Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085722
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2004-06-14
Brief Title:
Joint Injections for Osteoarthritic Knee Pain
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
The Efficacy of Prolotherapy in Osteoarthritic Knee Pain
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether prolotherapy PrT a therapy based on injection of a sugar solution in and around the knee can decrease pain and disability from knee osteoarthritis OA
Detailed Description:
OA is a common debilitating condition for which there is no cure and no known cause Prolotherapy PrT is an injection-based therapy for chronic musculoskeletal pain in which an irritant solution is injected at painful ligaments and tendons to produce stronger connective tissue and decrease pain Although limited studies suggest PrT is effective may be effective for low back pain its use has not been rigorously studied in human clinical trials for osteoarthritis
Participants in this study will be randomly assigned to receive one of three treatments standard PrT injections with a saline placebo or a pamphlet with recommendations for home knee physical therapy Injections will be given at Weeks 1 5 and 9 injection group subjects will have the option to receive an additional 2 sets of injections All participants will be assessed for a total of 1 year A set of disease-specific and general quality-of-life questionnaires will be used to assess participants outcomes A randomized subset of participants N38will receive magnetic resonance imaging MRIof the knee at baseline and 52 weeks At study completion participants who did not receive PrT will have the option to receive up to five sessions of PrT at no cost Data will be collected for this group minus MRI and will be analyzed separately Enrollment is limited to residents of Southern Wisconsin
Participants in this study will be randomly assigned to receive one of three treatments standard PrT injections with a saline placebo or a pamphlet with recommendations for home knee physical therapy Injections will be given at Weeks 1 5 and 9 injection group subjects will have the option to receive an additional 2 sets of injections All participants will be assessed for a total of 1 year A set of disease-specific and general quality-of-life questionnaires will be used to assess participants outcomes A randomized subset of participants N38will receive magnetic resonance imaging MRIof the knee at baseline and 52 weeks At study completion participants who did not receive PrT will have the option to receive up to five sessions of PrT at no cost Data will be collected for this group minus MRI and will be analyzed separately Enrollment is limited to residents of Southern Wisconsin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23AT001879-01 | NIH | None | httpsreporternihgovquickSearchK23AT001879-01 |