A Trial of Corticosteroids for Low Back Pain

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00290589
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Duration (Months): 50
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Low back pain is a common symptom that functionally disables many people. When the low back pain is accompanied by pain that shoots down the leg, it is felt to be caused by a herniated disc. We are conducting this study to determine if a powerful anti-inflammatory agent will decrease the pain and functional impairment that is associated with this illness.

Condition or Disease	Intervention/Treatment	Phase
Radicular Low Back Pain	Drug: Intramuscular methylprednisolone acetate; Drug: Placebo	Phase 3

Detailed Description

This is a randomized, double-blind placebo-controlled clinical trial evaluating intramuscular methylprednisolone acetate as adjunctive therapy for radicular low back pain. This trial randomizes subjects after they had been evaluated and treated in the ED and are ready for discharge. All subjects are followed by telephone call one week and one month after ED discharge. In addition to the steroid injection, all subjects are given a complimentary one week supply of naproxen 500 mg tablets and oxycodone 5mg/ acetaminophen 325 tablets and a detailed low back pain instruction sheet. This study was approved by the Montefiore Medical Center institutional review board.

Patients are included if their low back pain lasted less than one week, if they are 50 years old or younger, and if they had not experienced any direct trauma to the back during the previous week. Low back pain is described as pain originating below the tips of the scapulae and above the buttocks.Patients are only included if their straight leg raise test, as described below, is positive. Patients are excluded if the emergency physician felt that there is a high likelihood that the patient has a secondary cause of low back pain, e.g., metastatic bone disease or infection. Patients are also excluded for temperature greater than 100.3 degrees, pregnancy, lactation, allergy to or intolerance of a study medication. Patients can only enroll once. Patients can not have had another episode of back pain within four weeks prior to the current back pain attack. Patients are excluded for systemic steroid use within four weeks, a history of back surgery, a neoplasia known to metastasize, a chronic pain syndrome, an inflammatory arthritis, suspected vascular, urologic or gynecologic pathology, or direct blunt trauma to the back within the previous week.

Rationale for the straight leg raise test: Although the true test characteristics of the straight leg raise test are unknown, a positive ipsilateral straight leg raise is felt to be a sensitive marker for a herniated intervertebral disc. Therefore, if this test is negative, it can help rule-out the disease. To maintain a homogenous cohort, subjects were stratified based on results of the straight leg raise test. Many definitions of the straight leg raise test exist. In order to identify distinct populations, the research assistants were given a strictly-defined, conservative definition of this test: namely, the test was considered positive if a subject had ipsilateral pain shooting below the knee when either leg was raised between 30 and 70 degrees, as measured with a protractor. Contralateral pain below the knee, considered more specific for a herniated disc, was also considered a positive straight leg raising test.

All patients with low back pain are treated at the discretion of the attending physician. When the patient's pain had been controlled to a level sufficient for the patient to be discharged, the patient is asked for consent to participate as a research subject. After consent is obtained, subjects receive an intramuscular injection of methylprednisolone acetate or placebo. All subjects are discharged with a "back pack" containing 14 tablets of naproxen 500mg, 12 tablets of oxycodone 5mg/ acetaminophen 325 tablets, and a standardized discharge instruction sheet.

Subjects are followed-up by telephone at one week and one month after discharge. At each of these telephone interviews, research assistants read standardized questions about pain and activity limitations from the data collection instrument.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Utility of Intramuscular Corticosteroids for Radicular Low Back Pain
• Study Start Date: Jun 1, 2003
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intramuscular methylprednisolone acetate Methylprednisolone acetate 160mg intramuscular injection	Drug: Intramuscular methylprednisolone acetate; Intramuscular methylprednisolone acetate 160mg; Other Names: steroid
Placebo Comparator: Placebo Placebo intramuscular injection	Drug: Placebo; Normal saline intramuscular injection; Other Names: saline solution

Outcome Measures

Primary Outcome Measures

1. Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable [1 month]

   Improvement in Numerical Rating Scale between the time of the emergency department visit and the one month telephone call is rated on an 11-point scale ranging from 0-10 with 0 indicating no pain and 10 indicating worse pain imaginable.

2. Functional Disability Scales [1 month]

   The low back pain functional disability scale is the Roland Morris Disability questionnaire score (RMDQ). The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.

Secondary Outcome Measures

1. Number of Patients Using Analgesics [Assessed at 1 month]

   Use of analgesics for low back pain (within the previous 24 hours)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 21-50 years old, non-traumatic low back pain for one week or less,

Exclusion Criteria:

• fever, pregnancy, lactation, allergy or intolerance to study medication, suspected active oncologic, urologic, or gynecologic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

• Principal Investigator: Benjamin W Friedman, MD, MS, Albert Einstein College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benjamin W. Friedman, MD, Prof. Emergency Medicine, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT00290589
• Other Study ID Numbers: 03-05-107
• First Posted: Feb 13, 2006
• Last Update Posted: Aug 7, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by Benjamin W. Friedman, MD, Prof. Emergency Medicine, Montefiore Medical Center: low back pain; emergency department; corticosteroids
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Arm/Group Title	Intramuscular Methylprednisolone Acetate	Placebo
Arm/Group Description	Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo intramuscular injection Placebo: Normal saline intramuscular injection
Period Title: Overall Study
STARTED	39	43
COMPLETED	37	41
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Intramuscular Methylprednisolone Acetate	Placebo	Total
Arm/Group Description	Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo intramuscular injection Placebo: Normal saline intramuscular injection	Total of all reporting groups
Overall Participants	39	43	82
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	39 (9)	37 (8)	38 (9)
Sex: Female, Male (Count of Participants)
Female	21 53.8%	22 51.2%	43 52.4%
Male	18 46.2%	21 48.8%	39 47.6%
Region of Enrollment (Count of Participants)
United States	39 100%	43 100%	82 100%
Duration of Back Pain Prior to Study (hours) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [hours]	48	48	48

Outcome Measures

1. Primary Outcome

Title	Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable
Description	Improvement in Numerical Rating Scale between the time of the emergency department visit and the one month telephone call is rated on an 11-point scale ranging from 0-10 with 0 indicating no pain and 10 indicating worse pain imaginable.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intramuscular Methylprednisolone Acetate	Placebo
Arm/Group Description	Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo intramuscular injection Placebo: Normal saline intramuscular injection
Measure Participants	39	43
Mean (Standard Deviation) [units on a scale]	7.1 (3.0)	5.8 (3.5)

2. Primary Outcome

Title	Functional Disability Scales
Description	The low back pain functional disability scale is the Roland Morris Disability questionnaire score (RMDQ). The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intramuscular Methylprednisolone Acetate	Placebo
Arm/Group Description	Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo intramuscular injection Placebo: Normal saline intramuscular injection
Measure Participants	39	43
Median (Inter-Quartile Range) [units on a scale]	0	0

3. Secondary Outcome

Title	Number of Patients Using Analgesics
Description	Use of analgesics for low back pain (within the previous 24 hours)
Time Frame	Assessed at 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intramuscular Methylprednisolone Acetate	Placebo
Arm/Group Description	Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo intramuscular injection Placebo: Normal saline intramuscular injection
Measure Participants	37	40
Count of Participants [Participants]	8 20.5%	17 39.5%

Adverse Events

Arm/Group Title	Intramuscular Methylprednisolone Acetate		Placebo
Arm/Group Description	Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg		Placebo intramuscular injection Placebo: Normal saline intramuscular injection
All Cause Mortality
	Intramuscular Methylprednisolone Acetate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/41 (0%)
Serious Adverse Events
	Intramuscular Methylprednisolone Acetate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Intramuscular Methylprednisolone Acetate		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/37 (32.4%)		10/43 (23.3%)
Gastrointestinal disorders
Stomach Pain	4/37 (10.8%)	4	2/43 (4.7%)	43
Bloating (Gastrointestinal)	0/37 (0%)	0	1/43 (2.3%)	1
General disorders
Drowsiness	6/37 (16.2%)	6	5/43 (11.6%)	43
Other	1/37 (2.7%)	1	2/43 (4.7%)	2
Nervous system disorders
Mood Change	1/37 (2.7%)	1	0/43 (0%)	0

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.