa smoke; Moxibustion; Knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

  4 weeks from baseline

Secondary Outcomes (3)

• Change in the WOMAC subscales (pain, stiffness, and function)

  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

  Assessing participants at baseline(0 week), 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation

• Change of Patient global assessment score

  at 2 weeks, 4weeks, 8 weeks and 12 weeks later after allocation

Study Arms (2)

moxibustion group

EXPERIMENTAL

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

smoke-free moxibustion group

EXPERIMENTAL

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; Other: Moxa smoke purification device

Interventions

Moxibustion OTHER

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.

moxibustion group; smoke-free moxibustion group

Moxa smoke purification device OTHER

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.

smoke-free moxibustion group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

Related Publications (2)

• 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.

  PMID: 31001350 DERIVED

• 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.

  PMID: 28438185 DERIVED

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Study Officials

• Yu Shuguang, Professor

  Chengdu University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 13, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)