Ibuprofen With or Without Acetaminophen for Low Back Pain

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03554018
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.5
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

This is a randomized clinical trial comparing two interventions for acute low back pain:

1. Ibuprofen + acetaminophen

2. Ibuprofen + placebo

Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Drug: Acetaminophen; Drug: Ibuprofen 600 mg; Behavioral: Educational intervention; Drug: Placebo oral capsule	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ibuprofen With or Without Acetaminophen for Acute, Non-radicular Low Back Pain: A Randomized Trial
• Actual Study Start Date: Oct 16, 2018
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acetaminophen Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.	Drug: Acetaminophen; Acetaminophen 500-1000mg every 6 hours; Drug: Ibuprofen 600 mg; Ibuprofen 600mg every 6 hours; Behavioral: Educational intervention; Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)
Active Comparator: Placebo Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.	Drug: Ibuprofen 600 mg; Ibuprofen 600mg every 6 hours; Behavioral: Educational intervention; Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp); Drug: Placebo oral capsule; To match acetaminophen, patients will take one or two capsules every 6 hours

Outcome Measures

Primary Outcome Measures

1. Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire [Baseline and one week after discharge from emergency department]

   The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.

Secondary Outcome Measures

1. Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale [7 days after discharge from emergency department]

   Data collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.

2. Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours. [7 days after discharge from emergency department]

   Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Present to emergency room primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.

• Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the emergency room visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal low back pain.

• Patient is to be discharged home.

• Age 18-69

• Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.

• Pain duration <2 weeks (336 hours).

• Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month.

• Non-traumatic LBP: no substantial and direct trauma to the back within the previous month

• Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire

Exclusion Criteria:

• Not available for follow-up

• Pregnant

• Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis

• Allergic to or intolerant of investigational medications

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, Montefiore Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 19, 2018

More Information

Publications

None provided.

• Responsible Party: Benjamin W. Friedman, MD, Professor of Emergency Medicine, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03554018
• Other Study ID Numbers: 2018-9182
• First Posted: Jun 12, 2018
• Last Update Posted: Sep 22, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Acetaminophen; Ibuprofen

Study Results

Participant Flow

Arm/Group Title	Acetaminophen	Placebo
Arm/Group Description	Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Acetaminophen: Acetaminophen 500-1000mg every 6 hours Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)	Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
Period Title: Overall Study
STARTED	60	60
COMPLETED	57	53
NOT COMPLETED	3	7

Baseline Characteristics

Arm/Group Title	Acetaminophen	Placebo	Total
Arm/Group Description	Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Acetaminophen: Acetaminophen 500-1000mg every 6 hours Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)	Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours	Total of all reporting groups
Overall Participants	60	60	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (12)	41 (13)	41 (12)
Sex: Female, Male (Count of Participants)
Female	29 48.3%	28 46.7%	57 47.5%
Male	31 51.7%	32 53.3%	63 52.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	60 100%	60 100%	120 100%
Duration of low back pain (hours) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [hours]	48	48	48

Outcome Measures

1. Primary Outcome

Title	Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
Description	The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.
Time Frame	Baseline and one week after discharge from emergency department

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen	Placebo
Arm/Group Description	Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Acetaminophen: Acetaminophen 500-1000mg every 6 hours Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)	Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
Measure Participants	57	53
Mean (Standard Deviation) [units on a scale]	11.1 (10.7)	11.9 (9.7)

2. Secondary Outcome

Title	Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale
Description	Data collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.
Time Frame	7 days after discharge from emergency department

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen	Placebo
Arm/Group Description	Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Acetaminophen: Acetaminophen 500-1000mg every 6 hours Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)	Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
Measure Participants	57	53
Count of Participants [Participants]	16 26.7%	15 25%

3. Secondary Outcome

Title	Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours.
Description	Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours.
Time Frame	7 days after discharge from emergency department

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen	Placebo
Arm/Group Description	Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Acetaminophen: Acetaminophen 500-1000mg every 6 hours Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)	Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
Measure Participants	57	52
Count of Participants [Participants]	36 60%	32 53.3%

Adverse Events

Time Frame	48 hours
Arm/Group Title	Acetaminophen		Placebo
Arm/Group Description	Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Acetaminophen: Acetaminophen 500-1000mg every 6 hours Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)		Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention. Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
All Cause Mortality
	Acetaminophen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Serious Adverse Events
	Acetaminophen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Acetaminophen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/60 (8.3%)		2/60 (3.3%)
Gastrointestinal disorders
Diarrhea	3/60 (5%)		1/60 (1.7%)
Nervous system disorders
Drowsiness	2/60 (3.3%)		1/60 (1.7%)

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.