Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to better understand how people feel after a radiofrequency ablation standard of care surgery using a different type of needle (multi-tined expandable electrode/MEE) in comparison to receiving conventional medical management (CMM) techniques.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation (RFA) with MEE | Active Comparator | Radiofrequency ablation involves a minimally invasive procedural technique. It uses radiofrequency waves to burn the nerve causing pain. This nerve will no longer be able to send pain signals to your brain. For this study, the multi-tined expandable electrode needle will be used. This needle will result in a larger treatment area. This may result in better pain relief and longer lasting pain relief. If you undergo the radiofrequency ablation procedure you will have pain medication injected where the ablation will be done. The procedure will take about 20 mins to complete. You will be allowed to go home afterward. |
|
| Conventional Medical Management (CMM) Treatment Only | Active Comparator | Your current standard of care treatment may already consist of some CMM therapies. Standard of care includes a variety of intervention types such as medication, physical therapy, home exercise programs, back brace, walking aid, and chiropractic care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation with MEE | Procedure | RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean visual analog scale (VAS) between the two group | will be compared using an independent samples t-test | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Observe the incidence of complications associated with MEE while utilizing this device | Number of complications will be analyzed using Independent samples T-Test if there is a normal distribution of complications. In the event of a binary outcome for complications, Chi-square Test will be used. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angie Ballew, DC, MS | Contact | (913) 945-7420 | aballew@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dawood Sayed, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional Medical Management | Behavioral | Conventional medical management (CMM), which may include physical therapy, home exercise programs, pain medication, and other conservative therapies such as back brace, walking aid, and chiropractic care. |
|
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided