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There is a significant debate whether local infiltration techniques may be a method to treat complicated chronic pain syndromes, e.g. refractory headache. Until now there is a lack of evidence regarding efficacy of this treatment especially in long term follow up. Similarly, indication and management are under debate. Aim of this trial is to analyse pain scores during first treatment with anaesthesiological infiltration series.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regional-anaesthesiological infiltration | Procedure | Patients with therapy refractory chronic pain are treated with local infiltration techniques using e.g. local anaesthetics, opioids or drug combinations. Targeted structures are e.g. Ganglion stellatum, Ganglion pterygopallatinum, Trigeminal nerve branches (V1-V3). Patients receive a context- sensitive number of blocks in a series of infiltrations depenting on their pain course. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NRS reduction during therapy | Reduction (relative and absolute) of pain during series of infiltrations comparing NRS scores before and after infiltrations | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of blocks in a series | Number of blocks in a series to achieve the targeted NRS reduction | 4 weeks |
| Time till recurrent pain | Time until a new series of blocks is requested by the patient |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are included with any refractory neuropathy, refractory headache or chronic disease with any invasive pain infiltration technique applied. All infiltration series are embedded in multi-modal therapy concepts.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Schäfer, Prof. | Charité University Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité hospital | Berlin | State of Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23748119 | Background | Dworkin RH, O'Connor AB, Kent J, Mackey SC, Raja SN, Stacey BR, Levy RM, Backonja M, Baron R, Harke H, Loeser JD, Treede RD, Turk DC, Wells CD. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. 2013 Nov;154(11):2249-2261. doi: 10.1016/j.pain.2013.06.004. Epub 2013 Jun 6. | |
| 25479710 | Background |
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Data sharing can be requested and will be evaluated by Charité data safety authorities.
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| 24 weeks |
| clinical course of pain | NRS development during series of infiltrations | 2 weeks |
| type of infiltration | location of infiltrations with medication used | 2 weeks |
| co-parameters of pain chronification | co-factors of pain like co-morbidity, duration of pain disease, psychological diseases and association with primary outcome | 2 weeks |
| Tafelski S, Beutlhauser T, Gouliou-Mayerhauser E, Fritzsche T, Denke C, Schafer M. [Practice of regional anesthesia for chronic pain patients in specialized pain services : A nationwide survey in Germany]. Schmerz. 2015 Apr;29(2):186-94. doi: 10.1007/s00482-014-1503-6. German. |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D014277 | Trigeminal Neuralgia |
| D003027 | Cluster Headache |
| D051474 | Neuralgia, Postherpetic |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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