Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

NCT02948218 | Unknown Phase 3 DMC

• 1 other identifier: MCRATKO
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  Visual analogue scale assessed for 12 weeks

  12 weeks

Secondary Outcomes (4)

• Western Ontario and McMaster university of orthopedic index

  12weeks

• Lequesne index

  12 weeks

• Adverse Event

  12 weeks

• The Medical Outcomes Study short form health survey-36

  12 weeks

Study Arms (4)

Shanghai Longhua hospital

ACTIVE COMPARATOR

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.

Device: Acupuncture treatment

Shanghai Guanghua hospital

ACTIVE COMPARATOR

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.

Device: Acupuncture treatment

Huadong hospital of Fudan University

ACTIVE COMPARATOR

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.

Device: Acupuncture treatment

Shanghai Yueyang Integrated hospital

ACTIVE COMPARATOR

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.

Device: Acupuncture treatment

Interventions

Acupuncture treatment DEVICE

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.

Huadong hospital of Fudan University; Shanghai Guanghua hospital; Shanghai Longhua hospital; Shanghai Yueyang Integrated hospital

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Longhua Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (7)

• 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.

  PMID: 24722559 RESULT

• 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.

  PMID: 22147711 RESULT

• 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.

  PMID: 23973136 RESULT

• 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.

  PMID: 22961435 RESULT

• 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.

  PMID: 15611487 RESULT

• 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.

  PMID: 25268438 RESULT

• 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.

  PMID: 11532840 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yongjun Wang, Ph.D, M.D

  Shanghai Longhua Hospital

  STUDY DIRECTOR

Central Study Contacts

Yongjun Wang, Ph.D, M.D

CONTACT

8618917763018; yjwang8888@126.com

Hao Xu, Ph.D, M.D

CONTACT

8613788951086; hoxu@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2016
• First Posted: October 28, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)