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Spontaneous intracranial hypotension (SIH) is a condition characterized by refractory orthostatic headache, mostly due to leaks of cerebrospinal fluid (CSF). Epidural patch with autologous platelet-rich plasma (PRP), which contains numerous growth factors and cytokines, has been reported as a new and promising alternative for current standard whole blood patching. However, there is no study comparing the efficacy and safety of the two approaches. In this study, we aimed to provide data concerning the outcomes of PRP patching versus conventional whole blood patching for treatment of refractory SIH cases failing in conservative therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP Patch (PP) | Experimental |
| |
| Whole blood patch (WP) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP Patch group | Procedure | Autologous PRP was prepared with the 2-stage centrifugation method and mixed with iohexol contrast. We chose two separate sites for epidural access. A standard epidural puncture was conducted under the guidance of CT. The PRP mixture was titrated slowly into the epidural space and must be stopped immediately to patient's perception of backache or irradiating pain. A strict bed stay for 48 h was prescribed in supine position postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| The complete relief rate of patients with SIH | The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally. | At 3 months after first epidural patch |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity of orthostatic headache | Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain). | At 48 hours, 2 weeks, 3 and 6 months after first epidural patch |
| The complete relief rate of patients with SIH |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D019585 | Intracranial Hypotension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Whole Blood Patch Group | Procedure | Autologous whole blood was prepared and mixed with iohexol contrast. We chose two separate sites for epidural access. A standard epidural puncture was conducted under the guidance of CT. The whole blood mixture was titrated slowly into the epidural space and must be stopped immediately to patient's perception of backache or irradiating pain. A strict bed stay for 48 h was prescribed in supine position postoperatively. |
|
The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally. |
| At 48 hours, 2 weeks and 6 months after first epidural patch |
| The good response rate of patients with SIH. | Good response was defined as a headache reduction of at least 50%, with improvement of orthostatic component post-procedurally. | At 48 hours, 2 weeks, 3 and 6 months after first epidural patch |
| The failure rate in each group. | Failure was defined as a persistent or worsening symptom with less than 50% of headache reduction within 72 hour post-procedurally. | At 6 months after first epidural patch |
| The recurrence rate in each group. | Recurrence was defined as fresh onset of orthostatic headache in completely relieved patients beyond the 72-hour mark. | At 6 months after first epidural patch |
| Patients'quality of life | Patients'quality of life was evaluated by Headache Impact Test (HIT-6), with six item scores of headache-related disability divided into 36-49 (little or no impact), 50-55 (some impact), 56-59 (substantial impact), and ≥60 (severe impact). | At 3 and 6 months after first epidural patch |
| Patients' overall satisfaction | Patients' overall satisfaction was graded into very unsatisfactory (1), unsatisfactory (2), neutral (3), satisfactory (4) and very satisfactory (5), according to the Likert scale. | At 6 months after first epidural patch |
| The occurrence of complications in each group. | During and after first epidural patch until the end of 6-month follow up. |
| The percent of patients requiring repeat epidural patch in each group | Within 6- month follow up |