Clinical trial NCT03363490: The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis
Official title: The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Therapy
Keywords: Self-Management
Neuromuscular Exercise Therapy
Knee osteoarthritis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Jishuitan Hospital
name: General Hospital of Beijing PLA Military Region
name: Peking Union Medical College Hospital
name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2017-12-06
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients of knee OA will be divided into A, B, C, D four parallel groups with fully informed, each group will enroll 100 patients, A for control group, B for neuromuscular exercise, C for self-management program, D for neuromuscular exercise and self-management program, respectively.
Primary purpose: TREATMENT

Brief summary: Osteoarthritis is the most common chronic disabling disease,the importance of patient's self-management in chronic disease has been paid more and more attention internationally. Currently, the self-management of OA patients in China is lack of instructions from professional clinicians, and leads to inappropriate excise, irregular drug medication. OAKP (Osteoarthritis of the Knee Self-Management Program) is a program initiated from University of Southern Denmark, follows clinical guidelines of OA, formatted for easy use by patients and clinicians, including customized neuromuscular exercise therapy, educational sessions of what is OA and how to control body weight to protect the knee.

The main purpose of this study is to verify the effectiveness of neuromuscular exercise therapy and OAKP, see whether it can help patients to relief the symptom and improve life quality.

Detailed description: The study plans to enroll patients above 50 years old who suffered from knee OA, but patients meets any of the exclusion criteria will not be enrolled. 400 patients of knee OA will be randomly divided into A, B, C, D four parallel groups with fully informed, each group will enroll 100 patients, A for control group, B for neuromuscular exercise, C for self-management program, D for neuromuscular exercise and self-management program, respectively. Each collaborate hospital would enroll patients as a multicenter clinical trial. Patient will receive a baseline and 3m, 6m, 12m follow-up evaluation of their knee physical function. Primary outcome measure is KOOS (Knee Injury and Osteoarthritis Outcome Score), secondary evaluation include VAS, EQ-5D, Arthritis self-efficacy score, 6-minutes Walk test, TUG test, 20 meters quick walk test,Stand up test in 30 seconds, Balance test, Kellgren\& Lawrence（KL）, Pain medication. Outcome will compare the mean difference between baseline survey and 12 months of follow-up in each group, using t-test or chi-square test,respectively.

Eligibility criteria: Inclusion Criteria:

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1.Clinical diagnosis of knee osteoarthritis, Diagnostic criteria is based on the Chinese medical association's 2007 diagnosis and treatment guidelines for osteoarthritis:

1. Repeated knee joint pain within 1 month;
2. X-ray(weight-bearing or not)shows narrowed joint space,sclerosis and (or) cystic degeneration of subchondral bone, osteophytes of the joints;
3. The joint fluid (at least twice) is clear and viscous, WBC\<2000个/ml;
4. Age of patients ≥40 yrs;
5. Morning stiffness≤3 min;
6. Bone friction in the activity; Note：Combine clinical feature, laboratory and X-ray examination,when the patients meet(1)+(2) or (1)+(3)+(5)+(6) or (1)+(4)+(5)+(6)，they can be diagnosis as knee osteoarthritis.

2.VAS≥4分; 3.No surgical treatment is planned within 6 months;

Exclusion Criteria:

1. Other types of arthritis, such us RA(rheumatoid arthritis)
2. Severe deformity of knee joint;
3. Over obesity patients（BMI\>35）;
4. Other comorbidities that would severely affect somatic function, such as: cerebral infarction, lumbar disease that meets surgical indications, lower extremity angiopathy;
5. Decompensated cardiac dysfunction;
6. Severe cardiovascular and cerebrovascular diseases, or the patient is too weak for any kinds of exercise;
7. Lack of compliance;

Primary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC
timeFrame: Baseline, 3 months, 6 months, 12months
Secondary outcomes:
measure: Visual Analog Score（VAS）
timeFrame: Baseline, 3 months, 6 months, 12months
measure: EuroQol Five Dimensions Questionnaire（EQ-5D）
timeFrame: Baseline, 3 months, 6 months, 12months
measure: Kellgren& Lawrence（KL）
timeFrame: Baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: PekingUPH
state: Beijing
Study officials:
affiliation: arthritic clinic and research center
name: Jianhao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ageberg E, Roos EM. Neuromuscular exercise as treatment of degenerative knee disease. Exerc Sport Sci Rev. 2015 Jan;43(1):14-22. doi: 10.1249/JES.0000000000000030.