An observational study in Complex Regional Pain Syndrome Type I, sponsored by Elsan. Recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by Elsan · Observational
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Among 17 studies in Complex Regional Pain Syndromes with a site in France — 6 open to participants now, 6 under way, none of them phase 3. Complex Regional Pain Syndromes · France.
Among the 17 studies in Complex Regional Pain Syndromes with a site in France, this one is one of 2 that started in 2023, is one of 4 observational ones, and was the 14th registered.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
Browse Complex Regional Pain Syndromes studies →6 of the 17 studies in Complex Regional Pain Syndromes with a site in France are open now. Recruiting first, the newest first:
Polyclinique de l'Europe · Sites in France
Ages 18+
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est · Sites in France
Ages 18+ · Healthy volunteers
Hospices Civils de Lyon · Sites in France
Ages 12–20
Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape · Sites in France
Ages 18+
Nantes University Hospital · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 3
First in 2012; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 58 across 44 observational studies indexed under Complex Regional Pain Syndromes.
Median enrollment 60 across the 13 interventional studies, 33 across the 4 observational. Of the 11 that completed or were terminated, 1 (9%) have results posted.
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1 of 17 have an industry lead sponsor. The 10 most frequent:
Elsan is the lead sponsor of 68 studies on the registry; 35 are open to participants now.
Elsan has 1 study filed under Complex Regional Pain Syndromes — fewer than ten, so there is no comparison to draw.
2 of the studies in Complex Regional Pain Syndromes with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07361692Polyclinique de l'EuropeEffectiveness of Transcranial Direct Current Stimulation (tDCS) in the Management of Complex Regional Pain Syndrome | 2027-06-01 |
| NCT07349173Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstPeripersonal Space Representation in Upper Limb Segmental Exclusion | 2027-07 |
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Among the 17 studies in Complex Regional Pain Syndromes with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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In this study, it is the procedure of spinal cord stimulation in Burst mode, its results and the experience of the patients that are evaluated.
There is 1 "classic" spinal cord stimulation setting that can be problematic in the case of cervical spinal cord stimulation because neck movements tend to trigger paresthesias. It is therefore possible, in a certain number of cases, that these side effects prevent the treatment from being effective. Thus, the development of new modes of spinal cord stimulation, mainly aiming at eliminating these side effects, has proven to be particularly interesting.
There are 3 new modes of stimulation: high frequency stimulation which uses very short pulse durations and a stimulation frequency of the order of 1000 Hz, high density stimulation which uses long duration pulses and an intermediate stimulation frequency, and "Burst" stimulation which uses stimulation trains repeated 40 times per second.
The Burst stimulation mode preferentially activates pathways in the medial part of the pain matrix, leading mainly to the cingulate cortex involved in modulating the affective, emotional and attentional side of pain. This result should theoretically be felt positively by the patient and his entourage, and the benefit should persist, or even improve with time, contrary to what is often observed with other stimulation modes.
In addition, the Burst mode consumes little energy, theoretically less than conventional stimulation. It is therefore not necessary to use rechargeable stimulators, which provides greater comfort for the patient.
Patient with Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs, eligible for implantation of a medullary stimulator
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients treated by Spinal Cord Stimulation in Burst Mode for their Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs
Device: Implantable spinal cord stimulator
Spinal cord stimulation is possible thanks to implantable spinal cord neurostimulators. These are medical devices, which include a stimulation electrode and an implantable box, designed to deliver electrical stimulation for pain relief. The electrode is implanted in the epidural space in order to stimulate the posterior cords of the spinal cord through the dura mater, at the dorsal or cervical level.
Pain assessment at 3 months after implant
The analgesic outcome of spinal cord stimulation will be assessed by comparing the preoperative visual analogue pain scales (VAS) (ranging from 0: "No pain" to 100: "Maximum pain imaginable") to those performed at the 3rd month visit (3 months). Patients with a VAS score of 50% or more improvement will be considered "improved". The VAS value retained corresponds to the average of 3 values taken during the day (morning, noon and evening).
Time frame: 3 months
procedure assesment
By using: - VAS (ranging from 0: "No pain" to 100: "Maximum pain imaginable")
Time frame: 1 month, 3 months, 6 months and 12 months
Assessing attention and working memory
By using: - Trail Making Test (Reitan RM 1958) (2 parts A and B measured in seconds: The maximum score for part A is 100", 101" indicating that the test was not completed. The maximum score for Part B is 300", 301" indicating that the test was not completed)
Time frame: 3 months and 12 months
qualitatively evaluate the effectiveness of the procedure
Semi-structured interviews with patients and their families oriented towards the evaluation of attention, affectivity and emotions.
Time frame: 3 months
Medication use
Medication quantification scale (MQS) (Harden RN 2005): ranging from 0 (no antalgic medication used) to 126 (maximum antalgic medication used)
Time frame: 1 month, 3 months, 6 months and 12 months
procedure assesment
By using: - Hospital Anxiety and Depression scale (HAD) (Mykletun A 2001) (2 columns ranging from 0 " no or few anxiety" to 21 "high anxiety"
Time frame: 1 month, 3 months, 6 months and 12 months
procedure assesment
By using: - Global Perceived Effect scale (GPE, Kamper SJ 2010) (ranging from 1 "very bad" to 7 "very good")
Time frame: 1 month, 3 months, 6 months and 12 months
Assessing attention and working memory
By using: - WAIS-IV (Benson N 2010) ( 4 subtests submited with 10 items in all (ranging 0 to 19 each), to calculate intelligence quotient with a minimum at 0 and a maximum at 190)
Time frame: 3 months and 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Dec 2024, 15 months after the start.
Of 18 observational studies under Complex Regional Pain Syndromes, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 147. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
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Complex Regional Pain Syndromes →
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