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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01172600
• Other study ID #: 10-446
• Status: Active, not recruiting
• Phase: N/A
• First received: July 27, 2010
• Last updated: August 7, 2015
• Start date: July 2010
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Neuralgia
• Radiating Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Pain relief on Visual Analog Scale (VAS), beginning one month after the procedure defined as a difference of 15 mm or less.	30 days post treatment	No
Primary	Pain Relief	Pain relief on Visual Analog Scale (VAS), beginning one month after the procedure defined as a difference of 15 mm or less.	3 mos. post treatment	No
Primary	Pain Relief	Pain relief on Visual Analog Scale (VAS), beginning one month after the procedure defined as a difference of 15 mm or less.	6 mos. post treatment	No
Secondary	Functional capacity	Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.	30 days post treatment	No
Secondary	Functional Capacity	Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.	3 most post treatment	No
Secondary	Functional Capacity	Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.	6 mos. post treatment	No
Secondary	Opioid intake reduction	Reduction in opioid intake at 3, 6, and 12 months post treatment	3 mos. post treatment	No
Secondary	Opioid intake reduction	Reduction in opioid intake at 3, 6, and 12 months post treatment	6 mos. post treatment	No
Secondary	Opioid intake reduction	Reduction in opioid intake at 3, 6, and 12 months post treatment	12 mos. post treatment	No
Secondary	biomarkers	BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment	baseline, pre treatment	No
Secondary	Biomarkers	BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment	30 days post treatment	No
Secondary	Biomarkers	BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment	3 mos. post treatment	No
Secondary	Biomarkers	BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment	6 mos. post treatment	No