Syringe Pressure Analysis: A Critical Examination of the Operator's Burden
CompletedNot applicableNCT06476353
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This was a randomized prospective clinical trial conducted from October 1, 2023, to May 15, 2024, at the University Surgery Center in Merced, CA. The project was approved by the MetroWest Medical Center Institutional Review Board (IRB). Patients in each procedure group were categorized into groups and randomly distributed into four sub-groups based on the syringe size used (5ml, 10ml, 20ml, 30ml). A medical grade force sensor device was used to collect the necessary real-time syringe force data. An analysis of variance (ANOVA), and pairwise t test were used to make comparisons between means and determine statistical significance.
Study details
- Official title
- Comparative Analysis of Force and Pressure Requirements Across Different Syringe Sizes for Pain Management Procedures: A Randomized Prospective in Vivo Trial
- Conditions
- Interventions
- Other: Analysis of Force and Pressure Requirements across Syringe Sizes for Pain Management Procedures
- Sponsor
- Orthospine Advance Health, Inc.
- Start date
- 2023-10-01
- Primary completion
- 2024-05-15
- Sex
- All
- Age range
- from 19 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adult patients 19 years old and older, no convicts, no prior history of infection, cancer, or contraindications for surgical procedures. * Patients scheduled for pain injections who agree to participate in the study, sign the informed consent, IRB approval consent, and agree to answer preoperative, postoperative, and 1-week postoperative questionnaires. * Patients with chronic lower back pain for over three months, not responding to conventional treatment, including NSAID drugs, core back muscle strengthening with lower back exercises or physiotherapy. * Symptoms suggestive of facet pain (e.g., LBP with or without radiation to the buttocks, thigh, or groin; pain increasing on hyperextension; pain when initiating movement) scheduled for medial branch blocks and radiofrequency injections when indicated, with focal tenderness over the facet joint elicited by digital pressure. * Post-lumbar disc surgery patients with persistent pain and no MRI evidence of arachnoiditis or infection. * For all pain procedures, fluoroscopic guidance will be utilized for spinal needle placements. * Data collection will include gender, race, height, weight, BMI, radiation exposure from the fluoroscopy dosage logbook, procedure time, horizontal distance measurement between the same spinal level in centimeters (interspinous-same spinal level), and longitudinal distance measurement from needles (adjacent spinal level). * The study period is from October 1, 2023, to May 15, 2024. Exclusion Criteria: * Clinical or imaging evidence of infection (elevated WBC 12000 or UTI) or neoplastic disease. * Possible pregnancy, bleeding diathesis, or anticoagulant therapy. * History of sensitivity to local anesthetics. * Potential Failures: if we encounter any technical failure or unreliable no readings with the equipment obtaining the injection peak force curve, will exclude those readings (NA). Data Collection for Both Cohort Groups: \- Gender, age, height (inches), weight (kg), BMI, time from the start of the procedure until the end of needle placement.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06476353