Complex Regional Pain Syndrome Type I Clinical Trial
— STIMBURSTOfficial title:
Observational, Prospective, Monocentric Study Aimed at Studying the Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes (CRPS) Type 1 of the Upper Limbs Evaluation Protocol by Quantitative and Qualitative Method
Verified date | September 2023 |
Source | Elsan |
Contact | Vincent WYART, MSc |
Phone | 0240958176 |
vincent.wyart[@]elsan.care | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients between 18 and 75 years of age - Patient with CRPS of at least one upper limb - Patient affiliated to a Social Security plan - Patient who has signed and dated the no-objection form - Patient with the cognitive ability to understand the treatment and complete the questionnaires - Patient who can be followed for a minimum of 1 year Exclusion Criteria: - Patient with an uncontrolled infection - Pregnant or breastfeeding patient - Patient who has already undergone treatment by spinal cord stimulation - Patient with a contraindication to the percutaneous technique (cervical spine surgery, infection...) - Patient who cannot be followed regularly for psychological, social, family or geographical reasons - Protected participant: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision. |
Country | Name | City | State |
---|---|---|---|
France | Clinique BRETECHE | Nantes |
Lead Sponsor | Collaborator |
---|---|
Elsan | Abbott |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 3 months | |
Secondary | procedure assesment | By using:
- VAS (ranging from 0: "No pain" to 100: "Maximum pain imaginable") |
1 month, 3 months, 6 months and 12 months | |
Secondary | 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) |
3 months and 12 months | |
Secondary | qualitatively evaluate the effectiveness of the procedure | Semi-structured interviews with patients and their families oriented towards the evaluation of attention, affectivity and emotions. | 3 months | |
Secondary | Medication use | Medication quantification scale (MQS) (Harden RN 2005): ranging from 0 (no antalgic medication used) to 126 (maximum antalgic medication used) | 1 month, 3 months, 6 months and 12 months | |
Secondary | 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" |
1 month, 3 months, 6 months and 12 months | |
Secondary | procedure assesment | By using:
- Global Perceived Effect scale (GPE, Kamper SJ 2010) (ranging from 1 "very bad" to 7 "very good") |
1 month, 3 months, 6 months and 12 months | |
Secondary | 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) |
3 months and 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06100107 -
Mirror Therapy in Complex Regional Pain Syndrome Type I
|
N/A | |
Terminated |
NCT00006289 -
Neurotropin to Treat Chronic Neuropathic Pain
|
Phase 2 | |
Terminated |
NCT03309774 -
Complex Regional Pain Syndrome in Children: Impact of Bergès Relaxation on the Autonomic Balance
|
N/A | |
Completed |
NCT00625976 -
Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)
|
N/A | |
Not yet recruiting |
NCT06302920 -
Effect of Kinesiotaping on Pain,Edema and Kinesiophobia in Patients With Complex Regional Pain Syndrome
|
N/A | |
Recruiting |
NCT04703647 -
Longitudinal Follow-up Study About Complex Regional Pain Syndrome (CRPS) Patients
|
||
Completed |
NCT03377504 -
Clinical Evaluation of the Effects of Mirror Therapy in Patients With Complex Regional Pain Syndrome (CRPS) Type 1
|
N/A | |
Recruiting |
NCT06306157 -
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
|
Phase 4 | |
Recruiting |
NCT05745025 -
rTMS and Rehabilitation for Individuals With CRPS Type 1
|
N/A | |
Terminated |
NCT04667364 -
Pain in Complex Regional Pain Syndrome
|
N/A |