The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis

Peking University

Status: Unknown

Conditions: Exercise Therapy

Treatments: Behavioral: Self-management program; Behavioral: Neuromuscular exercise therapy; Behavioral: Health education

Study type: Interventional

Funder types: Other

Identifiers

NCT03363490

PLSKNLSMFS2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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400 participants in 4 patient groups

Control

Other group

Description:

The patients in this group will only receive health education intervention.

Treatment:

Behavioral: Health education

Neuromuscular exercise therapy

Other group

Description:

The patients in this group will receive exercise therapy intervention.Besides, health education will be performed for every group.

Treatment:

Behavioral: Health education

Behavioral: Neuromuscular exercise therapy

Self-management program

Other group

Description:

The patients in this group will receive self-management intervention.Besides, health education will be performed for every group.

Treatment:

Behavioral: Health education

Behavioral: Self-management program

Exercise therapy+self-management

Other group

Description:

The patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group.

Treatment:

Behavioral: Health education

Behavioral: Neuromuscular exercise therapy

Behavioral: Self-management program