search
Back to results

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

Primary Purpose

Low Back Pain, Radiating Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Entonox
Oxygen
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Back Pain focused on measuring radiating back pain, epidural block, steroid, recurrent low back pain, Lumbar Epidural Steroid Block with 3 injections

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Entonox

Oxygen

Arm Description

Patients will receive inhaled Entonox along with the interventional block they are scheduled.

Patients will receive inhaled oxygen along with the interventional block they are scheduled.

Outcomes

Primary Outcome Measures

Change in VAS Pain Score From Baseline to 3 Month Follow-up
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.
Change in VAS Pain Score From Baseline to Before 2nd Block
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 before the 2nd block.
Change in VAS Pain Score From Baseline to Before 3rd Block
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 before the 3rd block

Secondary Outcome Measures

Change in Oswestry Score (% of Disability) From Baseline to 2nd Block
Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 2nd block.
Change in Oswestry Score (% of Disability) From Baseline to 3rd Block
Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 3rd block.
Change in Oswestry Score (% of Disability) From Baseline to 3 Months Follow-up
Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to 3 months follow-up.
Usage of Opioids
Usage of Opioid
Usage of Opioid
Biomarkers
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Biomarkers
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Biomarkers
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Biomarkers
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α

Full Information

First Posted
July 27, 2010
Last Updated
August 24, 2016
Sponsor
The Cleveland Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT01172600
Brief Title
Effect of Nitrous Oxide in Treating Neuropathic Pain: A Study in Chronic Low Back Pain Patients
Official Title
Effect of Nitrous Oxide in Treating Neuropathic Pain: A Pilot Study in Chronic Low Back Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Radiating Pain
Keywords
radiating back pain, epidural block, steroid, recurrent low back pain, Lumbar Epidural Steroid Block with 3 injections

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Entonox
Arm Type
Active Comparator
Arm Description
Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Arm Title
Oxygen
Arm Type
Placebo Comparator
Arm Description
Patients will receive inhaled oxygen along with the interventional block they are scheduled.
Intervention Type
Other
Intervention Name(s)
Entonox
Other Intervention Name(s)
Nitrous Oxide
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in VAS Pain Score From Baseline to 3 Month Follow-up
Description
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.
Time Frame
At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)
Title
Change in VAS Pain Score From Baseline to Before 2nd Block
Description
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 before the 2nd block.
Time Frame
At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline
Title
Change in VAS Pain Score From Baseline to Before 3rd Block
Description
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 before the 3rd block
Time Frame
At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline
Secondary Outcome Measure Information:
Title
Change in Oswestry Score (% of Disability) From Baseline to 2nd Block
Description
Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 2nd block.
Time Frame
At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline
Title
Change in Oswestry Score (% of Disability) From Baseline to 3rd Block
Description
Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 3rd block.
Time Frame
At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline
Title
Change in Oswestry Score (% of Disability) From Baseline to 3 Months Follow-up
Description
Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to 3 months follow-up.
Time Frame
At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)
Title
Usage of Opioids
Time Frame
2nd block, typically at 1 month from baseline
Title
Usage of Opioid
Time Frame
3rd block, typically at 2 months from baseline
Title
Usage of Opioid
Time Frame
3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)
Title
Biomarkers
Description
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Time Frame
baseline - before 1st block
Title
Biomarkers
Description
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Time Frame
before 2nd block, typically at 1 month from baseline
Title
Biomarkers
Description
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Time Frame
before 3rd block, typically at 2 months from baseline
Title
Biomarkers
Description
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Time Frame
3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alparslan Turan, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs