Chronic Low Back Pain Clinical Trial
Official title:
A Randomized Double Blind Cross-over Trial of Continuous Intrathecal Infusion for Assessing Patients With Chronic Non-cancer Pain Who Would Benefit From Treatment With Intrathecal Drug Delivery System (IDDS) Implant
Verified date | December 2022 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study will be to determine the efficacy and the prognostic value of a continuous intrathecal prognostic infusion test in an in-hospital setting for selecting patients who would have better long term outcomes for treatment with intrathecal implantable devices. The investigators will compare the primary outcomes [changes in pain intensity score (NRS), patient global impression of change (PGIC)] before and after intrathecal infusion of an admixture of bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml versus normal saline. The study will include 36 patients with intractable chronic low back pain in the setting of lumbar post-laminectomy syndrome or vertebral compression fracture who failed conservative management and are considered candidates for IDDS. Prior to the implant, the patients will undergo an intrathecal prognostic infusion test with an externalized catheter. Baseline NRS pain scores will be assessed and documented on all patients upon admission to the preoperative area. An intrathecal catheter will be placed in the outpatient procedure suite at the appropriate level for target dermatomes. The needle entry point will occur in the upper lumbar spine and catheter tip will be placed in the lower thoracic spine, under local anesthesia with the patient awake and with minimal or no sedation. The intrathecal infusion will be started using an external pump once patient is in the PACU. The research component is to perform the intrathecal test with normal saline (inactive placebo solution) in addition to a test with fentanyl and bupivacaine (active solution). Patients will be randomly assigned to either Group I (continuous infusion of bupivacaine and fentanyl followed by saline) or Group II (continuous infusion of saline followed by bupivacaine and fentanyl). In PACU, patients will be started on an infusion rate of 0.5 ml/hr and titrated to pain relief greater than 50% of baseline or up to 0.8-1.0 ml/hr within 6-8 hrs after start of the infusion. A clinician blinded to the treatment arm will assess NRS and PGIC on the patients after approximately 12 hours. Assessment will include changes in pain intensity score at rest and upon ambulating or performing maneuvers that normally elicit patient's low back pain. A 4-6-hour washout period will be allotted with infusion of preservative-free normal saline at a rate of 0.2 ml/hr, after which the physician will document a return of the NRS to baseline before switching therapies.
Status | Completed |
Enrollment | 36 |
Est. completion date | October 12, 2021 |
Est. primary completion date | October 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: - Previous lumbar or thoracic spine surgery or lower thoracic/lumbar vertebral compression fracture - Intractable pain of trunk (more than limbs) - 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. Exclusion Criteria: - Untreated coagulopathy or infection. - Immune compromised state precluding having an implant. - Allergic reactions to bupivacaine or fentanyl. - Pregnancy - Patients using more than 30 mg oral equivalents of morphine daily or who are unable to wean down below that dosage for more than 4 weeks before the prognostic intrathecal infusion test. - Neurological deficits characterized as weakness in lower extremities with evidence of nerve damage - Patients with cognitive disorders who would not be able to provide meaningful outcome responses |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center |
United States,
Deer TR, Prager J, Levy R, Burton A, Buchser E, Caraway D, Cousins M, De Andres J, Diwan S, Erdek M, Grigsby E, Huntoon M, Jacobs M, Kim P, Kumar K, Leong M, Liem L, McDowell G, Panchal SJ, Rauck R, Saulino M, Staats P, Stanton-Hicks M, Stearns L, Sitzman BT, Wallace M, Willis KD, Witt W, Yaksh T, Mekhail N. Polyanalgesic Consensus Conference--2012: recommendations on trialing for intrathecal (intraspinal) drug delivery: report of an interdisciplinary expert panel. Neuromodulation. 2012 Sep-Oct;15(5):420-35; discussion 435. doi: 10.1111/j.1525-1403.2012.00450.x. Epub 2012 Apr 11. — View Citation
Deer TR, Prager J, Levy R, Rathmell J, Buchser E, Burton A, Caraway D, Cousins M, De Andres J, Diwan S, Erdek M, Grigsby E, Huntoon M, Jacobs MS, Kim P, Kumar K, Leong M, Liem L, McDowell GC 2nd, Panchal S, Rauck R, Saulino M, Sitzman BT, Staats P, Stanton-Hicks M, Stearns L, Wallace M, Willis KD, Witt W, Yaksh T, Mekhail N. Polyanalgesic Consensus Conference 2012: recommendations for the management of pain by intrathecal (intraspinal) drug delivery: report of an interdisciplinary expert panel. Neuromodulation. 2012 Sep-Oct;15(5):436-64; discussion 464-6. doi: 10.1111/j.1525-1403.2012.00476.x. Epub 2012 Jul 2. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Numerical Rating Scale Pain Scores (NRS) With Activity | Numerical Rating Scale is an 11-point pain scale whereby 0 signifies no pain and 10 the worse pain ever | Comparing change in NRS from baseline (Day 1) to: end of intrathecal infusion of solution 1 (Day 2), end of intrathecal infusion of solution 2 (Day 3) | |
Primary | Change in Numerical Rating Scale Pain Scores (NRS) at Rest | Numerical Rating Scale is an 11-point pain scale whereby 0 signifies no pain and 10 the worse pain ever | Comparing change in NRS from baseline (Day 1) to: end of intrathecal infusion of solution 1 (Day 2), end of intrathecal infusion of solution 2 (Day 3) | |
Secondary | Change in Oswestry Disability Score (ODI) | Oswestry Disability Index (ODI) This scale based on a questionnaire of activities measures the impact of pain on multiple factors within a patient's daily life. Higher values represent worse outcomes, or a higher impact from pain on the patient's daily life. The total score range is 0-50. Subcategories include: 0-4: no disability. 5-14: mild disability. 15-24: moderate disability. 25-34: sever disability. 35-50: completely disabled. | Comparing change in ODI from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3) | |
Secondary | Change in painDETECT Total | The painDETECT questionnaire was specifically developed to detect neuropathic pain components in adult patients with low back pain. PainDETECT is a scale of 0 to 35, with 0 being no disability to 35 being max disability. | Comparing change in PainDETECT from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3) | |
Secondary | Change in painDETECT Final | The painDETECT questionnaire was specifically developed to detect neuropathic pain components in adult patients with low back pain. PainDETECT is a scale 0 to 38, with 0 being no disability to 38 being max disability. | Comparing change in PainDETECT from baseline (Day 1) to: end of intrathecal infusion of solution 2 (Day 3) | |
Secondary | Change in Patient Global Impression of Change (PGIC) | Patient Global Impression of Change (PGIC) scale is a seven-point single-item scale ranging from 7 'very much worse' to 1 'very much improved'. | Comparing change in PGIC from end of intrathecal infusion of solution 1 (Day 2), to end of intrathecal infusion of solution 2 (Day 3) | |
Secondary | Treatment Satisfaction Questionnaire (TSQ) | TSQ is a questionnaire to rate level of satisfaction or dissatisfaction with the Intrathecal Drug Delivery- patients were asked preference for either intrathecal solution. Patient preferences for each solution were measured. This data represents the total number of patient's that received a trial and the total number of patients who preferred each solution. Higher values indicate a greater number of study participants preferred a specific arm. Patients with no preference are listed separately. | Up to one year | |
Secondary | Adverse Event (AE) | AE is any untoward medical occurrence in the patient which does not necessarily have a causal relationship with this infusion treatment | Assessing any AEs that occur from baseline (Day 1) through the 12-month post-implant clinic follow up | |
Secondary | Change in Medication | Number of participants that had increases or decreases in the dose or frequency of pain medication | Assessing any changes in pain medications from baseline (Day 1) through the 12-month post-implant clinic follow up |
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