Clinical trial NCT04611529
Conditions: Low Back Pain
Sponsor: Montefiore Medical Center
Start date: 2021-03-02; Completion date: 2023-06-30
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.

Detailed description:

Arms: arm 1: Oral ibuprofen 400mg Topical diclofenac 4gm arm 2: Oral ibuprofen 400mg Topical placebo arm 3: Oral placebo Topical diclofenac 4gm
Interventions: intervention 1: Ibuprofen 400 mg intervention 2: Topical diclofenac
Intervention descriptions: intervention 1: Ibuprofen 400mg intervention 2: Diclofenac 1% gel 4gm

Protocol documents:
Prot_SAP_000.pdf: 
A Randomized Study of Topical Diclofenac versus Oral 
Ibuprofen for Acute Non-Radicular Low Back Pain
Protocol ID:  2020-12418
NCT04611529


Acute low back pain. Topical diclofenac and oral ibuprofen. 10212020
A randomized study of topical diclofenac versus oral ibuprofen for acute non-radicular low back pain
In industrialized nations such as the United states, low back pain carries a lifetime prevalence of over 
80% and results in an aggregate 2.7 million annual visits to US emergency departments. (1,2) RCT’s 
comparing NSAIDS to placebo support the use of this medication as first-line treatment in patients with 
acute low back pain without sciatica. (3) Despite this, the magnitude of NSAID effectiveness remains 
small, leading patients with low back pain to report persistent pain, analgesic use, and functional 
impairment after an ED discharge. (3,4) Furthermore, the addition of other pharmacologic treatments 
such as oxycodone, muscle relaxants, and benzodiazepines have not improved outcomes when added to 
NSAIDS. (5,6) Topical NSAIDS, such as diclofenac, are effective in the treatment of musculoskeletal pain 
but have not been studied specifically in patients with low back pain. (9) 
The current literature reveals that topical NSAIDS may achieve similar therapeutic effects with fewer 
systemic side effects when compared to oral NSAIDS. For example, an in vivo study comparing oral vs 
topical ibuprofen showed similar concentration of the drug in muscle tissue yet a 300-fold lower plasma 
concentration for patients receiving topical ibuprofen. (7) Multiple studies showed a statistically 
significant reduction in pain when topical diclofenac was compared to placebo in patients with 
musculoskeletal sports injuries. (8) Similarly, when used in patients with chronic musculoskeletal pain, 
topical diclofenac led to a significant reduction in pain after 2 to 4 weeks and no statistical difference 
when compared to oral diclofenac. (9) When used specifically for patients with acute back pain, a single 
study was carried out and showed promising results for the diclofenac patch, but this was open-label, 
uncontrolled, and generally of poor quality. (10)
Given the poor pain and functional outcomes that persist beyond an ED visit for acute musculoskeletal 
low back pain, we propose a clinical trial to test the following three hypotheses:
1)
Combining topical diclofenac gel with oral ibuprofen will result in better LBP functional
outcomes than oral ibuprofen + placebo gel, as measured by improvement in the Roland Morris
Disability Questionnaire 2 days after ED discharge
2)
Combining topical diclofenac gel with oral ibuprofen will result in better LBP functional
outcomes than diclofenac gel + oral placebo, as measured by improvement in the Roland Morris
Disability Questionnaire 2 days after ED discharge
3)
Topical diclofenac + oral placebo and topical placebo + oral ibuprofen will result in comparable
LBP functional outcomes, as measured by improvement in the Roland Morris Disability
Questionnaire 2 days after ED discharge
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020


Acute low back pain. Topical diclofenac and oral ibuprofen. 10212020
Overview
This will be a double-blind, placebo-controlled comparative effectiveness trial in which we enroll 
patients during an ED visit for musculoskeletal LBP and follow them by telephone two and seven days 
later. Patients will be randomized into one of three separate treatment groups: topical diclofenac gel + 
oral ibuprofen, topical diclofenac gel + placebo oral medication, oral ibuprofen + placebo gel. All 
patients will receive a 2-day supply of investigational medication.
Subject selection
Our goal is to include in this study a broad representation of patients with musculoskeletal back pain 
who are likely to respond to the investigational medications and who would not be considered 
candidates for spinal surgery or targeted epidural intervention. We hope for a widely generalizable 
study and therefore will not require diagnoses to be contingent on advanced imaging studies. 
Inclusion criteria:
-Present to ED 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 ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, 
musculoskeletal LBP.
-Patient is to be discharged home. 
- Age 18-69 Enrollment will be limited to adults younger than 70 years because of the increased risk of 
adverse medication effects in the elderly.
-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). Patients with more than two weeks of pain are at increased risk of 
poor pain and functional outcomes.(10)
-Prior to the acute attack of LBP, back pain must occur less frequently than once per month. Patients 
with more frequent back pain are at increased risk of poor pain and functional outcomes.(10) 
-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 
(Appendix)
Exclusion criteria:
-Not available for follow-up
-Pregnant 
-Any analgesic medication use on a daily or near-daily basis
-Allergic to or intolerant of investigational medications
-Open wounds or skin breakdown of the lower back
-Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or 
history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease 
(GFR <60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis 
(transaminases 2x the upper limit of normal)
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020


Acute low back pain. Topical diclofenac and oral ibuprofen. 10212020
Investigational medication
A.
Ibuprofen 400mg orally + Diclofenac 1% gel, 4g topically, every 6 hours as needed 
B.
Ibuprofen 400mg orally + placebo gel topically, every 6 hours as needed 
C.
Diclofenac 1% gel, 4g topically + placebo capsules, orally, every 6 hours as needed
Participants will be instructed to take one capsule of the investigational medication and apply the 
investigational gel together every 6 hours as needed for the pain. All study patients will be given a two-
day supply of investigational medication.
Outcome measures.
1. Roland Morris LBP Disability Questionnaire (RMDQ)--Reproduced in the Appendix. This 24-item LBP 
functional scale is recommended for use in LBP research. (11) Its yes/ no format is amenable to 
telephone follow-up. We have used it successfully to obtain post-ED follow-up in five previous LBP 
studies involving more than 1500 patients.
2. Ordinal pain scale (“severe”, “moderate”, “mild”, or “none”). Study participants will be asked to 
describe their worst back pain in the previous 24 hours.
3. Medication requirements: “What medications did you use to treat your low back pain in the previous 
24 hours?” 
4. Low back pain frequency: “Over the last 24 hours, how often were you in pain?  Not at all, Rarely, 
Sometimes, Usually, Always”.  Low back pain symptomatology is quite variable. Some patients may 
experience no pain unless they move a certain way. Others may experience a constant low level of pain. 
This question will help determine the burdensomeness of the LBP in the patient’s daily life.
5. Satisfaction, as measured by response to this question: The next time you go to the ER with low back 
pain, do you want to get the same combination of medications?
Primary outcome
The change in Roland Morris Disability scale between the baseline ED visit and the two-day follow-up 
(Roland-Morris baseline - Roland-Morris day 2). The baseline questions will refer to the time period 
immediately prior to ED presentation (Before you came to the ER today, were you able to…..).
Secondary outcomes
   The following outcomes will be assessed 2 days and 7 days after ED discharge:
1.
Worst LBP over the previous 24 hours, using a four-point ordinal scale: severe, moderate, mild, 
or none
2.
Frequency of low back pain using the five-point Likert scale: Not at all, Rarely, Sometimes, 
Usually, Always
3.
Use of any analgesic or LBP medication within the previous 24 hours.
4.
Absolute RMDQ score
5.
Able to return to all usual activities
6.
Number of visits to any healthcare provider.
7.
Satisfaction with treatment 
8.
Frequency of adverse events including 
-GI side effects (dyspepsia, nausea, and bleeding)
-application site skin reactions such as dermatitis
-All other side effects
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020


Acute low back pain. Topical diclofenac and oral ibuprofen. 10212020
Randomization and blinding
The pharmacist will perform randomization in blocks of 6 based on a sequence generated at 
http://randomization.com The investigational oral medication will be masked by placing tablets into 
identical capsules, which will be packed with scant amounts of lactose and sealed. The investigational 
topical medication will be masked by placing gel into an unidentified tube. This masking will take place 
in a secure location inaccessible to ED personnel. All clinical staff and patients will be blinded. Patients 
will be presented with one vial and one tube of investigational medication labeled with dosing 
instructions.  
Details of protocol
Prior to discharge from the ED and after the patient’s pain has been controlled, the healthcare provider 
will refer appropriate patients to study personnel for screening. Research associates will ascertain 
baseline socio-demographic information, low back pain history, and baseline variables discussed above. 
Research personnel will provide each patient with a 10-minute educational intervention. This will be 
based on NIAMS’s Handout on Health: Back Pain information webpage (available at 
http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each 
section of the information sheet with the patient and elicit questions. Patients will be discharged with 
one medication vial containing a two-day supply of ibuprofen or placebo and one tube containing a two-
day supply of diclofenac gel or placebo gel. Additionally, the patients will be provided with a measuring 
tape and instructed to measure a 4.5-inch length of gel corresponding to a dose of 4 g of the 
investigational topical medication for each application. Patients will be instructed to use both the oral 
and topical medication together if they have pain. Patients will be cautioned not to take off protocol LBP 
medication without first consulting with a healthcare provider. Patients will be encouraged to follow-up 
with their primary care physician. Research personnel will use REDCap form to capture data. Follow-up 
phone calls will be conducted 48 hours and seven days after ED discharge. Follow-up will be attempted 
daily until successful. For patients difficult to contact, express courier or home visit will be used to 
obtain follow-up information. 
Sample size calculation
We based assumptions on a recently completed RCT of LBP treatment. (11) The mean improvement in 
RMDQ among those who receive an NSAID alone was 10.2. The standard deviation was 8.9. A widely 
accepted minimum clinically important improvement of 5 points on the RMDQ would require those 
randomized to active medication to demonstrate a mean improvement of 15.2 on the RMDQ. Using a 
standard alpha of 0.05 and a beta of 0.20, we determined the need for 60 subjects in each arm. To 
account for protocol violations and patients lost-to-follow-up (typical lost-to-follow-up rate is 5-10%) 
and to ensure sufficient power for the per protocol analysis (in our previous ED-based LBP studies, up to 
1/3 of enrolled patients have not used the medication more than once), we intend to enroll 66 patients 
in each arm (total n= 198).
Analysis
An intention-to-treat analysis will be performed among all patients for whom primary outcome data is 
available. The primary outcome will be a comparison of the change in RMDQ between baseline and day 
2. The mean difference between groups will be reported with 95%CI. For the superiority analyses, if the 
95%CI does not cross zero, the result will be considered statistically significant. For the equivalence 
analysis, if the 95%CI does not cross 5 or -5, the result will be considered statistically significant. For 
patients with missing 2 day follow-up data, we will perform two sensitivity analyses in which we assume 
universally good outcomes among all patients with missing data in one arm and universally bad arms 
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020


Acute low back pain. Topical diclofenac and oral ibuprofen. 10212020
among those with missing data in the other; we will then reverse these assumptions. Secondary 
outcomes will be reported as rates with 95%CI. The between group difference will be reported with 
95%CI. A per protocol efficacy analysis will be conducted among those patients who use the 
investigational medication at least once.
Data Safety Monitoring Committee
This committee will be comprised of Dr. Polly Bijur, PhD, an epidemiologist and Dr. David Esses, MD, the 
director of the Moses ED. The committee will meet every month with the PI to 1) monitor adverse 
events and develop strategies to minimize these; and, 2) monitor recruitment and enrollment. There will 
not be an interim analysis.
Consent
Study personnel will obtain informed consent once the patient’s pain has been controlled and the 
patient is ready for discharge from the ED. The attending physician will assess the patient’s capacity to 
consent to participate in this study. 
Risks/Benefits
NSAIDs are commonly used in more than 2.5 million annual US ED visits for LBP. Regardless of results, 
this study will have a national impact. All study subjects receive an NSAID and thus are likely to benefit. 
In addition to breach of confidentiality, which is unlikely, and inconvenience to the subject, which will 
undoubtedly occur, some subjects will possibly experience adverse medication effects. For the most 
part, these are minor events. Non-steroidals can cause life-threating gastro-intestinal bleeding, but this 
is unlikely in patients screened for gastro-intestinal illness who will take the medication for two days 
only. Non-steroidals increase cardiovascular and risk of renal injury and may worsen blood pressure 
control. When used topically, non-steroidals may cause application site reactions, including dermatitis.
Data Storage & Confidentiality
Data will be stored and maintained in REDCap. Data analysis will occur on password-protected 
computers. Consent documents will be maintained in locked research cabinets. Only study personnel 
will have access to the data and consent documents.
Unblinding
Subject treatment assignments will remain blinded until the final subject has completed follow up and 
all data has been recorded and validated.  Urgent, immediate unblinding due to medical emergency may 
be authorized by the Investigator.  
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020


Acute low back pain. Topical diclofenac and oral ibuprofen. 10212020
1.
Golob A, Wipf J. Low Back Pain. Med Clin N Am 98 (2014) 405–428
2.
Friedman BW, Chilstrom M, Bijur PE, Gallagher EJ. Diagnostic Testing and Treatment of Low Back 
Pain in United States Emergency Departments. SPINE Vol. 35, No. 24, pp E1406–E1411, 2010
3.
Roelofs PD, Deyo RA, Koes BW, Scholten RJ, van Tulder MW. Nonsteroidal anti-inflammatory 
drugs for low back pain: an updated Cochrane review. Spine. 2008;33(16):1766-74.
4.
Friedman BW, O'Mahony S, Mulvey L, Davitt M, Choi H, Xia S, et al. One-week and 3-month 
outcomes after an emergency department visit for undifferentiated musculoskeletal low back 
pain. Annals of emergency medicine. 2012;59(2):128-33 e3.
5.
Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, et al. Naproxen With 
Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A 
Randomized Clinical Trial. JAMA. 2015;314(15):1572-80.
6.
Friedman BW, Irizarry E, Solorzano C, Khankhel N, Zapata J, Zias E, et al. Diazepam is no better 
than placebo when added to naproxen for acute low back pain. Ann Emerg Med. 2017 
Aug;70(2):169-176
7.
Tegeder I, et al. Application of microdialysis for the determination of muscle and subcutaneous 
tissue concentrations after oral and topical ibuprofen administration. Clin Pharmacol Ther. 1999 
Apr;65(4):357-68.
8.
McCarberg B, D’Arcy. Options in topical therapies in the management of patients with acute 
pain. Postgrad Med. 2013 Jul;125(4 Suppl 1):19-24.
9.
Shinde VA, et al. Efficacy and Safety of Oral Diclofenac Sustained release Versus Transdermal 
Diclofenac Patch in Chronic Musculoskeletal Pain: A Randomized, Open Label Trial. J Pharmacol 
Pharmacother. 2017 Oct-Dec;8(4):166-171. doi: 10.4103/jpp.JPP_35_17.
10. Gimbel J, Jacobs D, Pixton G, Paterson C. Effectiveness and safety of diclofenac epolamine 
topical patch 1.3% for the treatment of acute pain due to back strain: an open-label, 
uncontrolled study. Phys Sportsmed. 2011 Feb;39(1):11-8. doi: 10.3810/psm.2011.02.1857
11. Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, et al. Naproxen With 
Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A 
Randomized Clinical Trial. JAMA. 2015;314(15):1572-80.
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020


Acute low back pain. Topical diclofenac and oral ibuprofen. 10212020
Appendix 1. Roland Morris low back pain disability questionnaire
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
Over the last 24 hours, I have stayed home most of the time because of my back pain:
Over the last 24 hours, I changed position frequently to try to get my back comfortable:
Over the last 24 hours, I walked more slowly than usual because of my back:
Over the last 24 hours, I have not been doing any jobs that I usually do around the house 
because of my back pain:
Over the last 24 hours, I used a handrail to get upstairs because of my back pain:
Over the last 24 hours, I lay down to rest more often because of my back pain:
Over the last 24 hours, I have had to hold on to something to get out of an easy chair 
because of my back pain
Over the last 24 hours, I have tried to get other people to do things for me because of 
my back pain:
Over the last 24 hours, I got dressed more slowly than usual because of my back pain:
Over the last 24 hours, I only stood up for short periods of time because of my back pain:
Over the last 24 hours, I tried not to bend or kneel down because of my back pain:    
Over the last 24 hours, I found it difficult to get out of a chair because of my back pain:    
Over the last 24 hours, my back was painful almost all of the time:    
Over the last 24 hours, I found it difficult to turn over in bed because of my back pain:    
Over the last 24 hours, my appetite was not very good because of my back pain:    
Over the last 24 hours, I have had trouble putting on my socks ( or stockings) because of 
the pain in my back or leg:
Over the last 24 hours,  I could only walk short distances because of my back pain:
Over the last 24 hours, I slept less well because of my back:    
Over the last 24 hours, I got dressed with the help of someone else because of my back 
pain:   
Over the last 24 hours, I sat down for most of the day because of my back:   
Over the last 24 hours, I avoided heavy jobs around the house because of my back pain:    
Over the last 24 hours, I was more irritable and bad tempered with people than usual 
because of my back pain,
Over the last 24 hours, I went upstairs more slowly than usual because of my back pain
Over the last 24 hours, I stayed in bed most of the time because of my back pain:    
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
No0     Yes1
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/21/2020

ICF_001.pdf: 
KEY INFORMATION FOR 
A randomized study of topical diclofenac and oral ibuprofen for acute non-radicular low back pain
This research study will compare two pain medications. We are inviting you to take part in the study because you have 
low back pain and it is not known which pain medication is better. This page is designed to give you key information to 
help you decide whether to participate. Ask the research team questions. If you have questions later, the contact 
information for the research investigator in charge of the study is below. 
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST?  
We do not know if pills or creams are better for low back pain. By doing this study, we hope to learn which medicine is 
better at improving pain.
If you agree to participate:

The study doctor will not pick which drug you will take. We will use a computer to place you in one of the two
study groups. The group the computer picks is by chance, like a flip of a coin. You will have an equal chance of 
being in either group. If you want more information about randomization, we will show you a brief video.

You will receive either ibuprofen by mouth or diclofenac by cream or both. We will not tell you which of the two
medicines you get.

This study will end seven days after you leave the emergency room.
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
There is no guarantee that you will benefit personally from being in this study. However, you will definitely be treated with 
at least one standard medication for low back pain. Some participants appreciate knowing they have contributed to 
research that may benefit others in the future. For a complete description of benefits, refer to the Consent Document 
below.
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY?
All medicines used in this study are FDA Approved to treat pain. You should not participate in this study if you do not want 
to leave the choice of medicine up to chance. The study computer picks which medicine you receive instead of a doctor 
choosing. The Detailed Consent provides a list of possible risks for each study medicine.
You do not have to participate in the study to receive medication for your pain but if you don’t participate, you will probably 
be treated with the same medications anyway.. If you decide not to be in the study, your doctor will choose a treatment 
he/she thinks is best for you. For a complete description of alternate treatment/procedures, refer to the Consent 
Document below.
DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any services, 
benefits or rights or access to care you would normally have if you choose not to volunteer.
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS?
The person in charge of the study is Dr. Benjamin Friedman. If you have questions, suggestions, or concerns regarding 
this study or you want to withdraw from the study his contact information is: 718-920-6626
If you have any questions, suggestions or concerns about your rights as a volunteer in this research, contact staff in the 
Einstein Institutional Review Board (IRB) between the business hours of 9am and 5pm EST, Monday-Friday at 718-430-
2253 or irb@einstein.yu.edu.
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/08/2022
IRB EXPIRATION DATE: 12/07/2023


Topical diclofenac and oral ibuprofen. Consent version date 12212020
1
ALBERT EINSTEIN COLLEGE OF MEDICINE
MONTEFIORE MEDICAL CENTER
DOCUMENTATION OF INFORMED CONSENT AND HIPAA AUTHORIZATION
Introduction
You are being asked to participate in a research study called “A randomized study of topical 
diclofenac and oral ibuprofen for acute non-radicular low back pain” 
 Your participation is voluntary -- it is up to you whether you would like to participate. It is fine to say 
“no” now or at any time after you have started the study. If you say “no,” your decision will not affect any 
of your rights, benefits, or access to care.
The researcher in charge of this project is 
called the “Principal Investigator.” His name 
is Benjamin Friedman, MD. You can reach 
Dr. Friedman at:
Office Address: 111 East 210  Street
Bronx, NY 10467
Telephone #: 718-920-6626
For questions about the research study, or if 
you believe you have an injury, contact the 
Principal Investigator or the IRB.
Support for this research study is provided 
by Montefiore’s Department of 
Emergency Medicine
The Institutional Review Board (IRB) of 
the Albert Einstein College of Medicine 
and Montefiore Medical Center has 
approved this research study. The IRB 
# is in the stamp in the upper right 
hand corner. If you have questions 
regarding your rights as a research 
subject you may contact the IRB office 
at 718-430-2253 or by mail:
Einstein IRB
Albert Einstein College of Medicine
1300 Morris Park Ave., Belfer Bldg 
#1002
Bronx, New York 10461
Why is this study being done?
Like you, many people across this country go to an ER to get treatment for low back pain. More than 
twenty different medications are used to treat low back pain but research shows that many of these 
medications don’t really help patients with low back pain but they do cause side effects. The purpose of 
this research study is to compare two commonly used anti-inflammatory medications: ibuprofen tablets 
and diclofenac gel. If you participate in this study, you will be treated with ibuprofen tablets taken by 
mouth or diclofenac gel applied on the skin. You might also get both. These medications are part of a 
class of medications called non-steroidal anti-inflammatory drugs. They are approved by the US Food 
and Drug Administration for the treatment of pain.
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/08/2022
IRB EXPIRATION DATE: 12/07/2023


Topical diclofenac and oral ibuprofen. Consent version date 12212020
2
Why am I being asked to participate?
You are being asked to participate because you are being treated in the ER for low back pain.
How many people will take part in the research study?
You will be one of 198 people who will be participating in this study at Montefiore Medical Center.
How long will I take part in this research?
This research study lasts 7 days.  It will take you about twenty minutes today to complete the study 
paperwork and questionnaires. We will give you the medication, which you will take for the next two 
days only as needed for low back pain. We will then call you in two days and seven days. During each 
of these phone calls, we will ask you questions for about ten minutes.
What will happen if I participate in the study? 
First, you must sign this consent form. Then we will spend 20 minutes asking you questions about your 
low back pain, your medical history, your age, and your ethnicity. We will then randomly (like flipping a 
coin) determine which of the following medication you will receive: a) ibuprofen pills and placebo gel; b) 
diclofenac gel and placebo pills; c) ibuprofen pills and diclofenac gel.
There is an equal chance that you will be assigned to these treatments. You might also receive a gell or 
a pill without any medication in it called a “placebo”. Neither you nor we will know now which treatment 
you received. We will look to see which medication you received once we have completed the study. 
However, the research study doctor can find out what medication you received, in case of an 
emergency. We will give you one vial of medication containing 8 capsules and one tube containing the 
topical gel.  The two medications should always be taken together, at the same time, every 6 hours on 
a full stomach only as needed for low back pain. You will need to use the strip we provided to measure 
the right amount of the gel each time you apply it to your lower back.
Information Banking (Future Use and Storage)
We will destroy the information about you when the study is complete.
Will I be paid for being in this research study?
No. You will not receive any payment or other compensation for taking part in this study.
Will it cost me anything to participate in this study?
Taking part in this study will not involve added costs to you. All study drugs will be given free of charge. 
You or your insurance company will receive the usual bill for your emergency visit and physician 
services.
What will happen if I am injured because I took part in this study?
If you are injured as a result of this research, only immediate, essential, short-term medical treatment 
as determined by Montefiore, will be available for the injury without charge to you personally.
●
No monetary compensation will be offered.
●
You are not waiving any of your legal rights by signing this informed consent document.
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/08/2022
IRB EXPIRATION DATE: 12/07/2023


Topical diclofenac and oral ibuprofen. Consent version date 12212020
3
●
If additional treatment is required as a result of a physical injury related to the research,
necessary medical treatment will be provided to you and billed to your insurance company or to
you as part of your medical expenses.
Immediately report any discomforts, problems or injuries you experience during the course of your 
participation in the study to Dr. Benjamin Friedman at 718-920-6626.
What else do I have to do?
You will need to schedule a follow-up appointment with your doctor following your discharge from the 
emergency department. If you do not feel well at any time, tell or call your doctor or the research study 
doctor immediately. Drugs may cause a reaction that, if not treated promptly, could be life-threatening.  
It is important that you report all symptoms, reactions, and other complaints to the research team. The 
telephone number is on the front page. 
Confidentiality
The researchers and study staff follow federal and state laws to protect your privacy. This part of the 
consent form tells you what information about you may be used and shared in the research described 
in this form. You do not have to sign this form but, if you do not, you may not participate in the research. 
The health information that we may use or disclose for the research described in this form includes 
information from your entire medical record, such as your name, phone number, email, medical 
diagnoses, dates, test results, social security number, medical record numbers, etc. 
Your information and research records will be kept confidential. Your study information will be kept as 
long as they are useful for the research described in this form.
The only people who can see your research records are:

Researchers and other individuals who work with the researchers

Organizations and institutions involved in this research, including those that fund the research,
if applicable

Groups that review research such as central reviewers, Institutional Review Boards, the Office
for Human Research Protections, the US Food and Drug Administration, data coordinating 
centers, and domestic and foreign agencies that regulate research.
The purposes of these uses and disclosures are to (1) conduct the study and (2) make sure the study is 
being done correctly. The information covered under this form may no longer be protected by federal 
privacy laws (such as HIPAA) once disclosed, and those persons who receive your health information 
may share your information with others without your additional permission. All of these groups have 
been asked to keep your information confidential. 
To maintain the integrity of this research study, you generally will not have access to your research-
related personal health information. If it is necessary for your care, your research-related health 
information will be provided to you or your physician.
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/08/2022
IRB EXPIRATION DATE: 12/07/2023


Topical diclofenac and oral ibuprofen. Consent version date 12212020
4
Are there any risks to me?
Risks of Taking Ibuprofen or Diclofenac (NSAIDs)
Common side effects: rash, abdominal pain, nausea, fluid retention, stomach upset
Less common side effects: ringing in the ears, headaches, dizziness
Uncommon side effects: NSAIDs reduces the ability of blood to clot and therefore may increase 
bleeding after an injury. NSAIDs also may cause stomach and intestinal bleeding and ulcers. NSAIDs 
may impair function of the kidneys. Individuals with asthma are more likely to experience allergic 
reactions to NSAIDs. Fluid retention, blood clots, heart attacks, hypertension, and heart failure have 
also been associated with the use of NSAIDs. Intestinal bleeding, heart attacks, and blood clots can kill 
people.
Allergic Reaction to Study Drug
Any drug can cause an allergic reaction, which could be mild or more serious and can even result in 
death. Common symptoms of an allergic reaction are rash, itching, skin problems, swelling of the face 
and throat, or trouble breathing. If you are having trouble breathing, tell your nurse immediately or if at 
home go to the nearest emergency department.
Risks to Women Who Are or May Become Pregnant
Ibuprofen is commonly used in pregnancy but may cause miscarriage or fetal malformations. Because 
of these risks, women cannot take part in this study if they are:
●
Pregnant
●
Trying to become pregnant
Special precautions for using the topical gel
In order to reduce the risk of skin reactions and other adverse events, avoid applying the provided gel 
to open wounds, avoid exposure to sunlight of the treated area, and avoid applying lotions or skin 
products on the same area as the gel. To maximize the effectiveness of the gel, avoid washing or 
bathing the treated area for 1 hour after application and avoid wearing clothes over the treated area for 
10 minutes after application. 
Questionnaire
You can choose not to answer questions that make you feel uncomfortable.
New Findings
If we learn any significant new findings during the study that might influence your decision to 
participate, we will contact you and explain them.
Unknown Risks
We have described all the risks we know. However, because this is research, there a possibility that 
you will have a reaction that we do not know about yet and is not expected. If we learn about other 
risks, we will let you know what they are so that you can decide whether or not you want to continue to 
be in the study.
Are there possible benefits to me?
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/08/2022
IRB EXPIRATION DATE: 12/07/2023


Topical diclofenac and oral ibuprofen. Consent version date 12212020
5
You may or may not receive personal, direct benefit from taking part in this study.  Your participation 
will generate important information that will benefit other people who suffer from low back pain.
What choices do I have other than participating in this study?
You can refuse to participate in this study. If you decide not to participate, the medical care providers at 
this facility will still give you all of the standard care and treatment that is appropriate for you. 
Are there any consequences to me if I decide to stop participating in this study?
No. If you decide to take part, you are free to stop participating at any time without giving a reason. This 
will not affect your care and you will continue to be treated at this facility. However, some of the 
information may have already been entered into the study and that will not be removed.
Can the study end my participation early?
After you have consented to participate and have been determined to be eligible, you will be randomly 
assigned to receive specific study medications. After that point you will remain in the study unless you 
choose to end your participation.
CONSENT TO PARTICIPATE
I have read the consent form and I understand that it is up to me whether or not I participate. I 
know enough about the purpose, methods, risks and benefits of the research study to decide 
that I want to take part in it. I understand that I am not waiving any of my legal rights by signing 
this informed consent document. I will be given a signed copy of this consent form.
Printed name of participant
Signature of participant
Date
Time
Printed name of the research 
associate conducting the 
consent process
Signature
Date
Time
________________________
______________________________________ ______
____
Printed name of the provider 
conducting the consent 
process 
Signature
Date
T
i
m
e
Time
IRB NUMBER: 2020-12418
IRB APPROVAL DATE: 12/08/2022
IRB EXPIRATION DATE: 12/07/2023