Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT02029703
Brief Summary:
The study hypothesis is that the use of Synvisc-One will improve physical therapy compliance and performance, resulting in improved knee function and pain when compared to a group that receives a sham injection (an injection that does not have medicine) only before a standardized physical therapy regimen over 10 weeks.
Detailed Description:
This is a prospective, randomized, double-blind (subject and physical therapist), sham needle injection controlled, single center, multi-site study.
Subjects with primary osteoarthritis knee pain will be randomly assigned to a 6 ml intra-articular injection of Synvisc-One or sham needle injection.
The post-treatment course of physical therapy will begin between Day 3 and Day 14 and will last up to 12 weeks in duration (PT ends at study Week 12). Subjects are encouraged to complete between 6 and 16 physical therapy visits within 10-12 weeks of physical therapy treatment as determined by the treating Physical Therapist.
Study:
NCT02029703
Study Brief:
Protocol Section:
NCT02029703