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L'essai clinique NCT07091123 pour Persistent Spinal Pain Syndrome est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
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L'essai clinique NCT07091123 est conçu pour étudier le treatment de Persistent Spinal Pain Syndrome. Il s'agit d'un essai interventionnel en Phase IV. Son statut actuel est : en recrutement. L'essai a débuté le 13 octobre 2025 et vise à recruter 36 participants. Dirigé par University Hospitals Cleveland Medical Center, l'essai devrait être terminé d'ici le 11 août 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 15 octobre 2025.
Résumé succinct
Spinal cord stimulation (SCS) or intrathecal drug delivery (pain pump) can be effective in providing pain relief for patients with low back pain who have not responded to other treatments. While both treatments, SCS and pain pump, may help with low back pain relief, it is not known which treatment may work better for patients. SCS and pain pumps involve an implanted device in the body.
In this study, we are asking patients to undergo a trial of both treatment modalities, SCS and pain pump, as screening tests prior to considering an implant. A total of 36 patients will be enrolled in this study. After both trials are completed, participants will be seen in the office and asked which treatment modality they believe has been more effective for relieving pain during the trial periods by completing questionnaires. If neither treatment was effective in improving baseline pain by at least 50%, participants would not qualify for either implant whether or not they are part of this study. Direct study participation would end here. If either or both treatment modalities improved baseline pain by at least 50%, participants will be asked to choose the treatment that worked better: SCS or pain pump. Participants will then have the option to proceed to the permanent implant of choice: SCS or pain pump. Direct study participation would end here but participants will then be followed in the doctor's office after implant as is customary for usual clinical care. The study data collection will conclude when the screening tests are completed.
Titre officiel
Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
Conditions
Persistent Spinal Pain SyndromeAutres identifiants de l'essai
- STUDY20241226
Numéro NCT
Date de début (réel)
2025-10-13
Dernière mise à jour publiée
2025-10-15
Date de fin (estimée)
2027-08-11
Inscription (estimée)
36
Type d'essai
Interventionnel
PHASE
Phase IV
Statut
En recrutement
Mots clés
Pain pump
neuromodulation prognostic tests
neuromodulation prognostic tests
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Croisé
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifGroup A SCS prognostic test performed first followed about 2-4 weeks later with continuous IDD test with bupivacaine 0.625 mg/ml and fentanyl 2 mcg/ml for 8-23 hours. | Pain Pump Spinal catheter place under local anesthesia. Bupivacain 0.625%/Fentanyl 2mcg/ML A solution containing fentanyl 2 mcg/mL and bupivacaine 0.625 mg/mL at an infusion rate of 0.5 ml/hr. Spinal Cord Stimulator (SCS) Two spinal cord stimulation leads will then be advanced under fluoroscopy to the target area, typically around T7-T9 in the posterior epidural space.
Currently, there are six manufacturers of spinal cord stimulation devices with implanted programmable generators or receivers. |
Comparateur actifGroup B IDD prognostic test for 8-23 hours followed 2-4 weeks later by SCS prognostic test. | Pain Pump Spinal catheter place under local anesthesia. Bupivacain 0.625%/Fentanyl 2mcg/ML A solution containing fentanyl 2 mcg/mL and bupivacaine 0.625 mg/mL at an infusion rate of 0.5 ml/hr. Spinal Cord Stimulator (SCS) Two spinal cord stimulation leads will then be advanced under fluoroscopy to the target area, typically around T7-T9 in the posterior epidural space.
Currently, there are six manufacturers of spinal cord stimulation devices with implanted programmable generators or receivers. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in pain intensity as measured by Numerical Rating Scale [NRS] | Numerical Rating Scale \[NRS\] is a numbered scale, from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable | Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group) 3, 6, 12 months for implanted patients |
Change in pain intensity as measured by Oswestry disability index [ODI] | Oswestry disability index \[ODI\] is a questionnaire used to assess the impact of low back pain on a person's daily life. The ODI score ranges from 0 to 100, with lower scores indicating less disability. | Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients |
Change in pain intensity as measured by painDETECT | painDETECT is a nine-item questionnaire. A total score of 19 or more is indicative of likely neuropathic pain. | Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in Patient's Global Impression of Change (PGIC) Scale | Patient's Global Impression of Change (PGIC) Scalr. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." | Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients |
Number of adverse events as measured by patient report, | Up to 12 months | |
Change in daily opioid consumption as measured by Rx report | 3, 6, 12 months |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
30 Years
Sexes éligibles
Tous
- Age 30 years or greater
- Previous lumbar or thoracic spine surgery
- Intractable pain of trunk (more than limbs; ≥ 75%/25% ratio back/leg pain)
- Patient who passed psychological evaluations as part of the usual clinical care prior to consideration of IDDS and are stable with current pain condition and medications
- Failed more conservative management, including physical therapy, medications and injections.
- Untreated infection or coagulopathy/patient unable to stop anticoagulants
- Immune compromised state precluding having an implant
- Allergic reactions to bupivacaine or fentanyl
- Pregnancy.
- Patients using > 15 mg oral equivalents of morphine daily or who are unable to wean down below that dosage for 4 weeks or more before the prognostic test date
- Neurological deficits characterized as weakness in lower extremities with evidence of nerve damage resulting in difficulty ambulating
- Patients deemed by Spine Surgery to be candidates for revision lumbar spine surgery
University Hospitals Cleveland Medical CenterPartie responsable de l'essai
Salim M Hayek, Investigateur principal, Chief of the Division of Pain Medicine at University Hospitals, University Hospitals Cleveland Medical Center
Contact central de l'essai
Contact: Ayse Ulucay, MD, 216-844-3771, [email protected]
1 Centres de l'essai dans 1 pays
Ohio
University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States
En recrutement