Health Condition 1: null- Patients were suffering from primary osteoarthritis of knee.
Conditions
Interventions
Intervention1: Flupirtine 100 mg: One cap three times daily for twelve weeks
Control Intervention1: Tramadol hydrochloride: Opioid like analgesic
Control Intervention2: Flupirtine: Centrally acting an
Sponsors
There was no sponsor in this trial
Eligibility
Inclusion criteria
Inclusion criteria: 1.Clinically diagnosed cases of primary early symptomatic OA affecting at least one knee joint (in case of bilateral knee involvement, the more symptomatic knee was scored as the â??signal kneeâ??). 2.Sex: Either sex was included 3. Knee joint pain present for at least one month in the preceding three months with at least one of the following: morning stiffness less than 30 min or knee crepitus 4.Knee pain on movement of intensity at least 35 mm on a 100 mm in VAS scale
Exclusion criteria
Exclusion criteria: 1. Secondary OA, such as due to injury, inflammatory condition, metabolic or rheumatic disease, osteonecrosis, Pagetâ??s disease, hemophilia etc. 2. Non-OA causes of knee pain in the signal knee (e.g. bursitis, fibromyalgia, osteonecrosis, etc) 3. Prior intra-articular injection of hyaluronic acid / steroid / joint lavage in the study knee any time in the past three months. 4. Knee injury or diagnostic arthroscopy of signal knee within 6 months preceding enrollment or knee surgery (including arthroscopic surgery requiring an incision of the internal joint components) in the study knee, at anytime. 5.Severe and advanced OA disease, defined as joint space width 5. Serious concomitant disease of vital organs. 6. Subject unlikely to provide informed consent, follow the study protocol or any other criteria, which in the opinion of the investigator, was not conducive to enrollment of a particular subject into the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of flupirtine in symptomatic primary osteoarthritis of knee Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile of flupirtine in comparison with opioid-like analgesic tramadol Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Tanmoy Kanti GoswamiI
IPGME and R
Outcome results
None listed