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Moxibustion in Osteoarthritis of the Knee

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

real moxibustion

placebo gel

diclofenac sodium gel

sham moxibustion

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, moxibustion, diclofenac sodium gel

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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;

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

real moxibustion plus placebo gel

diclofenac sodium gel plus sham moxibustion

Arm Description

In subjects with osteoarthritis of the knee

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

The change of Patient global assessment score

Full Information

NCT ID

NCT02769572

First Posted

May 10, 2016

Last Updated

February 13, 2020

Sponsor

Chengdu University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02769572

Brief Title

Moxibustion in Osteoarthritis of the Knee

Official Title

The Effectiveness of Moxibustion Treatment for Osteoarthritis of the Knee : a Double-blinded, Double-dummy, Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

June 2019 (Actual)

Study Completion Date

June 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

5. Study Description

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.

Detailed Description

Aim: To evaluate the effectiveness of moxibustion treatment for patients with osteoarthritis of the knee, with respect to relieving pain, improving the dysfunction and improving their quality of life as well. Design: A multicentre, double-blinded, double-dummy, randomized controlled clinical study will be performed in China. Eligible participants will be randomly assigned to moxibustion group (real moxibustion plus placebo gel) and the control group (diclofenac sodium gel plus sham moxibustion) with a 1:1 allocation ratio. Participants in both groups will receive 12 sessions of real/sham moxibustion in 4 weeks at 3 acupoints (ST35, EX-LE4, ST36 ). Either diclofenac sodium gel or placebo gel will be applied 4 g per knee 4 times daily for 4 weeks. 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 primary outcome measure will be the change of the global scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the end of the course. The secondary outcomes include the change of other subscales (pain, stiffness, and function) of WOMAC, Visual Analogue scale (VAS) and Patient Global Assessment (PGA). Safety will be assessed at every visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

Knee osteoarthritis, moxibustion, diclofenac sodium gel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

real moxibustion plus placebo gel

Arm Type

Experimental

Arm Description

In subjects with osteoarthritis of the knee

Arm Title

diclofenac sodium gel plus sham moxibustion

Arm Type

Active Comparator

Arm Description

In subjects with osteoarthritis of the knee

Intervention Type

Other

Intervention Name(s)

real moxibustion

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo gel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

diclofenac sodium gel

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

sham moxibustion

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks from baseline

Secondary Outcome Measure Information:

Title

The changes from baseline to 2, 4, 8,12 weeks 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

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

Time Frame

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

Title

The change of Patient global assessment score

Time Frame

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

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong Tang, Professor

Organizational Affiliation

Chengdu University of Chinese Traditional Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jianying Zhou

Organizational Affiliation

Chengdu University of Chinese Traditional Medicine

Official's Role

Principal Investigator

Facility Information:

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610075

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

28404609

Citation

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.

Results Reference

derived

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Moxibustion in Osteoarthritis of the Knee

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