Comparative impact of two packages of non pharmacological interventions on quality of life of knee osteoarthritis patients reporting at a tertiary care institution - A randomized control trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- •Quality of life
研究概览
简要总结
Knee osteoarthritis (KOA) is one of the common cause of disability after fourth decade of life. In India, its prevalence has been reported to be in the range of 17-61% among people aged above 50 years. Intractable pain is the most common symptom of KOA. Quality of life (QOL) of KOA patients significantly deteriorates with pain and loss of mobility causing dependence and disability. There is no permanent cure for KOA. However, long-term effects of early to moderate KOA can be managed through non surgical interventions. This includes use of non-pharmacological interventions (NPIs) comprising of patient education, a set of exercises and weight reduction etc.These are often used in conjunction with a pharmacological regimen.
In contrast to the situation in western countries, where research has been regularly conducted to evaluate the relative impact of combining a variety of non pharmacological interventions on KOA, there has not been any systematic effort in India on these lines.
Objectives:
Primary:
i) To compare the impact of two non pharmacological intervention packages on quality of life in KOA patients reporting at PGIMER Chandigarh.
Secondary:
i) To enlist and compare the components of various NPIs being prescribed to KOA patients in India.
ii) To explore the opinion of clinicians regarding the potential effectiveness of various NPIs being used for KOA patients including that of the package developed for this study
iii) To document the difficulties/problems faced by KOA patients in complying with the instructions pertaining to the NPIs given in the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Self-reported knee pain 2.Radiological /clinical grade 1, 2, 3 as per Kellgren Lawrence scale (table.
- •) certified by clinician. 3.Demonstrated minimal knee OA related dysfunction as per WOMAC score 4.Motivated and willing to alter their lifestyle and able to comply with the planned schedule for follow up.
排除标准
- •1.Candidates for surgery due to deformity or intra –articular pathology 2.Excessive obesity (BMI>40)or any co-morbidity not allowing proper exercise protocol 3.Unresolved balance disorder 4.Unresolved neurological disorder 5.History of knee surgery or knee trauma 6.Hip or ankle instability, excessive weakness 7.Hip or knee replacement 8.Intra-articular joint injection within 4 weeks of the study 9.Inadequate communication skills in Hindi /Punjabi 10.Illiterate (nor have any literate caregivers) 11.Unable to comply with exercise protocol.
- •Participants will also be excluded if they have a significant medical condition that will increase their risk of a significant adverse health event during physical activity (eg, myocardial infarction in the previous 6 months, abnormal blood pressure response to exercise, etc.); have any other known organic disease that would contraindicate safe participation in the study (eg, cancer); have a non-OA inflammatory arthropathy or another arthritic disorder (eg, rheumatoid arthritis); use oral corticosteroids regularly.
结局指标
主要结局
•Quality of life
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• 50-Foot Timed Walk,
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•Measure of function
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•Visual analogue scale
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•30-second Chair Stand Test
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•Timed up and go test
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•BMI
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次要结局
- 1.Difficulties faced by participants in complying with the intervention package.(2.Impact of KOA on daily routine, treatment taken by different agencies)