Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Nitrous Oxide in Treating Neuropathic Pain: A Study in Chronic Low Back Pain Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alparslan Turan, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01172600
First received: July 27, 2010
Last updated: March 4, 2014
Last verified: March 2014

July 27, 2010
March 4, 2014
July 2010
March 2014   (final data collection date for primary outcome measure)
  • Pain relief [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]
    Pain relief on Visual Analog Scale (VAS), beginning one month after the procedure defined as a difference of 15 mm or less.
  • Pain Relief [ Time Frame: 3 mos. post treatment ] [ Designated as safety issue: No ]
    Pain relief on Visual Analog Scale (VAS), beginning one month after the procedure defined as a difference of 15 mm or less.
  • Pain Relief [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]
    Pain relief on Visual Analog Scale (VAS), beginning one month after the procedure defined as a difference of 15 mm or less.
Same as current
Complete list of historical versions of study NCT01172600 on ClinicalTrials.gov Archive Site
  • Functional capacity [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]
    Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.
  • Functional Capacity [ Time Frame: 3 most post treatment ] [ Designated as safety issue: No ]
    Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.
  • Functional Capacity [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]
    Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.
  • Opioid intake reduction [ Time Frame: 3 mos. post treatment ] [ Designated as safety issue: No ]
    Reduction in opioid intake at 3, 6, and 12 months post treatment
  • Opioid intake reduction [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]
    Reduction in opioid intake at 3, 6, and 12 months post treatment
  • Opioid intake reduction [ Time Frame: 12 mos. post treatment ] [ Designated as safety issue: No ]
    Reduction in opioid intake at 3, 6, and 12 months post treatment
  • biomarkers [ Time Frame: baseline, pre treatment ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
  • Biomarkers [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
  • Biomarkers [ Time Frame: 3 mos. post treatment ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
  • Biomarkers [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
  • Functional capacity [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]
    Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.
  • Functional Capacity [ Time Frame: 3 most post treatment ] [ Designated as safety issue: No ]
    Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.
  • Functional Capacity [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]
    Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.
  • Opiod intake reduction [ Time Frame: 3 mos. post treatment ] [ Designated as safety issue: No ]
    Reduction in opioid intake at 3, 6, and 12 months post treatment
  • opiod intake reduction [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]
    Reduction in opioid intake at 3, 6, and 12 months post treatment
  • opiod intake reduction [ Time Frame: 12 mos. post treatment ] [ Designated as safety issue: No ]
    Reduction in opioid intake at 3, 6, and 12 months post treatment
  • biomarkers [ Time Frame: baseline, pre treatment ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
  • Biomarkers [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
  • Biomarkers [ Time Frame: 3 mos. post treatment ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
  • Biomarkers [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
Not Provided
Not Provided
 
Effect of Nitrous Oxide in Treating Neuropathic Pain: A Study in Chronic Low Back Pain Patients
Effect of Nitrous Oxide in Treating Neuropathic Pain: A Pilot 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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
  • Low Back Pain
  • Radiating Pain
  • Other: Entonox
    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.
    Other Name: Nitrous Oxide
  • Other: Oxygen
    Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery.
  • Active Comparator: Entonox
    Patients will receive inhaled Entonox along with the interventional block they are scheduled.
    Intervention: Other: Entonox
  • Placebo Comparator: Oxygen
    Patients will receive inhaled oxygen along with the interventional block they are scheduled.
    Intervention: Other: Oxygen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 to 80 years old at time of the first procedure
  • Male or female
  • History of chronic low back pain for longer than 6 months due to radiculopathy, symptomatic spinal canal stenosis, disc prolapse, postlaminectomy syndrome
  • magnetic resonance imaging or electromyographic evidence of nerve root damage
  • Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score of >12
  • No or minimal evidence of facet joint pathology

Exclusion Criteria:

  • Known contraindications for epidural injection
  • Patients with ongoing workers' compensation claims
  • unstable or heavy opioid use (400 mg of morphine equivalents daily),
  • psychiatric disorders
  • medical illness, including conditions that could interfere with the interpretation of the outcome assessments
  • pregnant or lactating women
  • Current or recent drug abuse (within past 6 months).
  • Patient refuses regional analgesia.
  • Alcohol or drug abuse
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01172600
10-446
No
Alparslan Turan, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Alparslan Turan, M.D. The Cleveland Clinic
The Cleveland Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP