Clinical Trials Logo

Clinical Trial Summary

Epidural injection will be completed under fluoroscopy and all patients will receive 1-4 mg of Midazolam for relaxation before procedure and, if needed, 50-100 mcg of Fentanyl intravenous (IV). Radiopaque contrast (Omnipaque 300), for confirming the epidural position of the needle, steroids and local anesthetic agents will be used according to the physician performing the block and will not be controlled by the study. Patients will be randomly assigned to receive either inhaled Entonox along with the interventional block they are scheduled for or oxygen. They will be blinded about the treatment they are receiving. Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery. Those randomized to the oxygen group will receive oxygen through a similar mouthpiece for the entire duration of the procedure and recovery for 4 hours. Following completion of procedure the patient will be transferred to recovery and monitored for 3-5 hours then discharged home with instructions. Possible side effects will be monitored and recorded, pain score of patient will be recorded before discharge. All the patients will receive standard instructions regarding physical back exercises. This will be repeated for every procedure up to maximum of three blocks.

The patients will be followed during each block and over a period of 1, 3, 6 and 12 months and on each follow-up visit will complete computerized set of questionnaires as they did before the procedure. The patients charts will be then reviewed for one year after the initial procedure to determine if further epidural steroid injections or surgery for the presenting problem were required. It is anticipated that the appropriate number of patients will be enrolled within six months of study initiation.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01172600
Study type Interventional
Source The Cleveland Clinic
Contact
Status Active, not recruiting
Phase N/A
Start date July 2010
Completion date June 2016

See also
  Status Clinical Trial Phase
Completed NCT03916705 - Thoraco-Lumbar Fascia Mobility N/A
Completed NCT04007302 - Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03600207 - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain N/A
Completed NCT04284982 - Periodized Resistance Training for Persistent Non-specific Low Back Pain N/A
Recruiting NCT05600543 - Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain N/A
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Completed NCT03673436 - Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Completed NCT02546466 - Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain N/A
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05156242 - Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain. N/A
Recruiting NCT04673773 - MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain. N/A
Completed NCT06049277 - Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain N/A
Completed NCT06049251 - ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises N/A
Completed NCT04980469 - A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle N/A
Completed NCT04055545 - High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects N/A
Recruiting NCT05944354 - Wearable Spine Health System for Military Readiness
Recruiting NCT05552248 - Assessment of the Safety and Performance of a Lumbar Belt
Completed NCT05801588 - Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life N/A
Completed NCT05811143 - Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.