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Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Acupuncture treatment

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patients who have knee OA diagnosed according to the American College of Rheumatology classification criteria (with at least one osteophyte in the tibiofemoral joint and with a Kellgren-Lawrence grade of more than 2).
Male and female patients who have had a history of moderate or greater knee pain of more than 3 months' duration and have reported moderate or greater, clinically significant, knee pain during most days of the last month before the interview.
Male and female patients who have given their consent to participate in the study.
Patients will be selected among those who are not on the waiting list for total knee arthroplasty by the traumatology unit of our hospital.

Exclusion Criteria:

Patients with any of the following will be excluded from the study: a history of any secondary OA associated with any systemic arthropathy (i.e., rheumatoid arthritis or gouty arthritis);
Any knee treatment with steroids, methotrexate, or azathioprine; recent traumatisms caused by acupunctured insertion;
A history of bleeding disorders or any disease related to acupuncture contraindications;
A history of any knee injection in the previous 6 months (e.g., cortisone and hyaluronic acid); a history of morphine or morphine derivative use.

Sites / Locations

Longhua Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Shanghai Longhua hospital

Shanghai Guanghua hospital

Huadong hospital of Fudan University

Shanghai Yueyang Integrated hospital

Arm Description

Acupuncture treatments will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

Outcomes

Primary Outcome Measures

Visual analogue scale

Visual analogue scale assessed for 12 weeks

Secondary Outcome Measures

Western Ontario and McMaster university of orthopedic index

Western Ontario and McMaster university of orthopedic index assessed for 12 weeks.

Lequesne index

Lequesne index assessed for 12 weeks.

Adverse Event

Adverse Event assessed for 12 weeks.

The Medical Outcomes Study short form health survey-36

The Medical Outcomes Study short form health survey-36 assessed for 12 weeks.

Full Information

NCT ID

NCT02948218

First Posted

October 16, 2016

Last Updated

October 26, 2016

Sponsor

Shanghai University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02948218

Brief Title

Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Official Title

Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability. A recent analysis of data indicated that about 35% of women and men aged 60 years and above had radiographic knee OA.Despite the high prevalence rate of OA, the treatment of OA is far from satisfactory. Acupuncture may be a promising treatment option for knee OA due to the effectiveness of the pain relief and the rarity of adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness on KOA, a long-term follow up interventional study will be started to confirm the effects of long term for acupuncture treatment.

Detailed Description

Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability. A recent analysis of data from the National Health and Nutrition Examination Survey III indicated that about 35% of women and men aged 60 years and above had radiographic knee OA. Although the cause of OA can be many factors, such as previous injury, abnormal limb development and so on, its main symptom is a complex chronic pain condition. Previous studies have demonstrated central sensitization in OA patients. Despite the high prevalence rate of OA, the treatment of OA is far from satisfactory. Acupuncture could be a promising treatment option for knee OA due to the effectiveness of the pain relief and the rarity of adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness on KOA, a long-term follow up interventional study with clear design, standard criteria, control group, will be started to confirm the effects of long term for acupuncture treatment.

6. Conditions and Keywords

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

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Shanghai Longhua hospital

Arm Type

Active Comparator

Arm Description

Acupuncture treatments will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

Arm Title

Shanghai Guanghua hospital

Arm Type

Active Comparator

Arm Description

Acupuncture treatments will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

Arm Title

Huadong hospital of Fudan University

Arm Type

Active Comparator

Arm Description

Acupuncture treatments will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

Arm Title

Shanghai Yueyang Integrated hospital

Arm Type

Active Comparator

Arm Description

Acupuncture treatments will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

Intervention Type

Device

Intervention Name(s)

Acupuncture treatment

Intervention Description

Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

Primary Outcome Measure Information:

Title

Visual analogue scale

Description

Visual analogue scale assessed for 12 weeks

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Western Ontario and McMaster university of orthopedic index

Description

Western Ontario and McMaster university of orthopedic index assessed for 12 weeks.

Time Frame

12weeks

Title

Lequesne index

Description

Lequesne index assessed for 12 weeks.

Time Frame

12 weeks

Title

Adverse Event

Description

Adverse Event assessed for 12 weeks.

Time Frame

12 weeks

Title

The Medical Outcomes Study short form health survey-36

Description

The Medical Outcomes Study short form health survey-36 assessed for 12 weeks.

Time Frame

12 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients who have knee OA diagnosed according to the American College of Rheumatology classification criteria (with at least one osteophyte in the tibiofemoral joint and with a Kellgren-Lawrence grade of more than 2). Male and female patients who have had a history of moderate or greater knee pain of more than 3 months' duration and have reported moderate or greater, clinically significant, knee pain during most days of the last month before the interview. Male and female patients who have given their consent to participate in the study. Patients will be selected among those who are not on the waiting list for total knee arthroplasty by the traumatology unit of our hospital. Exclusion Criteria: Patients with any of the following will be excluded from the study: a history of any secondary OA associated with any systemic arthropathy (i.e., rheumatoid arthritis or gouty arthritis); Any knee treatment with steroids, methotrexate, or azathioprine; recent traumatisms caused by acupunctured insertion; A history of bleeding disorders or any disease related to acupuncture contraindications; A history of any knee injection in the previous 6 months (e.g., cortisone and hyaluronic acid); a history of morphine or morphine derivative use.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yongjun Wang, Ph.D, M.D

Phone

8618917763018

yjwang8888@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hao Xu, Ph.D, M.D

Phone

8613788951086

hoxu@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongjun Wang, Ph.D, M.D

Organizational Affiliation

Shanghai Longhua Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Longhua Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yongjun Wang, Ph.D,M.D

Phone

18917763018

yjwang8888@126.com

First Name & Middle Initial & Last Name & Degree

Hao Xu, Ph.D,M.D

Phone

13788951086

hoxu@163.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

individual participant data (IPD) available

Citations:

PubMed Identifier

24722559

Citation

Ho-Pham LT, Lai TQ, Mai LD, Doan MC, Pham HN, Nguyen TV. Prevalence of radiographic osteoarthritis of the knee and its relationship to self-reported pain. PLoS One. 2014 Apr 10;9(4):e94563. doi: 10.1371/journal.pone.0094563. eCollection 2014.

Results Reference

result

PubMed Identifier

22147711

Citation

Nguyen US, Zhang Y, Zhu Y, Niu J, Zhang B, Felson DT. Increasing prevalence of knee pain and symptomatic knee osteoarthritis: survey and cohort data. Ann Intern Med. 2011 Dec 6;155(11):725-32. doi: 10.7326/0003-4819-155-11-201112060-00004.

Results Reference

result

PubMed Identifier

23973136

Citation

Hochman JR, Davis AM, Elkayam J, Gagliese L, Hawker GA. Neuropathic pain symptoms on the modified painDETECT correlate with signs of central sensitization in knee osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1236-42. doi: 10.1016/j.joca.2013.06.023.

Results Reference

result

PubMed Identifier

22961435

Citation

Finan PH, Buenaver LF, Bounds SC, Hussain S, Park RJ, Haque UJ, Campbell CM, Haythornthwaite JA, Edwards RR, Smith MT. Discordance between pain and radiographic severity in knee osteoarthritis: findings from quantitative sensory testing of central sensitization. Arthritis Rheum. 2013 Feb;65(2):363-72. doi: 10.1002/art.34646.

Results Reference

result

PubMed Identifier

15611487

Citation

Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004 Dec 21;141(12):901-10. doi: 10.7326/0003-4819-141-12-200412210-00006.

Results Reference

result

PubMed Identifier

25268438

Citation

Hinman RS, McCrory P, Pirotta M, Relf I, Forbes A, Crossley KM, Williamson E, Kyriakides M, Novy K, Metcalf BR, Harris A, Reddy P, Conaghan PG, Bennell KL. Acupuncture for chronic knee pain: a randomized clinical trial. JAMA. 2014 Oct 1;312(13):1313-22. doi: 10.1001/jama.2014.12660.

Results Reference

result

PubMed Identifier

11532840

Citation

White A, Hayhoe S, Hart A, Ernst E. Adverse events following acupuncture: prospective survey of 32 000 consultations with doctors and physiotherapists. BMJ. 2001 Sep 1;323(7311):485-6. doi: 10.1136/bmj.323.7311.485. No abstract available.

Results Reference

result

Learn more about this trial

Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

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