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NCT01172600 · ClinicalTrials.gov registry record · NA
Effect of Nitrous Oxide in Treating Neuropathic Pain: A Study in Chronic Low Back Pain Patients
A NA study of Low Back Pain and Radiating Pain, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT01172600: Completed NA study of Low Back Pain and Radiating Pain, sponsored by The Cleveland Clinic.
NCT01172600 is a NA study of Low Back Pain and Radiating Pain that has completed, run by The Cleveland Clinic. The registered enrollment target is 78 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01172600, a NA study of Low Back Pain and Radiating Pain, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up. The primary outcome was the change in VAS pain score from baseline (before 1st block) to the 3 month follow-up.
Conditions Studied
Interventions
- OTHER Oxygen
- OTHER Entonox
Study Locations (1)
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-03 |
| Phase | NA |
What the finished NCT01172600 record still lists
NCT01172600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Oxygen is the first listed.
NCT01172600 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01172600 about?
NCT01172600 is a clinical study titled "Effect of Nitrous Oxide in Treating Neuropathic Pain: A Study in Chronic Low Back Pain Patients". 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 loca...
What is the current status of trial NCT01172600?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2011-01. Estimated completion is 2013-03.
What conditions does trial NCT01172600 study?
This clinical trial studies the following conditions: Low Back Pain, Radiating Pain.
What interventions are being tested in trial NCT01172600?
The interventions under investigation include: Oxygen (OTHER), Entonox (OTHER).
Who is sponsoring clinical trial NCT01172600?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01172600 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01172600's enrollment target sits among peer trials
78 68th of 122 higher than 55 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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