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

Not Applicable

• Conditions: Exercise Therapy
• Interventions: Behavioral: Health education; Behavioral: Self-management program; Behavioral: Neuromuscular exercise therapy

• Registration Number: NCT03363490
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2017-11-26
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-06
• Status Verified: 2018-04
• Study Start: 2018-04-01
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-06
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control	Health education	The patients in this group will only receive health education intervention.
Exercise therapy+self-management	Self-management program	The patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group.
Exercise therapy+self-management	Neuromuscular exercise therapy	The patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group.
Self-management program	Health education	The patients in this group will receive self-management intervention.Besides, health education will be performed for every group.
Self-management program	Self-management program	The patients in this group will receive self-management intervention.Besides, health education will be performed for every group.
Exercise therapy+self-management	Health education	The patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group.
Neuromuscular exercise therapy	Neuromuscular exercise therapy	The patients in this group will receive exercise therapy intervention.Besides, health education will be performed for every group.
Neuromuscular exercise therapy	Health education	The patients in this group will receive exercise therapy intervention.Besides, health education will be performed for every group.

Primary Outcome Measures

Name	Time	Method
The Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC	Baseline, 3 months, 6 months, 12months	WOMAC grade is a reliable knee osteoarthritis patients' self-reported therapeutic effect evaluation system, including three dimensions: pain, stiffness, daily activities and quality of life, and each dimension includes several questions scale from 0(worst) to 4(best) , total score of each dimension range from zero (worst) to 100 (best). Score of each question add together will be the total score. Baseline, 3 months, 6 months, 12 months, through visit or telephone follow-up will be recorded. Compare the mean difference of WOMAC grade between baseline survey and 12 months of follow-up in each group.

Secondary Outcome Measures

Name	Time	Method
EuroQol Five Dimensions Questionnaire（EQ-5D）	Baseline, 3 months, 6 months, 12months	EQ-5D is a scale to extimate health condition and quality of life, and its score ranges from -0.6 to 1.0. The higher the score is, the healthier the patient is.
Kellgren& Lawrence（KL）	Baseline	The higher the KL score is ,the more severe the patient is. Baseline,through visit or telephone follow-up.
Visual Analog Score（VAS）	Baseline, 3 months, 6 months, 12months	Visual Analogue Scale of pain is a scale to extimate pain, and its score ranges from 0(worst) to 10(best). The higher the score is, the more severe pain the patient is feeling.

Trial Locations

Locations (1)

PekingUPH; 🇨🇳 Beijing, Beijing, China