Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Unilateral or Bilateral KOA 2.Diagnosed patients of KOA based on clinical and or radiographic criteria such as those established by the American College of Rheumatology (ACR) 3.Patient classified as grade 2 or 3 for KOA according to the Kellgren Lawrence Grading System 4.Radiographic Evidence presence of characteristic changes on knee X-rays such as joint space narrowing, osteophytes, and subchondral bone changes 5.Symptoms persisting for a specified period often at least six months 6.At screening, patients on any analgesic anti-inflammatory medication shall be screened on the Visual Analogue Scale (VAS) of pain after walking on a 50 ft. flat surface of more than30 mm but less than 90 mm using a 100 mm scale. If patients taking no analgesic anti-inflammatory medication in the previous 3 days from screening then they should have a VAS pain score after walking on a 50 ft. flat surface of more than 40 mm but less than 90 mm If bilateral knee pain is present the more painful knee will be selected 7.Patient who can perform the 50 ft walk test without the support of crutches or other assistive devices 8.Patients who are willing to discontinue all NSAIDs or other analgesic medication taken for any other condition, including their knee pain 9.Patient fulfilling the inclusion criteria and agree to follow the protocol 10.Willingness and ability to comply with study requirements including attending study visits and completing assessments
Exclusion criteria
Exclusion criteria: Pregnant & lactating women Patients participating in an experimental device, study or any clinical trial within the previous 30 days before screening Other types of arthritis (Rheumatoid Arthritis, Gout) etc Osteoporosis, Venous disorders. Any knee surgery in the previous three months. Use of oral corticosteroids within the past 3 weeks Intra articular depo corticosteroids within the previous 3 months or intra articular hyaluronate within the previous 3 months Arthroscopy of the knee within the previous year. Patient with Kellgren Lawrence Grade 0, 1 and Grade 4 KOA Concomitant skin disease at the application site. Significant injury to the knee within the previous 6 months or a rash or open wound over the knee. Patients with any intercurrent disease or condition that may interfere with the free use and evaluation of the affected knee and may predispose them to a high probability of interfering with the follow up (Neurological problems, Severe Congenital Defects, Peptic Ulcer, Severe Liver Diseases, Severe Coronary Diseases, Renal Diseases, Active Psychiatric Disorders, or other clinically significant conditions). Patients who will be unwilling to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.KOOS Index 2.VAS 3.Active Range of Motion (AROM) 4.Eight-meter walk testTimepoint: On Day 7,14,28 and 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of lifeTimepoint: On Day 7,14,28 and 35 | — |
Countries
India
Contacts
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital