Trial Outcomes & Findings for A Trial of Corticosteroids for Low Back Pain (NCT NCT00290589)

NCT ID: NCT00290589

Last Updated: 2019-08-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 82 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2019-08-07

Participant Flow

Participant milestones

Measure	Intramuscular Methylprednisolone Acetate Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo Placebo intramuscular injection Placebo: Normal saline intramuscular injection
Overall Study STARTED	39	43
Overall Study COMPLETED	37	41
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Intramuscular Methylprednisolone Acetate Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo Placebo intramuscular injection Placebo: Normal saline intramuscular injection
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

A Trial of Corticosteroids for Low Back Pain

Baseline characteristics by cohort

Measure	Intramuscular Methylprednisolone Acetate n=39 Participants Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo n=43 Participants Placebo intramuscular injection Placebo: Normal saline intramuscular injection	Total n=82 Participants Total of all reporting groups
Age, Continuous	39 Years STANDARD_DEVIATION 9 • n=5 Participants	37 Years STANDARD_DEVIATION 8 • n=7 Participants	38 Years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants	43 Participants n=7 Participants	82 Participants n=5 Participants
Duration of Back Pain Prior to Study	48 hours n=5 Participants	48 hours n=7 Participants	48 hours n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intramuscular Methylprednisolone Acetate n=39 Participants Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo n=43 Participants Placebo intramuscular injection Placebo: Normal saline intramuscular injection
Numerical Rating Scale (0-10), an Interval Pain Scale, on Which 0 Indicates no Pain and 10 Indicates the Worst Pain Imaginable	7.1 units on a scale Standard Deviation 3.0	5.8 units on a scale Standard Deviation 3.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intramuscular Methylprednisolone Acetate n=39 Participants Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo n=43 Participants Placebo intramuscular injection Placebo: Normal saline intramuscular injection
Functional Disability Scales	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 11.0

SECONDARY outcome

Timeframe: Assessed at 1 month

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

Outcome measures

Measure	Intramuscular Methylprednisolone Acetate n=37 Participants Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo n=40 Participants Placebo intramuscular injection Placebo: Normal saline intramuscular injection
Number of Patients Using Analgesics	8 Participants	17 Participants

Adverse Events

Intramuscular Methylprednisolone Acetate

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intramuscular Methylprednisolone Acetate n=37 participants at risk Methylprednisolone acetate 160mg intramuscular injection intramuscular methylprednisolone acetate: Intramuscular methylprednisolone acetate 160mg	Placebo n=43 participants at risk；n=41 participants at risk Placebo intramuscular injection Placebo: Normal saline intramuscular injection
General disorders Drowsiness	16.2% 6/37 • Number of events 6	11.6% 5/43 • Number of events 43
Gastrointestinal disorders Stomach Pain	10.8% 4/37 • Number of events 4	4.7% 2/43 • Number of events 43
Nervous system disorders Mood Change	2.7% 1/37 • Number of events 1	0.00% 0/43
Gastrointestinal disorders Bloating (Gastrointestinal)	0.00% 0/37	2.3% 1/43 • Number of events 1
General disorders Other	2.7% 1/37 • Number of events 1	4.7% 2/43 • Number of events 2

Additional Information

Benjamin W. Friedman, MD, MS

Montefiore Medical Center

Phone: (718)920-6266

Email: befriedm@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place