Comparison Between Two Painkillers,Flupirtine and Tramadol in Osteoarthritis of Knee

Phase 4

Completed

• Conditions: Health Condition 1: null- Patients were suffering from primary osteoarthritis of knee.

• Registration Number: CTRI/2017/10/010142
• Lead Sponsor: There was no sponsor in this trial

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-09-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

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

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 < 2 mm or deformed joint, or disease necessitating knee surgery in the current year.

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of flupirtine in symptomatic primary osteoarthritis of knee <br/ ><br>Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Safety profile of flupirtine <br/ ><br>in comparison with opioid-like analgesic tramadol <br/ ><br> <br/ ><br>Timepoint: 12 weeks