Low Back PainNCT01172600

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

A study testing Entonox and Oxygen in people with Low Back Pain and Radiating Pain, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Low Back Pain, Radiating Pain
What is being tested?: Entonox and Oxygen
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 78 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Mar 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

Current or recent drug abuse (within past 6 months).
Patient refuses regional analgesia.
Alcohol or drug abuse

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Foundation
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: 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.

Conditions: Low Back Pain, Radiating Pain
Being tested: Entonox, Oxygen
Keywords: radiating back pain, epidural block, steroid, recurrent low back pain, Lumbar Epidural Steroid Block with 3 injections
Medical subject headings: Low Back Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EntonoxOther
Also called Nitrous Oxide
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.
OxygenOther
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.

Study groups in NCT01172600
Study group	Role	What they receive
Entonox	Active comparator	Patients will receive inhaled Entonox along with the interventional block they are scheduled. Receives: Other: Entonox
Oxygen	Placebo comparator	Patients will receive inhaled oxygen along with the interventional block they are scheduled. Receives: Other: Oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline
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
Measured: At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline

Secondary outcomes (10)

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.
Measured: At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline
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.
Measured: At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline
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.
Measured: 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)
Usage of Opioids
Measured: 2nd block, typically at 1 month from baseline
Usage of Opioid
Measured: 3rd block, typically at 2 months from baseline
Usage of Opioid
Measured: 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)
Biomarkers
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Measured: baseline - before 1st block
Biomarkers
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Measured: before 2nd block, typically at 1 month from baseline
Biomarkers
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Measured: before 3rd block, typically at 2 months from baseline
Biomarkers
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Measured: 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Mar 2013

First posted30 Jul 2010 (estimated)
Study startJan 2011
Primary completionJan 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Low Back PainStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01172600
Sponsor's protocol ID: 10-446
Status last verified: Aug 2016
First submitted: 27 Jul 2010
Last updated: 17 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Nitrous Oxide in Treating Neuropathic Pain: A Pilot Study in Chronic Low Back Pain Patients
ClinicalTrials.gov ID: NCT01172600
Acronym / sponsor ID: 10-446
Conditions: Low Back Pain, Radiating Pain
Keywords: radiating back pain, epidural block, steroid, recurrent low back pain, Lumbar Epidural Steroid Block with 3 injections
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: Jan 2011
Primary completion: Jan 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 30 Jul 2010 (estimated)
Results: Posted 17 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Entonox	Active comparator	Other: EntonoxPatients will receive inhaled Entonox along with the interventional block they are scheduled.
Oxygen	Placebo comparator	Other: OxygenPatients will receive inhaled oxygen along with the interventional block they are scheduled.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EntonoxAlso: Nitrous OxideThose 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	Entonox
OxygenThose 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.	Other	Oxygen

Primary outcome

Change in VAS Pain Score From Baseline to 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)
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
Time frame: At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline
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
Time frame: At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline
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

10 secondary outcomes

Change in Oswestry Score (% of Disability) From Baseline to 2nd Block
Time frame: At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline
Change in Oswestry Score (% of Disability) From Baseline to 3rd Block
Time frame: At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline
Change in Oswestry Score (% of Disability) From Baseline 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)
Usage of Opioids
Time frame: 2nd block, typically at 1 month from baseline
Usage of Opioid
Time frame: 3rd block, typically at 2 months from baseline
Usage of Opioid
Time frame: 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)
Biomarkers
Time frame: baseline - before 1st block
Biomarkers
Time frame: before 2nd block, typically at 1 month from baseline
Biomarkers
Time frame: before 3rd block, typically at 2 months from baseline
Biomarkers
Time frame: 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)

Results and safety

Results posted to the registry on 17 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Entonox	39	39
Oxygen	39	39

Primary outcome: Change in VAS Pain Score From Baseline to 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). Mean (Standard Deviation). Unit: units on a scale

Measure	Entonox n = 39	Oxygen n = 39
Value	-1.6 (3.0)	-1.2 (2.6)

Entonox vs Oxygen: Mean Difference (Final Values): -0.13 (95% CI -1.43 to 1.17), p = 0.84, Regression, Linear
Entonox vs Oxygen: Mean Difference (Final Values): -1.03 (95% CI -2.34 to 0.28), p = 0.12, Regression, Linear

Population analysed: For 10 patients with missing VAS at 3 month follow up: 5 patients who had 2nd or 3rd epidural block, we assigned the last VAS observation (i.e., from VAS before 2nd or 3rd block to 3 month follow-up); and for 5 patients who only had 1st epidural, we assigned the worst VAS (10) for Entonox patients and the best VAS (0) for Oxygen patients.

Primary outcome: Change in VAS Pain Score From Baseline to Before 2nd Block

Time frame: At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Entonox n = 29	Oxygen n = 28
Value	-0.6 (1.7)	-0.4 (2.1)

Entonox vs Oxygen: Mean Difference (Final Values): -0.29 (98.3% CI -1.80 to 1.21), p = 0.63, Mixed Models Analysis

Population analysed: 10 patients in the Entonox group and 11 patients in the Oxygen group did not receive the 2nd block treatment

Primary outcome: Change in VAS Pain Score From Baseline to Before 3rd Block

Time frame: At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Entonox n = 18	Oxygen n = 13
Value	-2.1 (3.0)	-0.5 (2.2)

Entonox vs Oxygen: Mean Difference (Final Values): -1.11 (98.3% CI -3.05 to 0.82), p = 0.16, Mixed Models Analysis

Population analysed: 21 patients in the Entonox group and 26 patients in the Oxygen group did not receive the 2nd block treatment

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Entonox	0 of 39 (0%)	0 of 39 (0%)	Not reported
Oxygen	0 of 39 (0%)	0 of 39 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Low Back Pain

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alparslan Turan, M.D. principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Entonox and Oxygen in people with Low Back Pain and Radiating Pain, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in VAS Pain Score From Baseline to 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01172600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.