NCT02769572

Brief Summary

This is a multicenter , double-blinded, double-dummy, randomized controlled clinical trial to evaluate the efficacy of moxibustion for osteoarthritis of the knee.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P25-P50 for phase_3 knee-osteoarthritis

Timeline
Completed

Started May 2016

Typical duration for phase_3 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

3.1 years

First QC Date

May 10, 2016

Last Update Submit

February 13, 2020

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritismoxibustiondiclofenac sodium gel

Outcome Measures

Primary Outcomes (1)

  • The change of the global scale of the Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    4 weeks from baseline

Secondary Outcomes (3)

  • The changes from baseline to 2, 4, 8,12 weeks in the WOMAC subscales (pain, stiffness, and function)

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

  • The change from baseline to 2, 4, 8,12 weeks in Visual Analogue Scale for the pain intensity.

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

  • The change of Patient global assessment score

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

Study Arms (2)

real moxibustion plus placebo gel

EXPERIMENTAL

In subjects with osteoarthritis of the knee

Other: real moxibustionDrug: placebo gel

diclofenac sodium gel plus sham moxibustion

ACTIVE COMPARATOR

In subjects with osteoarthritis of the knee

Drug: diclofenac sodium gelOther: sham moxibustion

Interventions

real moxibustionOTHER

3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 )

real moxibustion plus placebo gel
placebo gelDRUG

4 grams per knee, 4 times per day, for 4 weeks

real moxibustion plus placebo gel
diclofenac sodium gelDRUG

4 grams per knee, 4 times per day, for 4 weeks

diclofenac sodium gel plus sham moxibustion
sham moxibustionOTHER

3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 )

diclofenac sodium gel plus sham moxibustion

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged between 40 and 75 years, with knee osteoarthritis diagnosed according to American College of Rheumatology criteria
  • Radiologic confirmation of osteoarthritis in 1 or both knees (Kellgren-Lawrence score 2 or 3)
  • Had knee pain in one or both knee(s) of longer than 3 months'duration
  • The average severity of knee pain at least 3 points on a10-point of visual analogue scale(VAS)
  • Never experienced moxibustion before this trial
  • Participants who are willing to comply with our study protocol
  • Participants who agree to sign the consent form

You may not qualify if:

  • Subjects with serious diseases including cancer, uncontrolled hypertension, diabetes mellitus requiring insulin injection, life-threatening cardiovascular or neurological events, chronic respiratory disease, a haemorrhagic disorder and serious mental diseases
  • Subjects had pain in the knee may caused by inflammatory, malignant, autoimmune disease or traumatic injury;
  • Subjects received knee replacement surgery for the affected knee
  • Subjects received knee arthroscopy within the past year, steroid or hyaluronic acid injection in the knee joints within the previous 3 months
  • Subject who currently participate in another clinical trial
  • Subjects received physiotherapy or other treatments for osteoarthritis knee pain (with the exception of non-steroidal anti-inflammatory drugs) during the previous 4 weeks;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Chengdu, Sichuan, 610075, China

Location

Related Publications (1)

  • Zhou JY, Luo L, Zhu LL, Yin HY, Wu Q, Peng JX, Zhang CS, Lv P, Tang Y, Yu SG. Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a study protocol for a double-blinded, double-placebo, randomised controlled trial. BMJ Open. 2017 Apr 12;7(4):e012879. doi: 10.1136/bmjopen-2016-012879.

    PMID: 28404609DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Yong Tang, Professor

    Chengdu University of Chinese Traditional Medicine

    STUDY DIRECTOR

  • Jianying Zhou

    Chengdu University of Chinese Traditional Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 11, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Locations

CN(1)