A prospective, randomized, observer blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of a Myostaal liniment application as addon therapy for muscle strengthening in participant suffering from osteoarthritis of knee
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy in terms of Force generation (strength of muscle) with the help of a push-pull dynamometer Baseline to day 90 with Myostaal liniment application along with physiotherapy in participants suffering from knee joint osteoarthritis incomparison to only physiotherapy given group
研究概览
简要总结
A prospective, active-controlled, randomized, observer blind,comparative, parallel, 2-arm study will be conducted on 60 participants suffering from osteoarthritis of knee evaluate the efficacy and safety of a Myostaal liniment application.
Participant attending Orthopaedics OPD with a history of osteoarthritis knee and referred to physiotherapy OPD for physiotherapy, satisfying the selection criteria will be selected. All participants who voluntarily agree to participate and provide written informed consent for participation will be recruited in the study. Detailed personal, present and past medical history will be taken. Thorough physical examination, which includes vital variables, systemic examination, weight and demographics will be recorded and this will be called as a screening visit. Once the laboratory blood investigational reports satisfying the inclusion criteria are met, then these participants will be randomized into 2 different groups on Day 0. Group 1, will be given Myostaal liniment application along with physiotherapy for 90 days and Group 2 will be given physiotherapy only for 90 days. On day 0, Baseline WOMAC index score and VAS score, Lequesne severity index score, 5 times sit to stand test, 6 minutes’ walk test and single leg stance test will be done and baseline values will be recorded. All the participants will be given Tab Paracetamol 650mg (Tab. Paracip 650 mg) to be taken as and when required in case of severe pain. All the patients will be asked to follow up in physiotherapy OPD on day 15, day 30, day 60 and day 90. At each visit, a complete physical examination will be done by the physician. The participants will be assessed for the WOMAC index score, VAS score, Lequesne severity index score, 6 minutes’ walk test, 5 times sit to stand test, single leg stance test and participant’s global assessment score and will be documented in CRF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed case of Idiopathic knee osteoarthritis for minimum 1month and maximum 5 years according to clinical guidelines of American college of Rheumatology. The guidelines include patient currently experiencing pain in one or both the knees with at least 3 out of the following 6 features:.
- •Age 40 – 70 years.
- •Morning stiffness within 30 minutes of walking.
- •Bony tenderness.
- •Bony enlargement.
- •No palpable warmth
- •Participant having baseline knee joint pain more than 40 mm on Visual Analogue Scale (VAS) either at rest or on weight bearing activities (e.g., walking, standing, climbing staircase) during the preceding 24 hours. 4.Participants willing to give written informed consent.
- •Participants willing to follow up.
排除标准
- •Participants with secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, postinfectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement)
- •Participants on corticosteroid use: (a) oral corticosteroid within the previous 14 days, or (b) intramuscular corticosteroid within 30 days, or (c) intra-articular corticosteroid into the study knee within 90 days, or (d) intra-articular corticosteroid into any other joint within 30 days, or (e) topical corticosteroid at the site of application within 14 days; Or patient requiring systemic corticosteroids during the course of study.
- •Participants on NSAIDS use will be excluded.
- •Participants who has undergone or who is planning to undergo surgery in next 3 months will be excluded from the study
- •Participants who has underwent knee replacement surgery for the affected knee and who have undergone a knee arthroscopy within past 2 years.
- •Also, Patient with intra-articular visco supplementation (e.g., SynviscR) in the affected knee joint in the preceding 6 months
- •Participants with on-going use of medication including oral muscle relaxants, or low-dose antidepressant for any chronic pain management
- •Participants with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
- •Participants with history of clinically-active renal, hepatic or peptic ulcer disease
- •History of life threatening cardiovascular and /or neurological event in the past one year.
- •Participants with history of alcohol or drug abuse, bleeding disorder
- •Participants having any severe active infectious disease requiring hospitalization.
- •Pregnancy or lactation.
- •Participants who has taken any herbal medication in the past 4 weeks.
- •Participants participating in another investigational drug trial in the previous 30 days.
- •Participants who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
- •History of HIV or any immune deficient conditions.
结局指标
主要结局
To evaluate the efficacy in terms of Force generation (strength of muscle) with the help of a push-pull dynamometer Baseline to day 90 with Myostaal liniment application along with physiotherapy in participants suffering from knee joint osteoarthritis incomparison to only physiotherapy given group
时间窗: Day0 Day15 Day30 Day60 Day90
次要结局
- A)Push-pull leg dynamometer(B)WOMAC functional subscale sore)