Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02948218
• Other study ID #: MCRATKO
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 16, 2016
• Last updated: October 26, 2016
• Start date: January 2017
• Est. completion date: July 2020

Study information

• Verified date: October 2016
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Yongjun Wang, Ph.D, M.D
• Phone: 8618917763018
• Email: yjwang8888[@]126.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Acupuncture treatment
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.

Locations

Country	Name	City	State
China	Longhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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 sensiti — View 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. d — View 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. — View 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.2013.0 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale	Visual analogue scale assessed for 12 weeks	12 weeks	No
Secondary	Western Ontario and McMaster university of orthopedic index	Western Ontario and McMaster university of orthopedic index assessed for 12 weeks.	12weeks	No
Secondary	Lequesne index	Lequesne index assessed for 12 weeks.	12 weeks	No
Secondary	Adverse Event	Adverse Event assessed for 12 weeks.	12 weeks	No
Secondary	The Medical Outcomes Study short form health survey-36	The Medical Outcomes Study short form health survey-36 assessed for 12 weeks.	12 weeks	No