Epidural Clonidine Versus Corticosteroid for Low Back Pain

• Sponsor: West Virginia University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02239627
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Low back pain is a common condition, affecting majority of the adults in the United States at some point in their lives. Fortunately, most resolve, even without treatment. However, some suffer from continued or recurrent pain.

For those suffering from continued or recurrent low back pain, numerous treatment options exist. One such option is an epidural injection, particularly when other non-surgical treatment options have failed. An epidural injection is the placement of a needle into the space around the spinal cord with the aid of a live X-Ray machine, followed by an injection of various medications. Typically, the medication that is injected is a steroid, commonly with the combination of local anesthetic medication. Epidural steroid injections, with or without local anesthetic is part of the established standard of care in the United States for those with continued or recurrent low back pain. The steroid is believed to reduce inflammation and edema of the injured or irritated nerves. However, despite the routine use of epidural steroids, the steroid itself is not without risks or side effects. Though rare, the steroids have been associated with complications including osteoporosis, steroid induced myopathy, cataracts and many others. In order to minimize the side effects associated with epidural steroids, limiting the dose and frequency have been outlined.

Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and Drug Administration approved the medication for epidural use for cancer pain but studies have shown effectiveness in non-cancer pain was well and is routinely used for various conditions. There is growing evidence on the use of epidural clonidine for treatment of pain, including low back pain.

This research will study and compare the effectiveness, if any, of clonidine compared to steroid in an epidural injection for low back pain.

Condition or Disease	Intervention/Treatment	Phase
Back Pain	Drug: Epidural steroid; Drug: Clonidine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized, Double Blinded Comparison of the Analgesic Efficacy of Epidural Clonidine Versus Corticosteroid for Low Back Pain
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Steroid Epidural steroid injection	Drug: Epidural steroid
Experimental: Clonidine Epidural clonidine injection	Drug: Clonidine

Outcome Measures

Primary Outcome Measures

1. Pain Intensity Measured on Visual Analog Scale (VAS) [3 months]

Secondary Outcome Measures

1. Percentage of Pain Relief [Day 0, 3 weeks, 3 months]

2. Level of Disability (Oswestry Back Scale) [3 weeks, 3 months]

3. Adverse Events [Day 0, 3 weeks, 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Subject has clinical diagnosis of low back due to intervertebral disc disease, spinal stenosis or herniated disc

2. Subject has average pain score (VAS) at least 5

3. Subject has persistent pain despite conservative care

4. Subjects has experienced pain for at least 1 month

5. 18 years of age or older when written informed consent is obtained

6. Signed Institutional Review Board (IRB) approved informed consent form

Exclusion Criteria:

1. Allergy to clonidine, dexamethasone, ropivicaine or lidocaine

2. Coagulopathy

3. Active Infection

4. Serious neurologic deficit

5. Subject is pregnant or planning on becoming pregnant during the course of the study

6. Subject is member of a vulnerable population

7. Investigator suspects substance abuse that might confound the study results

8. Subject has unresolved major issues of secondary gain (as determined by the investigator)

9. Subject exhibits major psychiatric morbidity, untreated or refractory to treatment as determined by the investigator

10. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Virginia University Hospitals	Morgantown	West Virginia	United States	26505

Sponsors and Collaborators

• West Virginia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: West Virginia University
• ClinicalTrials.gov Identifier: NCT02239627
• Other Study ID Numbers: 1407358518
• First Posted: Sep 15, 2014
• Last Update Posted: Jan 20, 2021
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Back Pain; Low Back Pain; Clonidine

Study Results

Participant Flow

Recruitment Details	The study was terminated and the PI has left the institution. The numbers presented are what was initially entered by the research team. From data available, 16 participants were enrolled on the study; no information about those participants could be located. No other data could be located and it cannot be determined which arm the16 participants were enrolled in or if they completed the study.

Arm/Group Title	Steroid	Clonidine
Arm/Group Description	Epidural steroid injection Epidural steroid	Epidural clonidine injection Clonidine
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Steroid	Clonidine	Total
Arm/Group Description	Epidural steroid injection Epidural steroid	Epidural clonidine injection Clonidine	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Race and Ethnicity Not Collected () []

Outcome Measures

1. Primary Outcome

Title	Pain Intensity Measured on Visual Analog Scale (VAS)
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.

Arm/Group Title	Steroid	Clonidine
Arm/Group Description	Epidural steroid injection Epidural steroid	Epidural clonidine injection Clonidine
Measure Participants	0	0

2. Secondary Outcome

Title	Percentage of Pain Relief
Time Frame	Day 0, 3 weeks, 3 months

Outcome Measure Data

Analysis Population Description

The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.

Arm/Group Title	Steroid	Clonidine
Arm/Group Description	Epidural steroid injection Epidural steroid	Epidural clonidine injection Clonidine
Measure Participants	0	0

3. Secondary Outcome

Title	Level of Disability (Oswestry Back Scale)
Time Frame	3 weeks, 3 months

Outcome Measure Data

Analysis Population Description

The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.

Arm/Group Title	Steroid	Clonidine
Arm/Group Description	Epidural steroid injection Epidural steroid	Epidural clonidine injection Clonidine
Measure Participants	0	0

4. Secondary Outcome

Title	Adverse Events
Time Frame	Day 0, 3 weeks, 3 months

Outcome Measure Data

Analysis Population Description

The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.

Arm/Group Title	Steroid	Clonidine
Arm/Group Description	Epidural steroid injection Epidural steroid	Epidural clonidine injection Clonidine
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	The study was terminated and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.
Arm/Group Title	Steroid		Clonidine
Arm/Group Description	Epidural steroid injection Epidural steroid		Epidural clonidine injection Clonidine
All Cause Mortality
	Steroid		Clonidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Steroid		Clonidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Steroid		Clonidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.