Health Condition 1: M255- Pain in joint
Conditions
Interventions
Intervention1: Intra-articular hyaluronic acid: A single dose, 90mg/3ml will be administered to the wrist, elbow, shoulder, or hip, as appropriate for the participant s diagnosed joint condition.
Cont
Sponsors
BIOTECH VISION CARE PVT. LTD
Eligibility
Inclusion criteria
Inclusion criteria: Mild to moderate documented diagnosis of osteoarthritis that fulfill the ACR (American College of Rheumatology) criteria. Patients with consistent symptoms (joint pain, crepitus, swelling, effusion alone or combination of these symptoms). Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication taken for any condition, including their pain. However, patients will be allowed to use only acetaminophen or aspirin as a rescue pain medication during the study period. The patients must abstain from medication use 24 hours prior to any study visit. greater then or equal to 50/100 VAS pain as a result of wrist, elbow, shoulder and hip joint disorders. More then or equals to 3 months of pain after onset of symptoms that has failed conservative treatments (e.g., medications, physical therapy)
Exclusion criteria
Exclusion criteria: Pregnant or lactating women and women of childbearing potential not willing to use adequate contraception. Patients unable to stay in the study for 6 months, non- cooperating, not able to understand. Patients having previously undergone surgery on target joint, including arthroscopy. Patients with neurological deficit, with primary inflammatory joint disease, intra-articular tumors. Any severe systemic disease(s). Patients who have received intra-articular hyaluronic acid within the previous 6 months and/or intra-articular steroids or articular lavage in the target joint within the previous 3 months prior to their inclusion in the study. Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study. History of allergy or hypersensitivity to hyaluronic acid. Participation in any clinical study in the last 3 months and any surgery scheduled in the next 8 months that can affect directly the result of the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) Pain rating Range of Motion (ROM) of Wrist/Elbow/Shoulder/Ankle/Small Joints (Fingers and Toes) All Adverse Events Timepoint: Time Frame: At baseline (pre-intervention), 7days and 1 Month At baseline (pre-intervention), 7D, and 1 Month Through 6 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) Pain rating Timepoint: 3 Months, 6 Months;SF-12Timepoint: At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months;Range of Motion (ROM) of Wrist/Elbow/Shoulder/Ankle/Small Joints (Fingers & Toes) Timepoint: 3 Months, 6 Months;American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment formTimepoint: At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months;FIHOATimepoint: At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months;Numeric Rating Scale (NRS)Timepoint: At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months;American Orthopedic Foot & Ankle Society (AOFAS)Timepoint: At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months;Ankle Osteoarthritis Scale (AOS)Timepoint: At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months;Michigan Hand Outcomes Questionnaire (MHQ)Timepoint: At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months | — |
Countries
India
Contacts
Public ContactBhargav Joshi
BIO-TECH VISION CARE PVT. LTD
Outcome results
None listed