Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.

Обзор

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.

Вмешательства

• Устройство Pain pump
  Spinal catheter place under local anesthesia.
• Препарат 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.
• Устройство 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.

Первичные конечные точки

• Change in pain intensity as measured by Numerical Rating Scale [NRS] [Срок оценки: 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] [Срок оценки: 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 [Срок оценки: 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]

Вторичные конечные точки (3)

• Change in quality of life as measured by the PROMIS-29. [Срок оценки: 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, [Срок оценки: Up to 12 months]
• Change in daily opioid consumption as measured by Rx report [Срок оценки: 3, 6, 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University Hospitals Cleveland Medical Center — Cleveland

Идентификаторы

NCT: NCT07091123 · STUDY20241226

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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