Success Rates and Safety in Managing Spinal and Sacro-Iliac Pain: A Critical Analysis
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Integral of pain relief
Study Overview
Brief Summary
This study aims to analyze the efficacy and safety of different kinds of steroid injections for back pain, comparing different steroids, dosages, locations (epidural, facet joints, nerve blocks), and also the difference between injections with steroids and local anesthetics, to optimize this treatment that is currently not standardized. The investigators will compare retrospectively and prospectively the efficacy of different injections in the same patients, using mainly a parameter called integral of pain relief, which combines the percentage of pain relief provided by a treatment and its duration over time, as well as improvements in functionality.
Detailed Description
This single-centre study will consist of two parts, one retrospective and one prospective with cross-over design, to analyze and summarize the investigators' experience in the evaluation of:
- Efficacy of ultrasonography (US)-guided epidural steroid injections (caudal and interlaminar, compared to transforaminal if performed elsewhere and data available) in patients with lumbar-sacral pain for central spinal stenosis, neuroforaminal stenosis, herniated disc, or failed back surgery syndrome (FBSS);
- Efficacy of cervical, thoracic, and lumbar facet joint and sacroiliac joints (SIJ) injections in patients with nociceptive spinal pain (e.g., osteoarthritis [OA]);
- Spinal levels most frequently affected;
- How frequently a pain presenting as sciatica is actually due instead to hip OA, trochanter pain, bursitis, or SIJ pain, rather than spine pathology.
In this study, the investigators will include at least 100 patients per part with lumbar spinal pain due to lumbar canal stenosis, herniated discs or FBSS (lumbar radiculopathy), treated with caudal or interlaminar epidural steroid injections through different protocols, all under US guidance. In addition, the investigators will examine different administration protocols, including the following injections: facet joints (100 each for cervical and lumbar pain, and as many as possible for thoracic) and/or SIJ (100), compared with injections of local anesthetics only, with Marcaine or Sensorcaine (bupivacaine) or Xylocaine (lidocaine), or oral low-dose naltrexone (spinal radiculopathy).
Comparing these interventions through rigorous research, the study may provide healthcare professionals with refined treatment guidelines, optimized patient care pathways, and ultimately improve outcomes and quality of life for individuals living with chronic back pain. This research could benefit current patients and contribute to the broader knowledge in pain management, guiding future advancements in the field.
The primary objectives of this study are to determine:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>18 years of age;
- •Diagnosis of lumbar, cervical, or thoracic pain with various etiologies;
- •Eligibility to receive steroid injections for back pain, including epidural, facet joints, or SIJ injections, or other injections (e.g., local anesthetics);
- •Being willing and able to provide NRS pain ratings and PROMIS functionality ratings before the intervention, and the same scores plus IPR, fIPR, and PGIC at various follow-up points after the intervention;
- •Provide written informed consent.
Exclusion Criteria
- •Diagnosis of dementia, Parkinson's disease or other cognitive impairments;
- •Congenital or acquired polyneuropathy;
- •Back surgery in the month before injection treatment or planned surgery in the subsequent 3 months;
- •Any clinically significant acute or chronic medical condition that in the judgment of Investigator may preclude injection in the epidural space or compromise patient safety, limit patient's ability to complete the study, and/or compromise the objectives of the study;
- •Participation in any other competing clinical study within 3 months prior to screening and during the study period.
Arms & Interventions
Spinal steroid injections with triamcinolone
Intervention: triamcinolone acetonide (Kenalog) (Drug)
Spinal steroid injections with methylprednisolone
Intervention: Depo-Medrol 40Mg/Ml Suspension for Injection (Drug)
Spinal steroid injections with betamethasone
Intervention: Celestone Soluspan 6Mg/Ml Suspension for Injection (Drug)
Spinal steroid injections with dexamethasone
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Integral of pain relief
Time Frame: 8-12 weeks, up to 6 months or one year if applicable
parameter obtained by multiplying the percentage of pain relief provided by a treatment by the number of days of relief
Numeric rating scale
Time Frame: 2, 4, 6, 8, 12 weeks
Scale from 0 to 10 assessing the pain intensity
Functional integral of pain relief
Time Frame: 8-12 weeks, up to 6 months or one year if applicable
Percentage of functionality improvements multiplied by the number of days of improvement duration
Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire - custom version
Time Frame: 2, 4, 6, 8, 12 weeks
Customized PROMIS questionnaire to assess the overall functional status: 12 questions, each with scores variable between 5 (no difficulty or best possible situation, depending on the question ) and 1 (unable to do or worst case scenario). Four questions relate to physical function, two to fatigue, one to sleep quality, two to mood, two to social roles and activity, and one to pain interference with general activities. The maximum score (no problem) is 60, and the minimum is 12 (severely incapacitated).
Patient's global impression of change (PGIC)
Time Frame: 2, 4, 6, 8, 12 weeks
7-grade scale representing the overall assessment of change perceived by the patient, from Very Much Improved to Very Much Worsened
Secondary Outcomes
No secondary outcomes reported
Investigators
Igor Wilderman. MD
Principal Investigator
Wilderman Medical Clinic