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The first clinical research effort under this initiative is a pilot randomized controlled trial comparing intra-periarticular lumbar facet platelet-rich plasma (PRP) injection to standard-of-care medial branch radiofrequency ablation (RFA) for chronic lumbar facet-mediated pain.
The study is designed to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-Rich-Plasma Injection | Experimental | Participants will receive fluoroscopically guided intra-periarticular lumbar facet platelet-rich plasma (PRP) injection for the treatment of chronic lumbar facet-mediated pain. |
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| Radiofrequency Ablation | Active Comparator | Participants will undergo lumbar medial branch radiofrequency ablation (RFA) for the treatment of chronic lumbar facet-mediated pain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma Joint Injection | Procedure | Autologous platelet-rich plasma (PRP) will be prepared using the Arthrex ACP double-syringe system according to manufacturer instructions. PRP will be injected into the lumbar facet joint and/or periarticular region under fluoroscopic guidance using sterile technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale on Pain Level | Range: 0-10 Higher score means more painful. | 4 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale on Pain Level | Range: 0-10 Higher score means more painful. | 1 month post-treatment |
| Oswestry Disability Index | Range: 0-100% Higher score means greater disability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruijia Niu | Contact | 617-754-6732 | research@nebh.org |
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| Medial branch radiofrequency ablation | Procedure | Lumbar medial branch radiofrequency ablation will be performed under fluoroscopic guidance using standard thermal radiofrequency lesioning techniques targeting the medial branch nerves supplying the symptomatic lumbar facet joints. |
|
| 1 Month post-procedure |
| Patient Global Impression of Change | 7-point Likert scale 1 = very much improved, 7 = very much worse | 1 month post-procedure |
| Oswestry Disability Index | Range: 0-100% Higher score means greater disability. | 4 months post-procedure |
| Patient Global Impression of Change | 7-point Likert scale 1 = very much improved, 7 = very much worse | 4 months post-procedure |
| Numeric Rating Scale on Pain Level | Range: 0-10 Higher score means more painful. | 6 months post-treatment |
| Oswestry Disability Index | Range: 0-100% Higher score means greater disability. | 6 months post-procedure |
| Patient Global Impression of Change | 7-point Likert scale 1 = very much improved, 7 = very much worse | 6 months post-procedure |
| Numeric Rating Scale on Pain Level | Range: 0-10 Higher score means more painful. | 12 months post-treatment |
| Oswestry Disability Index | Range: 0-100% Higher score means greater disability. | 12 months post-procedure |
| Patient Global Impression of Change | 7-point Likert scale 1 = very much improved, 7 = very much worse | 12 months post-procedure |