Chronic PainRetroBlockNCT03066037
Regional-anaesthesiological Infiltration Techniques for the Management of Chronic Pain: a Retrospective Study
An observational study of Chronic Pain and Trigeminal Neuralgia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Trigeminal Neuralgia, Cluster Headache
- What is being tested?
- regional-anaesthesiological infiltration
- Type of treatment
- Surgery or procedure
- How many people
- 83 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2009to 13 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- patients with chronic pain disease undergoing regional-anaesthesiological infiltration series
Who cannot join
- pregnancy
- patients in legal custody
- age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Pain, Trigeminal Neuralgia, Cluster Headache, Post-Zoster Neuralgia, Post Zoster Pain, Neuropathic Pain
- Being tested
- regional-anaesthesiological infiltration
- Keywords
- regional-anaesthesiological infiltration, block series, invasive pain treatment
- Medical subject headings
- Chronic Pain, Trigeminal Neuralgia, Cluster Headache, Neuralgia, Postherpetic, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional-anaesthesiological infiltrationProcedure or surgery
Also called block series
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS reduction during therapy
Reduction (relative and absolute) of pain during series of infiltrations comparing NRS scores before and after infiltrations
Measured: 2 weeks
Secondary outcomes (5)
Number of blocks in a series
Number of blocks in a series to achieve the targeted NRS reduction
Measured: 4 weeks
Time till recurrent pain
Time until a new series of blocks is requested by the patient
Measured: 24 weeks
clinical course of pain
NRS development during series of infiltrations
Measured: 2 weeks
type of infiltration
location of infiltrations with medication used
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Jan 2009
- Primary completion30 Jun 2016
- Study completion13 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Tafelski, Charite University, Berlin, Germany
- Investigators
- Michael Schäfer, Prof., Principal investigator, Charité University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066037
- Sponsor's protocol ID
- RetroBlock
- Acronym
- RetroBlock
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing can be requested and will be evaluated by Charité data safety authorities.
Publications
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.
PubMed 23748119Tafelski 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.
PubMed 25479710
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional-anaesthesiological Infiltration Techniques for the Management of Chronic Pain: a Retrospective Study
- ClinicalTrials.gov ID
- NCT03066037
- Acronym / sponsor ID
- RetroBlock / RetroBlock
- Conditions
- Chronic Pain, Trigeminal Neuralgia, Cluster Headache, Post-Zoster Neuralgia, Post Zoster Pain, Neuropathic Pain
- Keywords
- regional-anaesthesiological infiltration, block series, invasive pain treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 13 Nov 2016 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- patients with chronic pain disease undergoing regional-anaesthesiological infiltration series
Key exclusion criteria (3 listed)
- pregnancy
- patients in legal custody
- age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regional-anaesthesiological infiltrationAlso: block seriesPatients 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. | Procedure or surgery | – |
Primary outcome
NRS reduction during therapy
Time frame: 2 weeks
Reduction (relative and absolute) of pain during series of infiltrations comparing NRS scores before and after infiltrations
5 secondary outcomes
Number of blocks in a series
Time frame: 4 weeks
Time till recurrent pain
Time frame: 24 weeks
clinical course of pain
Time frame: 2 weeks
type of infiltration
Time frame: 2 weeks
co-parameters of pain chronification
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Background: PubMed 23748119Dworkin 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.
- Background: PubMed 25479710Tafelski 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.
- Individual participant dataSharing planned: No. Data sharing can be requested and will be evaluated by Charité data safety authorities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Schäfer, Prof. principal investigator
Charité University Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Trigeminal Neuralgia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS reduction during therapy (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03066037, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.