The Effect of a Brief Pre-operative Pain Medication Educational Video on Post-operative Prescription Opioid Medication Use in Patients Undergoing Spine Surgery. A Randomized Controlled Trial
Phase: NA
Conditions: Low Back Pain, Opiate Addiction, Neck Pain
Sponsor: Brooke Army Medical Center

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 1 of 18 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
CLINICAL TRIALS: NCT02674711 
7 
4 May 2018 
8 
 
9 
 
0 
1.  PROTOCOL TITLE:  The Effect of a Pain Medication Educational Approach before Spinal Surgery on 6-
1 
month Post-Operative Use of Opioid Medication: A Randomized Clinical Trial 
2 
 
3 
2.  ABSTRACT   
4 
Background:  Opioid-based pain medication use and prescription has increased dramatically in the last two decades, 
5 
leading to high rates of overdose and utilization for patients with chronic non-cancer pain, despite lack of evidence 
6 
to support its use.  Very little research has looked at educational strategies to help address this problem. 
7 
Design:  Randomized clinical trial 
8 
Methods:  Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to 
9 
spine surgery.  Patients that consent and enroll will be randomized to receive either a brief educational video at this 
0 
appointment or usual care.  Patients will be followed after surgery weekly for the first month, and then again at 6 
1 
months to determine their self reported opioid medication utilization patterns. Pain medication prescription and 
2 
healthcare utilization will also be abstracted from the MDR healthcare database. 
3 
Summary:  The results from this study will help inform and develop best practice for managing patients taking 
4 
opioid medication for surgical pain. 
5 
 
6 
3.  OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS.  
7 
This study is a continued project in a line of research aimed at improving the quality of spinal pain 
8 
management. The purpose of this project is to assess the impact of an educational tool that addresses the latest 
9 
evidence regarding the use of opioid medication in a patient-centric fashion.  We will assess the impact this 
0 
shared-decision making educational tool has on 12 month health care utilization post operatively and the self 
1 
reported use of narcotic pain medication usage for the 6 months following lumbar spine surgery. 
2 
 
3 
Specific Aim 1: Evaluate the differences in opioid medication use for the 12-month period after surgery in 
4 
subjects that received the education prior to surgery compared to those that received usual care education. 
5 
 
6 
Specific Aim 2: Compare the changes in self-reported outcome measures (pain, disability, and sleep) between 
7 
groups over the 6-month period after surgery. 
8 
 
9 
Specific Aim 3: Describe the sociodemographic factors and healthcare utilization in enrolled subjects for the 12 
0 
months leading up to a surgical procedure for the lumbar spine. Identify factors that could account for 
1 
differences in opioid medication, and any potential interaction effect between intervention, opioid use, and 
2 
clinical outcomes following surgery. 
3 
Regional Health Command-Central (RHC-C) 
Institutional Review Board 
 
HUMAN SUBJECTS RESEARCH  
 PROTOCOL APPLICATION – Part B 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 2 of 18 
 
 
4 
 
5 
 
6 
4.  MILITARY RELEVANCE  
7 
The U.S. Armed Forces are experiencing alarming rates of post-war chronic pain related to musculoskeletal 
8 
disorders.1  Pain is reported by 40% of OIF/OEF/OND veterans.2 Chronic pain after musculoskeletal injury is 
9 
the leading cause of medical discharge from service3 and a primary source of disability in the U.S. 
0 
Military.4,5  The costs of chronic pain related disability to the Department of Defense exceed $1.5 billion 
1 
annually.6 In 2007, musculoskeletal injuries resulted in approximately 2.4 million medical visits to military 
2 
treatment facilities and accounted for $548 million dollars in direct patient care costs.7 The cumulative 
3 
incidence of injuries requiring an outpatient visit in U.S. Army entry-level training is about 25% for men and 
4 
55% for women.8,9 Physical training and sports-related activities account for up to 90% of all injuries8,10 and 
5 
80% of these injuries are considered overuse in nature.11,12 
6 
 
7 
Military personnel are especially susceptible to the burden of chronic pain. Higher rates of chronic pain are 
8 
observed in veterans compared to the general population.13 Nearly 1 million veterans are prescribed opioids for 
9 
musculoskeletal conditions, and over half of these individuals chronically use opioids.14,15 Military personnel in 
0 
combat settings are expected to perform duties in extreme operational environments that require very intense 
1 
physical demands. The body armor and full combat load can be in excess of 120 pounds, which increases the 
2 
physical demands even further and leaves military personnel at greater risk for back injury and other 
3 
musculoskeletal disorders.16 In a survey by Konitzer et al., U.S. Army soldiers reported an increase in the 
4 
incidence of back, neck, and upper extremity pain during deployment.16 Considering the demands of a combat 
5 
load, the incidence of lower extremity musculoskeletal injury is also common among soldiers, which results in 
6 
significant lost workdays.17 
7 
 
8 
The U.S. Military faces a post-war chronic pain epidemic. Chronic pain after musculoskeletal injury is the 
9 
leading cause of medical discharge and related to a growing rate of opioid addiction.18-22 Traditional medical 
0 
management has failed to correct this chronic pain epidemic. 
1 
 
2 
5. BACKGROUND AND SIGNIFICANCE.  
3 
Historical Perspective: 
4 
Initial estimates of addiction risk based on data in the 1980s appear to have been very underinflated, and 
5 
therefore the risk to benefit ratio for prescribing opioids for chronic non-cancer pain seemed acceptable.23 
6 
Initially it was thought that less than 1% of patients would develop a dependency, but recent research shows 
7 
that the actual number may be as high as 35%24. This has also led to a 10-fold increase in prescription of opioids 
8 
in the last 2 decades, and the drug overdose death rates have tripled since 1990.25 In fact, drug overdose is the 
9 
2nd highest cause of accidental death in North America after motor vehicle accidents.25 
0 
 
1 
Economical Impact of Opioid Abuse: 
2 
The impact of opioid abuse is felt in various ways.  While the effectiveness of opioids for chronic non-cancer 
3 
pain is questionable, and not recommended for routine use in various clinical guidelines26,27, prescription rates 
4 
continue to rise,28 at an alarming rate of 300-600% over the last 10-20 years.  Despite there being almost 15,000 
5 
deaths due to prescription pain killer abuse in the U.S. in 200825, this only represents a fraction of the problem.  
6 
For every one death, there are 10 treatment admissions for abuse,29 32 emergency department visits,30 130 
7 
people who abuse pain killers31, and 825 non-medical users of opioids.31 The chronic pain epidemic in the U.S. 
8 
costs can also be measured indirectly by looking at the excess of $560 billion annually in healthcare expenses, 
9 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 3 of 18 
 
and lost productivity.32 This epidemic is punctuated by escalating use of opioids leading to a reported 22.6 
0 
million addicted users.26  
1 
Musculoskeletal injury and disorders are the leading cause of chronic pain in the U.S.32   Back pain is the most 
2 
common of all of these musculoskeletal disorders.33  In fact an increase of 423% in expenditures related to 
3 
opioids for back pain has been recently seen.33 Because of these factors, the costs associated with chronic pain 
4 
disability continue to rise.33  
5 
 
6 
Spine Surgery: 
7 
Data suggest that the rate of lumbar spine surgery in the United States has continually increased through the 
8 
1980’s and 1990’s 34,35.  Furthermore, there is significant geographic variation in rates of spine surgery within 
9 
the United States 36 and between the United States and other developed countries 37. Consistent with this, the 
0 
postoperative recommendations provided to these patients vary widely and may not be based upon the best 
1 
available evidence 38.  The observed variation in geographic differences in surgical rates and postoperative 
2 
recommendations may adversely affect the clinical outcomes associated with lumbar spine surgery.  Previous 
3 
research has demonstrated that the clinical outcomes following lumbar disc surgery are suboptimal with many 
4 
patients experiencing recalcitrant pain, disability and reduced quality of life 39-43.  Prolonged opiate use after 
5 
cercvial surgery is also s problem.75  Indeed, unsuccessful spine surgery has been described as a major health-
6 
care problem 44.   
7 
 
8 
Opioid-based drugs are often used to help manage pain after spinal surgery.19,45,46 However, it is also used often 
9 
to manage spine pain in general, even prior to surgical interventions.33 This is despite a recent systematic review 
0 
that found only a very modest affect, and that was in the short term.47 The outcomes for chronic pain, greater 
1 
than 4 months, were not available.47  Even the Cochrane collaboration back group has stated that “the benefit of 
2 
opioids in clinical practice for the long-term management of chronic [low back pain] remains questionable.”48  
3 
Other studies show that when patients receive opioids for treatment of non-cancer pain, high levels of pain 
4 
remain persistent and their quality of life decreases.49 
5 
 
6 
Ironically, pre-operative use of opioid medications is actually a predictor of worse outcome after spine 
7 
surgery.50  Another study found that 1/3 of patients were still using opioid pain medication one year after their 
8 
spine surgery.51 
9 
 
0 
 
1 
Opioid Abuse in the Military 
2 
Abuse of opioid pain medication may be even higher in the military.18,20,21 The U.S. Military faces a post-war 
3 
chronic pain epidemic. Chronic pain after musculoskeletal injury is the leading cause of medical discharge and 
4 
related to a growing rate of opioid addiction. Traditional medical management has failed to correct this chronic 
5 
pain epidemic. 
6 
 
7 
Education Initiatives/Intervention 
8 
Most clinical guidelines recommend an informed decision process between the provider and the patient.  Deyo 
9 
and colleagues argue that patients need to be better social support and honest preparation to deal with their 
0 
circumstances:  “Patients need realistic expectations despite product marketing, media reports, and medical 
1 
rhetoric that promise a pain-free life.”33 
2 
 
3 
The American Pain Society and the American College of Physicians has provided guidance on prescription of 
4 
opioid therapy in patients with chronic, non-cancer pain.52 They strongly recommend an educational approach, 
5 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 4 of 18 
 
with continuing discussion that should include goals, expectations, potential risks, and alternatives to an opioid 
6 
trial. 52  In fact one of the critical research gaps identified by a panel of experts was further evidence on the 
7 
utility and value of the informed consent process with patients.53  This includes improving educational strategies 
8 
and processes that can better inform patients about the true risks and dangers of opioid medication use. 
9 
 
0 
Dr. Mike Evans is a physician-professor at the University of Toronto in Canada, and chaired the patient 
1 
education committee for the College of Family Physicians of Canada.  He runs the Evans Health Lab 
2 
(evanshealthlab.com) which “fuses clinicians and creatives, filmmakers and patients, social entrepreneurs and 
3 
best evidence to create "edutaining" healthcare information.”  His lab has developed an educational video titled 
4 
“Best Advice for People Taking Opioid Medication” which is available open source on youtube.com.  The 
5 
video can be found at this link: 
6 
https://www.youtube.com/watch?v=7Na2m7lx-hU 
7 
 
8 
This particular video has been endorsed by the Centre for Addiction and Mental Health and the Canada Health 
9 
Infoway.  It summarizes the state of the evidence, balancing the benefits and the dangers of opioid use, in a very 
0 
user friendly and patient-centric manner.  These types of educational tools have the potential to improve the 
1 
shared decision making process between patients and providers about to prescribe a trial of opioid medications.   
2 
 
3 
To date NO randomized clinical trials have specifically evaluated the effect of patient education on outcomes or 
4 
modification of opioid usage post surgery. 
5 
 
6 
6.  RESEARCH DESIGN  Randomized controlled trial with 2 intervention arms.  
7 
 
8 
7.  RESEARCH PLAN 
9 
 
0 
7.1 Selection of Subjects 
1 
 
2 
7.1.1. Subject Population. Subjects will be adults 18 years or older that are already scheduled for a spinal surgery in the 
3 
neurosurgery or ortho spine clinic.  
4 
 
5 
 
6 
 
7 
7.1.2. Source of Research Material.  
8 
Source of Research 
Material 
Clinical 
Purposes 
(Y/N) 
Research 
Purposes 
Oswestry Disability Index 
N 
Y 
Neck Disability Index 
N 
Y 
Pain Catastrophizing 
Index 
N 
Y 
Fear Avoidance Belief 
Questionnaire 
N 
Y 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 5 of 18 
 
Numeric Pain Rating 
Scale 
N 
Y 
Healthcare Utilization 
(MDR Healthcare 
Database) 
Y 
Y 
The Opioid Risk Tool 
N 
Y 
AHLTA 
Y 
Y 
 
9 
7.1.3. Inclusion and Exclusion Criteria.        
0 
 
1 
Inclusion criteria (all of the following) 
2 
(a) Any patient currently scheduled for a pre-operative appointment with an orthopaedic spine surgeon or 
3 
neurosurgeon specifically for a lumbar or cervical procedure. 
4 
(b) Surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic) 
5 
(c) Between the age of 18 - 65 years 
6 
(d) Read and speak English well enough to understand the education, provide informed consent and follow 
7 
study instructions (the surgeon, associate investigator, or research assistants will make this 
8 
determination.  Any patient that needs an interpreter will not be allowed to enroll). 
9 
 
0 
Exclusion criteria (any of the following) 
1 
(a) Known aversion or allergy that would prevent the patient from taking any opioid-based pain medication 
2 
 
3 
 
4 
7.1.4. Description of the Recruitment and Prescreening Process.  As we are targeting patients that have already 
5 
made a decision to have surgery, they will already have been scheduled for a pre-operative visit that typically takes 
6 
place 1-2 days before their surgical procedure.  Before coming to this appointment, patients are typically told to set 
7 
aside the entire morning (4-5) hours for the pre-operative planning procedures as standard of care.  When they 
8 
come in for this visit, the nurse or a research assistant will ask them if they would be interested in participating in 
9 
the study. The current nurse that works in this department is not on active duty, and if any research assistants or 
0 
investigators assist in this process, they will be in civilian clothing so their rank is unknown.  Each week, the MSA 
1 
in neurosurgery has a list of patients that are coming in for pre-operative appointments and she knows the 
2 
procedures that they are scheduled to have.  She will identify those that are having the procedure of interest, and 
3 
remind the nurse seeing these patients to ask the patient if they would be interested in participating.  Patients are 
4 
always told to reserve the entire morning for pre-op as it can take several hours.  Each patient will be told that this 
5 
will add 20-30 minutes to their appointment.  The MSA will also be able to notify a research assisting or associate 
6 
investigator the week before of the days where there may be eligible patients coming in for a pre-operative 
7 
appointments.  These individuals will be available in the clinic on those days where a potential subject is coming in 
8 
for a pre-operative appointment. As part of the pre-operative appointment that is usually taken care of by the nurse 
9 
or physician’s assistant, they will ask the patient if they are interested in participating and if they would like to 
0 
know more about the study. . If they agree, they will be consented and if they meet the inclusion/exclusion criteria, 
1 
they will be enrolled in the study.    
2 
 
3 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 6 of 18 
 
7.1.5. Subject Screening Procedures.  Screening will be performed by clinical members of the neurosurgery 
4 
department, associate investigators, or research assistants listed on this protocol. In some cases it may be one of the 
5 
surgeons if they are listed as an AI on this study.  After providing informed consent, screening will occur by a brief 
6 
interview and medical records review as a part of the patients normal pre-operative appointment.  Essentially they 
7 
will make sure that the patient meets the inclusion/exclusion criteria, and that they are scheduled for the surgical 
8 
procedure of interest. 
9 
 
0 
7.1.6. Consent Process. An investigator or research assistant will conduct the consent process for participation in 
1 
this study, in the presence of a witness with the subject utilizing the approved informed consent and HIPAA 
2 
documents in a private setting.  The investigator will inform the subject that the study involves research and explain 
3 
the purpose and procedures entailed in this study. Furthermore, the subjects will be informed of the approximate 
4 
amount of subjects involved in the study. In addition, any foreseeable risks, discomforts, and benefits will be 
5 
explained.  The voluntary nature of the participation will be stressed, and subjects will be reminded by study 
6 
personnel throughout their participation that they may elect to withdraw from the study at any time. Subjects will be 
7 
assured that a decision not to participate will have no effect on their military status or ability to access health care; 
8 
yet, if the subject chooses to participate he/she will be informed that all records identifying the subject are 
9 
maintained confidentially by the PI in a password protected electronic file and all hard copies are maintained in a 
0 
locked file cabinet that only the PI and study team have access to. Subjects electing to withdraw from the study will 
1 
not participate in any data collection or other procedures associated with this study. The investigative team may 
2 
terminate a subject’s participation in the study at any time he/she feels this to be in the subject’s best interest (i.e., 
3 
safety, health, etc). Moreover, subjects will be provided with the appropriate contact information of whom to speak 
4 
to about their rights and whom to speak with should the subject have any questions.  
5 
 
6 
Subjects will be given ample time to ask questions, read and understand the consent form and take it home (if 
7 
he/she chooses) so the research can be discussed with friends and family prior to participation.  Upon completion of 
8 
the informed consent process and after all concerns have been addressed the subject, the individual obtaining 
9 
consent along with an impartial witness will sign the approved Institutional Review Board consent and HIPAA 
0 
forms. A copy of the signed documents will be offered to the subject, and the original signed document will be 
1 
placed in the subject’s study record. The informed consent process will occur and the informed consent document 
2 
will be signed by all parties prior to any/all study related procedures performed. 
3 
 
4 
APRIL 2018:  As part of an amendment extending collection of health care utilization to one year after study enrollment, we 
5 
are requesting to collect this additional data under a waiver of informed consent and a waiver of HIPAA authorization.  At the 
6 
time of this amendment, all follow up with enrolled subjects has been completed and we are no longer in contact with 
7 
participants.  The research remains minimal risk to subjects and their privacy.  The amendment does not adversely affect their 
8 
rights and welfare since it is merely an extension of the healthcare utilization review for which they have already provided 
9 
consent and authorized for collection of PHI.  It is not practicable to contact all of the subjects and have them re-consent in 
0 
order to obtain HIPAA authorization for this minor change in data collection (12 instead of 6 months). 
1 
 
2 
 
3 
7.1.7. Compensation for participation.  None 
4 
 
5 
 
6 
7.2 Drugs, Dietary Supplements, Biologics, or Devices.   
7 
 
8 
7.2.1  N/A  
9 
 
0 
7.2.2  N/A  
1 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 7 of 18 
 
 
2 
7.3. Study Procedures/Research Interventions.  
3 
After consenting, meeting inclusion criteria, and enrollment, all participants will complete several standard self-
4 
report questionnaires related to medical history, social demographic, and psychosocial variables that are related 
5 
to low back pain, and often used in clinics as standard care in managing patients with spinal pain. Patients 
6 
undergoing lumbar spine surgery will fill out the OSW and patients undergoing cervical spine surgery will fill 
7 
out the NDI. They will then be randomized to either receive the education, or only usual care (which is the 
8 
typical information the surgeon provides the patient verbally).  All patients will receive the usual care education 
9 
from their surgeon.   
0 
 
1 
Randomization: 
2 
          Subjects will then be randomized into one of two arms (Group I = Educational Video, Group II= Usual 
3 
Care Education).  The method of group assignment will be sequentially numbered opaque sealed envelopes 
4 
(SNOSE). To minimize the risk of predicting the treatment assignment of the next eligible patient, 
5 
randomization will be performed in permuted blocks of two or four with random variation of the blocking 
6 
number. 
7 
 
8 
Education Group: 
9 
The educational video chosen for this education is one created by Dr. Mike Evans, a physician and associate 
0 
professor of Family and Community Medicine at the University of Toronto, CA, with a strong research focus on 
1 
patient engagement. He runs the Health Design Lab which has produced several dozen patient engagement 
2 
videos on a variety of public health topics.  They are well-vetted, strongly based on evidence, and have been 
3 
profiled by organizations such as the Journal of the American Medical Association (JAMA). 
4 
 
5 
The video we are choosing for the educational intervention is titled: Best Advice for People Taking Opioid 
6 
Medication and is available at the URL: http://www.youtube.com/watch?v=7Na2m7lx-hU 
7 
 
8 
The content of the education focus on providing a historical perspective for opioid prescription from the time 
9 
when the risk of dependence was highly underestimated.  The video discusses the current evidence for the effect 
0 
of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid 
1 
usage.  The video is 11 and ½ minutes long. 
2 
 
3 
The consent, enrollment, and video education will take about 20-30 minutes for patients in this group, and occur 
4 
at the end of their pre-operative visit.  The patient will watch the video on a portable Tablet computer. 
5 
 
6 
Usual Care Group:  Patients that are randomized to usual care will only receive the regular instructions about 
7 
opioid usage they typically receive from their surgeon. After they consent and are enrolled, they will fill out the 
8 
questionnaires and then be done with the 1st visit of the study. 
9 
 
0 
All Subjects: 
1 
All subjects will receive the usual care education that is typically given by their surgeon.  That will be left up to 
2 
the discretion of each surgeon.  The screening and enrollment should take no more than 5-10 minutes, and then 
3 
the filling out of self-report questionnaires should take approximately 5-7 minutes.  Subjects in the group that is 
4 
randomized to the education will take an additional 11 minutes to view the educational content. 
5 
 
6 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 8 of 18 
 
All patients will proceed with the surgical procedure as planned. Each week during the 1-month period after the 
7 
surgery, patients will be contacted (phone call, email, and text message - depending on what they consented to). 
8 
They will be reached out to daily until contact is made.  A voicemail will be left stating that “This is [name of 
9 
person] from Brooke Army Medical Center calling in regards to a research study that an individual at this 
0 
number is participating in.  Please call us back at [number] at your convenience.” They will be asked the 
1 
following 6 questions: 
2 
 
3 
1) “On a scale from 1 or 10, what has your average pain been like over the past week?” 
4 
 
5 
2) 1) “On a scale from 1 or 10, what has your least and worst pain been like over the past week?” 
6 
 
7 
3) “Approximately how many times have you taken opioid medication for pain (**Include types) over the past 
8 
week?” [days, times per day] 
9 
 
0 
4) “Approximately how many times have you taken other medication for pain (aspirin, Tylenol, ibuprofen) over 
1 
the past week?” 
2 
 
3 
5) How many days of narcotics pain medication were you prescribed?  (# of days or unknown) 
4 
 
5 
6) How much of that original prescription do you have remaining at this point? (estimate # of days or % left) 
6 
 
7 
 
8 
At the 1-month and 6-month time points they will be asked to fill out the additional clinical outcomes measures 
9 
detailed below (ODI, PCS, PSQI, NPRS).  These can be done in person with a visit to the clinic, over the 
0 
telephone, or by email – depending on what they consented to.  They will be reached out to daily until contact is 
1 
made. 
2 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 9 of 18 
 
 
3 
Assessment 
Visit / Follow Up (F/U) Interval 
Study Day / 
12 months  
prior 
Same 
Day 
1 month 
6 months 
12 months  
after 
period 
Screening           
  
X 
  
  
 
Informed 
  
X 
  
  
 
Consent, discuss 
Plan, etc. 
Randomization 
  
X 
  
  
 
Demographics, 
  
X 
  
  
 
History & 
Physical 
Treatment (video education) 
  
X 
  
  
 
Neck Disability Index (cervical 
surgery) 
  
X 
X 
X 
 
Oswestry Disability Index (lumba
surgery) 
  
X 
X 
X 
 
The Opioid Risk Tool 
  
X 
  
  
 
Pittsburg Sleep Quality Index 
  
X 
X 
X 
 
Pain Catastrophizing Scale 
  
X 
X 
X 
 
Medication use 
  
X 
X 
X 
 
Numeric Pain Rating Scale 
  
X 
X 
X 
 
Healthcare Utilization (MDR 
database) 
X (entire 12 
month period)   
  
 
X (entire 12 
month  
period) 
 
4 
7.3.1 Collection of Human Biological Specimens.  N/A 
5 
 
6 
7.3.1.1 Laboratory evaluations and special precautions. N/A 
7 
 
8 
7.3.1.2 Specimen storage. N/A 
9 
 
0 
7.3.2  Data Collection.  Self-report measures (at baseline on paper forms) will be collected at the end of 1 and 6 months.  
1 
Healthcare utilization will be collected at the end of 12 months. 
2 
 
3 
Self-Report Measures: 
4 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 10 of 18 
 
Oswestry Disability Index (OSW):  The Oswestry Disability Questionnaire, originally described by Fairbank 
5 
et al54 as a condition-specific measure of functional status for patients with LBP. The OSW is a 10-item scale 
6 
with higher numbers indicating greater disability. We will use the modified version that replaces the sex life 
7 
item with an employment/ homemaking item due to poor compliance with the former.55,56  The OSW is widely 
8 
used in research on non-operative management of patients with LBP.57  Our previous research has found the 
9 
modified OSW to be used in this study to have high levels of test-retest reliability among stable patients (ICC = 
0 
0.90), good construct validity, and responsiveness to change for patients with acute LBP, with a minimum 
1 
clinically important difference of 6 points for patients with acute LBP receiving physical therapy.55 It is a form 
2 
often used as standard of care in physical therapy clinics.   
3 
 
4 
Neck Disability Index(NDI):   
5 
The NDI was created to measure pain related disability associated with activities of daily living in people with 
6 
neck pain.76 The NDI contains ten focused sections. Seven items focus on activities of daily living. These 
7 
sections include statements related to personal care, lifting, recreational activities, work, driving, and sleeping. 
8 
Two items focus on the patient’s pain. There is one section that evaluates pain directly. The NDI is easy to 
9 
complete and score. Each item is scored on a 6-point scale and can reach a maximum score of 5; therefore, the 
0 
maximum score is 50. Higher scores indicating higher levels of disability. Content, construct validity and 
1 
reliability of the NDI has been previously shown in patients with neck pain.76, 77 The MCID has been established 
2 
as a change of 13% (or 6.5 points).78 
3 
 
4 
 
5 
The Opioid Risk Tool:  The Opioid Risk Tool is a validated tool to assess the risk of narcotic abuse in patients 
6 
with chronic pain.  It stratifies risk based on age, gender, history of abuse, and psychological disease.  A score 
7 
of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid 
8 
abuse, and a score of 8 or higher indicates a high risk for opioid abuse.58    This tool, based on the way that the 
9 
questions are asked, cannot imply whether the subject currently has a substance abuse issue or a history of one.  
0 
Therefore, utilizing it as an outcome measure does not alter the current course of treatment from the 
1 
neurosurgery staff.  However, because the Army values the ability for service members to seek care for 
2 
substance abuse, all subjects will be reminded that the army does have help for substance abuse with the Fort 
3 
Sam Houston Alcohol and Drug Control Officer (ADCO): 210-295-6345 or Military OneSource at 1-800-342-
4 
9647.  
5 
 
6 
Numeric Pain Rating Scale (NPRS): A 0-10 numeric pain rating scale (‘0’ indicating no pain, and ‘10’ worst 
7 
imaginable pain) will be used to assess LBP intensity.  Numeric pain scales are known to have excellent test-
8 
retest reliability.56  Our previous research has found the NPRS to be responsive to change, with a minimum 
9 
clinically important difference of two points among patients with acute LBP receiving physical therapy.9 It is a 
0 
standard of care measurement taken in physical therapy clinics.   
1 
 
2 
Pain Catastrophizing Scale (PCS): The PCS is a 13-item patient-report scale developed to measure the extent 
3 
to which people catastrophize in response to pain.60  Each item is scored from 0 (‘not at all’) to 4 (‘all the 
4 
time’).  The PCS is reported as a total score, with higher scores indicating greater catastrophizing, and is 
5 
composed of three sub-scales: Rumination (four items; e.g. ‘When I am in pain, I keep thinking about how 
6 
badly I want the pain to stop’), Magnification (three items; e.g. ‘When I am in pain, I become afraid that the 
7 
pain will get worse’), and Helplessness (six items; e.g. ‘When I am in pain, I feel I can’t go on’)  The PCS has 
8 
been shown to have high levels of internal consistency and construct validity.61  Pain catastrophizing has also 
9 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 11 of 18 
 
been found to play a role in the transition from acute to chronic LBP.61  It is a form often used as standard of 
0 
care in physical therapy clinics.   
1 
 
2 
Pittsburg Sleep Quality Index (PSQI)  The Pittsburg Sleep Quality Index (PSQI) is a self-rated questionnaire 
3 
which assesses sleep quality and disturbances.  Clinical properties provide utility in both psychiatric clinical 
4 
pratices and research activities.  Seven “component” scores including: subjective sleep quality, sleep latency, 
5 
sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction 
6 
are generated from 19 individual items.63   Sleep quality may have a significant role in affecting outcomes of 
7 
patients with low back pain as several studies have shown correlation between chronic back pain and quality of 
8 
sleep.70, 71 
9 
 
0 
Fear Avoidance Belief Questionnaire (FABQ): The 72  will be used to measure patients’ beliefs about how 
1 
physical activity and work may affect their pain and perceived risk for re-injury. The FABQ contains two 
2 
subscales; a 7-item work subscale (FABQW), and 4-item physical activity subscale (FABQPA).  Test-retest 
3 
reliability of the FABQ subscales is high,72,73  and validity is supported by associations with disability and work 
4 
loss in patients with acute and chronic LBP,74,75 Heightened fear-avoidance beliefs have been shown to be a risk 
5 
factor for the development of chronic LBP following an acute episode.62,76 Other research suggests it may be 
6 
appropriate for other body regions, specifically evaluating its use in lower extremity injuries within a physical 
7 
therapy setting.77   
8 
 
9 
Healthcare Utilization 
0 
Finally, healthcare utilization data will be collected from the MHS Data Repository (MDR) database and will be 
1 
confirmed via AHLTA. Healthcare utilization data will be used to determine any opioid medication use along 
2 
with any subsequent medical utilization related to low back or neck pain. In order to collect this information a 
3 
DUA will be completed between the researcher team and Patient Administration Systems and Biostatistics 
4 
Activity (PASBA) and the Tricare Management Agency (TMA). Both of these agencies require a signed 
5 
completed IRB protocol prior to submitting the DUA. However, this should not impact the timing of this study; 
6 
as the data pull will be completed no sooner than December 2015. This will provide more than enough time to 
7 
complete the DUA with both agencies and submit the signed DUA to the BAMC IRB prior to performing this 
8 
analysis. Details for the determining healthcare utilization are outlined below: 
9 
 
0 
The goal of the MDR database will be to determine the medication utilization for each of these subjects, as well 
1 
as any other healthcare related to low back pain sought in the 12-month period after treatment in this study. This 
2 
data (type, location, number of clinic visits, types of specialty clinic visits, imaging, and associated medication) 
3 
will allow us to determine the extent of low back pain related healthcare utilization for each subject. 
4 
 
5 
• 
Recording of Extracted Data with Identifiers:  
6 
The data will be provided in a de-identified manner from PASBA.  As they have done before with members of our 
7 
team on prior project, they extract all the required data along with name, age and social security number in order to 
8 
identify the correct subjects that were in our study.  They will then assign a pseudo identification number and match 
9 
that with the list of our subject identification numbers that we provide.  Therefore, the final working set they provide 
0 
us for analysis will not have any identifying PHI/PII associated with it.  If additional follow-up is needed to clarify a 
1 
healthcare utilization event in AHLTA, the research team can check the master subject record (stored on an 
2 
encrypted government computer) in order to link the subject ID to SSN.  Therefore, prior to analysis occurring, the 
3 
identifiers will be eliminated. Confidentiality of protected health information will be maintained by the research staff at 
4 
all times, however it should be minimal at this time. The final working database to be used in the data analysis will 
5 
not include PHI information. 
6 
 
7 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 12 of 18 
 
• 
Location of Extracted and Recorded Data:  
8 
The healthcare utilization data will be primarily extracted from the MDR database and through AHLTA. Even though 
9 
the data is now de-identified, the extracted data will still be maintained in an encrypted, password protected file kept 
0 
at the Physical Therapy Clinic, Brooke Army Medical Center.   
1 
 
2 
• 
Nature of Identifying Data 
3 
Timeframes will be requested in reference to the baseline enrollment date rather than the actual date.  For example, 
4 
the date of appointment will be required initially to determine when the healthcare visit associated with the back pain 
5 
occurred. However, this data will be coded differently in the working spreadsheet. The initial appointment will be 
6 
recorded in weeks from the baseline date of enrollment. If multiple appointments exist, the range of dates will be 
7 
recorded in the final spreadsheet (e.g. the patient was seen over a 4 week window) and the exact appointment days 
8 
will not be included in the master spreadsheet. Analysis of the data will only occur in the de-identified spreadsheet.  
9 
 
0 
• 
Status of the extracted data after completion of the research study:  
1 
The de-identified spreadsheet outlined above will be stored indefinitely on a password-protected computer at the 
2 
Physical Therapy Clinic, Brooke Army Medical Center. 
3 
 
4 
• 
Redundancy: 
5 
In addition to searching the MDR database, at each follow-up visit we will ask subjects if they have utilized 
6 
healthcare resources since the last follow-up (4 and 26 weeks), specifically related to their LBP in 4 categories: visits 
7 
to providers (traditional or complementary/alternative), medications (prescription or over-the-counter), interventions 
8 
(injections, surgery, etc.), or testing (x-rays, MRI, etc.).  
9 
 
0 
 
1 
7.3.3. Human Biological Specimens/Tissue/Data Banking.  
2 
N/A  
3 
 
4 
 Statistical Consideration  
5 
 
6 
7.4  
7 
7.4.1 Sample Size Estimation.  Collection of healthcare utilization will occur in 100% of the subjects as no 
8 
follow-up is required, and therefore no opportunities to collect data from a follow-up visit will be lost.  
9 
Therefore the sample size estimation is based on the secondary outcome variable of self-reported pain and 
0 
function (OSW).  Assuming at least 85% of patients complete the OSW at 6 months, enrollment of 60 subjects 
1 
per group (total sample size 120 subjects) will provide at least 84% power to detect a difference of 12 points (2 
2 
X MCID) on the change in OSW to 26 weeks, assuming a standard deviation in the change in OSW of 16 points 
3 
(treatment effect = 43.8% of one standard deviation). The MCID for both the OSW and NDI has been estimated 
4 
at 6 points.55 Previous work with patients with acute LBP indicate that these estimates of anticipated effect size 
5 
and standard deviation are realistic,78-80 and would be consistent with detecting an effect that is at least slightly 
6 
in excess of the threshold for seeing significant change. The NDI and OSW are similar in length and answer-
7 
type, and as we are expecting a higher number of lumbar patients, we will use the OSW to power this study. 
8 
 
9 
 
0 
Estimate Required Sample Size 
101 
Estimate Participant Drop Out / Withdrawal 
19 
Total Enrollment Requirement 
120 
 
1 
Enrollment at Each Site 
 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 13 of 18 
 
BAMC 
120 
 
2 
 
3 
7.4.2 Primary (i.e., primary outcome variables) and secondary endpoints.  
4 
Primary Outcome Variable: Spinal pain healthcare utilization during the 1 year after enrollment understanding patients are 
5 
likely still receiving care for their surgery at 6 months.  This will include a comparison of imaging orders and types, specialty 
6 
referrals, and medication use (pain and narcotics). 
7 
 
8 
The self-reported outcome measures will also be taken at baseline, 1 month, and 6 months.  
9 
 
0 
7.4.3 Data analysis.  
1 
All data will be analysed in IBM SPSS 21 (Chicago, IL).  Descriptive statistics will be performed to describe 
2 
the sociodemographic (age, sex, race, etc.) and health characteristics (disability, pain intensity, psychosocial 
3 
factors, etc.) of the entire sample, and comparisons made between groups.  Means and standard deviations will 
4 
be computed for continuous data and frequency distributions will be analysed for categorical data.  
5 
 
6 
Specific Aim #1 will be evaluated by determining the RR (risk ratio) for opioid medication use during the 1 
7 
year following surgery between both groups.  Utilization reports will be broken down into the 1st week 
8 
(expected to be the highest), 1st month, and then from 2 through 1 year.  We will also look at all healthcare 
9 
utilization events between patients associated with lumbar ICD-9 codes (Appendix A) in those randomized to 
0 
also view the educational video. 
1 
 
2 
Comparison of self-report outcomes between groups at baseline and 6 months will be performed using a linear 
3 
mixed-effects model, which is flexible in accommodating data assumed to be missing at random (Specific Aim 
4 
#2). The time points will be baseline, 1 month, and 6 months for the measures collected from the patient (self-
5 
report questionnaires).  Significance is set at 0.05 and 95% confidence intervals will be reported for all relevant 
6 
data.  Sensitivity analysis will be run adjusting for other demographic and/or prognostic variables (PCS, pain 
7 
intensity, ESS, etc) that may affect the outcome. 
8 
 
9 
Specific Aim #3 will be determined by comparing the variables between each group and introducing them as 
0 
covariates into the linear mixed-effects model to see if the adjustment influences the differences between each 
1 
group. 
2 
Point estimates with 95% Confidence Intervals will be reported.  
3 
 
4 
7.7 Confidentiality.  The only document that will link the subject to the data indirectly is the master patient list.  
5 
This document will have the patients name, social security number, and assigned subject ID number.  This 
6 
document will be encrypted, password protected, and kept on a CAC-enabled government computer in the BAMC 
7 
physical therapy section, where only approved study personnel will have access to it.  Each subject that consents to 
8 
participate in the study, will also fill out a contact form that will have their name, email address, and phone number.  
9 
These documents will be kept in a binder, locked in a research cabinet in a locked office.  The master patient list 
0 
will be referenced when a research team member needs to contact a subject to coordinate follow-up appointment, 
1 
and needs to correlate the subject ID number with an actual patient.  The master list is also needed for when 
2 
healthcare utilization data is requested from PASBA. At that time, the encrypted file will be emailed to the analyst 
3 
assigned to work on this project using a government email address, that is digitally signed and encrypted in order to 
4 
be HIPAA compliance.  In essence it will be an encrypted document, that is also being sent via encrypted email.  
5 
When PASBA returns the healthcare utilization dataset, they will de-identify the data and it will only have a 
6 
pseudo-ID assigned by the system, along with the subject ID that we had provided. The analysis of the data will 
7 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 14 of 18 
 
occur with a de-identified data set.  The master patient list will be kept for 3 years after the study has been closed 
8 
out, and then destroyed.  The de-identified data will be kept indefinitely for any potential future secondary analysis.   
9 
 
0 
7.7.1 Certificate of Confidentiality.  N/A 
1 
 
2 
8.0  RISKS/BENEFITS ASSESSMENT 
3 
 
4 
8.1 Risks.  Risks are unknown, but none are anticipated 
5 
 
6 
There is always a potential risk for loss of confidentiality, but that risk is minimized because we are  limiting 
7 
access to to only members of the research team, and have protections in place as we have already outlines, to 
8 
protect the information. 
9 
 
0 
 
1 
8.2 Potential Benefits.  There are no direct benefits to the patient. 
2 
 
3 
9.0  ADVERSE EVENTS, UNANTICIPATED PROBLEMS, AND DEVIATIONS 
4 
 
5 
9.1 No adverse events are anticipated for this study as it is employing educational material, which is often used in 
6 
some clinics, but using a novel deployment approach.  There is the possibility that the screen from the tablet may 
7 
be too bright and cause the patient to have to look away, although this would likely be very unlikely and the 
8 
research assistant can step in and help dim the screen with the appropriate settings.  There is also a very minor 
9 
possibility that the patient may drop the tablet and the screen would shatter, sending sharp glass particles around.  
0 
However, the tempered glass on the tablets makes this less likely, and the tablets will have cases which should 
1 
protect them.  None of these potential adverse events are serious, and have a very low likelihood of occurring.  
2 
 
3 
In addition, a regular computer can be used to show the video if the tablet becomes a problem. 
4 
 
5 
If an injury does occur, aid will be provided and the patient will be escorted to receive further medical care.  The 
6 
research assistant will help coordinate this with their PCP.   
7 
 
8 
Deviations: 
9 
Minor protocol deviations will be reported to the IRB during annual review using the protocol deviation tracking 
0 
log P53.  Major deviations will be reported to the IRB within 48 hours by the primary investigator, in accordance 
1 
with HRPP policy memo 5.4 on protocol deviations . 
2 
 
3 
9.2  Reporting Unanticipated Problems Involving Risks to Subjects or Others, Serious Adverse Events and 
4 
Deaths to the RHC-C IRB Office.  
5 
 
6 
All unanticipated problems involving risk to subjects or others, unexpected serious adverse 
7 
events, and all subject deaths related or possibly related to the study will be reported 
8 
promptly providing initial notification of the event as quickly as possible after the research 
9 
team’s knowledge of the event, but within five (5) business days of identification by phone, 
0 
by e-mail, by facsimile (210-916-1650) or via letter addressed to IRB Administrator). A 
1 
complete written report will follow the initial notification within 10 working days. 
2 
 
3 
 
4 
 
5 
 
6 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 15 of 18 
 
9.3  Research Monitor.  N/A 
7 
 
8 
 
9 
10.0 WITHDRAWAL FROM STUDY PARTICIPATION.  Subjects may withdraw at any time by just notifying a member of 
0 
the investigative team.  As the primary outcome measure is healthcare utilization being collected through the MDR 
1 
database, it will not be affected with patient withdrawal.  However, self-report data will not be collected at the 4 and 26-
2 
week follow-up points if patients choose to withdraw and not make those follow-up appointments. 
3 
 
4 
11.0 USAMRMC Volunteer Registry Database. N/A 
5 
 
6 
12.0  REFERENCES.   
7 
  
8 
 
9 
1. 
French MT, McGeary KA, Chitwood DD, McCoy CB. Chronic illicit drug use, health services utilization and the 
0 
cost of medical care. Social science & medicine 2000;50:1703-13. 
1 
2. 
Cifu DX, Taylor BC, Carne WF, et al. Traumatic brain injury, posttraumatic stress disorder, and pain diagnoses in 
2 
OIF/OEF/OND Veterans. Journal of rehabilitation research and development 2013;50:1169-76. 
3 
3. 
Gatchel RJ, McGeary DD, Peterson A, et al. Preliminary findings of a randomized controlled trial of an 
4 
interdisciplinary military pain program. Mil Med 2009;174:270-7. 
5 
4. 
Songer TJ, LaPorte RE. Disabilities due to injury in the military. American journal of preventive medicine 
6 
2000;18:33-40. 
7 
5. 
Lincoln AE, Smith GS, Amoroso PJ, Bell NS. The natural history and risk factors of musculoskeletal conditions 
8 
resulting in disability among US Army personnel. Work 2002;18:99-113. 
9 
6. 
Berkowitz SM, Feuerstein M, Lopez MS, Peck CA, Jr. Occupational back disability in U.S. Army personnel. Mil 
0 
Med 1999;164:412-8. 
1 
7. 
Gregg S. Musculoskeletal Conditions Per M2 Database Analysis for FY 2007. M2 Database. Ft Sam Houston: M2 
2 
Database; 2008. 
3 
8. 
Jones BH, Knapik JJ. Physical training and exercise-related injuries. Surveillance, research and injury prevention 
4 
in military populations. Sports medicine (Auckland, NZ 1999;27:111-25. 
5 
9. 
Rosendal L, Langberg H, Skov-Jensen A, Kjaer M. Incidence of injury and physical performance adaptations 
6 
during military training. Clin J Sport Med 2003;13:157-63. 
7 
10. 
Knapik JJ, Jones SB, Darakjy S, et al. Injury rates and injury risk factors among U.S. Army wheel vehicle 
8 
mechanics. Mil Med 2007;172:988-96. 
9 
11. 
Almeida SA, Williams KM, Shaffer RA, Brodine SK. Epidemiological patterns of musculoskeletal injuries and 
0 
physical training. Med Sci Sports Exerc 1999;31:1176-82. 
1 
12. 
Rudzki SJ. Injuries in Australian Army recruits. Part II: Location and cause of injuries seen in recruits. Mil Med 
2 
1997;162:477-80. 
3 
13. 
Gironda RJ, Clark ME, Massengale JP, Walker RL. Pain among veterans of Operations Enduring Freedom and 
4 
Iraqi Freedom. Pain Med 2006;7:339-43. 
5 
14. 
M. S. National Analysis of Opioid Use Among Veterans. Phoenix, AZ2014. 
6 
15. 
Sullivan M. Study of Discontinuation of Chronic Opiod Therapy Among Veterans. Phoenix, AZ2014. 
7 
16. 
Konitzer LN, Fargo MV, Brininger TL, Lim Reed M. Association between back, neck, and upper extremity 
8 
musculoskeletal pain and the individual body armor. Journal of hand therapy : official journal of the American Society of 
9 
Hand Therapists 2008;21:143-8; quiz 9. 
0 
17. 
Reynolds KL, White JS, Knapik JJ, Witt CE, Amoroso PJ. Injuries and risk factors in a 100-mile (161-km) infantry 
1 
road march. Prev Med 1999;28:167-73. 
2 
18. 
Toblin RL, Quartana PJ, Riviere LA, Walper KC, Hoge CW. Chronic pain and opioid use in US soldiers after 
3 
combat deployment. JAMA internal medicine 2014;174:1400-1. 
4 
19. 
Rozet I, Nishio I, Robbertze R, Rotter D, Chansky H, Hernandez AV. Prolonged opioid use after knee arthroscopy 
5 
in military veterans. Anesth Analg 2014;119:454-9. 
6 
20. 
Jonas WB, Schoomaker EB. Pain and opioids in the military: we must do better. JAMA internal medicine 
7 
2014;174:1402-3. 
8 
21. 
Galanter M, Dermatis H, Sampson C. Narcotics anonymous: a comparison of military veterans and non-veterans. 
9 
Journal of addictive diseases 2014;33:187-95. 
0 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 16 of 18 
 
22. 
Dobscha SK, Morasco BJ, Duckart JP, Macey T, Deyo RA. Correlates of prescription opioid initiation and long-
1 
term opioid use in veterans with persistent pain. Clin J Pain 2013;29:102-8. 
2 
23. 
Von Korff M, Kolodny A, Deyo RA, Chou R. Long-term opioid therapy reconsidered. Ann Intern Med 
3 
2011;155:325-8. 
4 
24. 
Boscarino JA, Rukstalis MR, Hoffman SN, et al. Prevalence of prescription opioid-use disorder among chronic 
5 
pain patients: comparison of the DSM-5 vs. DSM-4 diagnostic criteria. Journal of addictive diseases 2011;30:185-94. 
6 
25. 
CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999-2008. : CDC; 2011. 
7 
26. 
Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for 
8 
responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance. Pain physician 2012;15:S67-116. 
9 
27. 
Trescot AM, Boswell MV, Atluri SL, et al. Opioid guidelines in the management of chronic non-cancer pain. Pain 
0 
physician 2006;9:1-39. 
1 
28. 
Manchikanti L, Helm S, 2nd, Fellows B, et al. Opioid epidemic in the United States. Pain physician 2012;15:ES9-
2 
38. 
3 
29. 
Administration SAaMHS. Substance abuse treatment admissions by primary substance of abuse, according to 
4 
sex, age group, race, and ethnicity 2009 (Treatment Episode Data Set): Substance Abuse and Mental Health Services 
5 
Administration. 
6 
30. 
Administration SAaMHS. Drug Abuse Warning Network: selected tables of national estimates of drug-related 
7 
emergency department visits. Rockville, MD: Center for Behavioral Health Statistics and Quality; 2010. 
8 
31. 
Administration SAaMHS. Results from the 2010 National Survey on Drug Use and Health: volume 1: summary of 
9 
national findings. Rockville, MD: Office of Applied Studies; 2011. 
0 
32. 
Gaskin DJ, Richard P. The economic costs of pain in the United States. The journal of pain : official journal of the 
1 
American Pain Society 2012;13:715-24. 
2 
33. 
Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? Journal of the 
3 
American Board of Family Medicine : JABFM 2009;22:62-8. 
4 
34. 
Deyo RA, Mirza SK. Trends and variations in the use of spine surgery. Clinical orthopaedics and related research 
5 
2006;443:139-46. 
6 
35. 
Taylor VM, Deyo RA, Cherkin DC, Kreuter W. Low back pain hospitalization. Recent United States trends and 
7 
regional variations. Spine 1994;19:1207-12; discussion 13. 
8 
36. 
Weinstein JN, Lurie JD, Olson PR, Bronner KK, Fisher ES. United States' trends and regional variations in lumbar 
9 
spine surgery: 1992-2003. Spine 2006;31:2707-14. 
0 
37. 
Cherkin DC, Deyo RA, Loeser JD, Bush T, Waddell G. An international comparison of back surgery rates. Spine 
1 
1994;19:1201-6. 
2 
38. 
Williamson E, White L, Rushton A. A survey of post-operative management for patients following first time lumbar 
3 
discectomy. Eur Spine J 2007;16:795-802. 
4 
39. 
Weiner BK, Dabbah M. Lateral lumbar disc herniations treated with a paraspinal approach: an independent 
5 
assessment of longer-term outcomes. J Spinal Disord Tech 2005;18:519-21. 
6 
40. 
Kotilainen E. Long-term outcome of patients suffering from clinical instability after microsurgical treatment of 
7 
lumbar disc herniation. Acta Neurochir (Wien) 1998;140:120-5. 
8 
41. 
Carragee EJ, Kim DH. A prospective analysis of magnetic resonance imaging findings in patients with sciatica 
9 
and lumbar disc herniation. Correlation of outcomes with disc fragment and canal morphology. Spine 1997;22:1650-60. 
0 
42. 
Andrews DW, Lavyne MH. Retrospective analysis of microsurgical and standard lumbar discectomy. Spine 
1 
1990;15:329-35. 
2 
43. 
Hakkinen A, Kautiainen H, Sintonen H, Ylinen J. Health related quality of life after lumbar disc surgery: a 
3 
prospective study of 145 patients. Disabil Rehabil 2005;27:94-100. 
4 
44. 
Carragee EJ, Han MY, Suen PW, Kim D. Clinical outcomes after lumbar discectomy for sciatica: the effects of 
5 
fragment type and anular competence. J Bone Joint Surg Am 2003;85-A:102-8. 
6 
45. 
Devin CJ, Lee DS, Armaghani SJ, et al. Approach to Pain Management in Chronic Opioid Users Undergoing 
7 
Orthopaedic Surgery. The Journal of the American Academy of Orthopaedic Surgeons 2014;22:614-22. 
8 
46. 
Walid MS, Hyer L, Ajjan M, Barth AC, Robinson JS, Jr. Prevalence of opioid dependence in spine surgery 
9 
patients and correlation with length of stay. Journal of opioid management 2007;3:127-8, 30-2. 
0 
47. 
Martell BA, O'Connor PG, Kerns RD, et al. Systematic review: opioid treatment for chronic back pain: prevalence, 
1 
efficacy, and association with addiction. Ann Intern Med 2007;146:116-27. 
2 
48. 
Deshpande A, Furlan A, Mailis-Gagnon A, Atlas S, Turk D. Opioids for chronic low-back pain. Cochrane Database 
3 
Syst Rev 2007:CD004959. 
4 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 17 of 18 
 
49. 
Eriksen J, Sjogren P, Bruera E, Ekholm O, Rasmussen NK. Critical issues on opioids in chronic non-cancer pain: 
5 
an epidemiological study. Pain 2006;125:172-9. 
6 
50. 
Lee D, Armaghani S, Archer KR, et al. Preoperative Opioid Use as a Predictor of Adverse Postoperative Self-
7 
Reported Outcomes in Patients Undergoing Spine Surgery. The Journal of bone and joint surgery American volume 
8 
2014;96:e89. 
9 
51. 
Wang M, Lozen AM, Erin E. Krebs, Laud PW, Nattinger AB. Predictors of 12-Month Opioid Use after Elective 
0 
Cervical Spine Surgery for Degenerative Changes.  North American Spine Society 28th Annual Meeting. New Orleans, 
1 
LA: The Spine Journal; 2013:6S-7S. 
2 
52. 
Chou R, Fanciullo GJ, Fine PG, Miaskowski C, Passik SD, Portenoy RK. Opioids for chronic noncancer pain: 
3 
prediction and identification of aberrant drug-related behaviors: a review of the evidence for an American Pain Society and 
4 
American Academy of Pain Medicine clinical practice guideline. The journal of pain : official journal of the American Pain 
5 
Society 2009;10:131-46. 
6 
53. 
Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic 
7 
noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain 
8 
Medicine clinical practice guideline. The journal of pain : official journal of the American Pain Society 2009;10:147-59. 
9 
54. 
Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. 
0 
Physiotherapy 1980;66:271-3. 
1 
55. 
Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the 
2 
Quebec Back Pain Disability Scale. Physical therapy 2001;81:776-88. 
3 
56. 
Jensen MP, Turner JA, Romano JM. What is the maximum number of levels needed in pain intensity 
4 
measurement? Pain 1994;58:387-92. 
5 
57. 
Deyo RA, Battie M, Beurskens AJ, et al. Outcome measures for low back pain research. A proposal for 
6 
standardized use. Spine 1998;23:2003-13. 
7 
58. 
Webster LR, Webster R.  Predicitng aberrant behaviors in Opioid-treated patients:  preliminary validation of the 
8 
Opioid risk too.  Pain Med. 2005; 6 (6): 432. 
 
9 
 
0 
59. 
Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. 
1 
Spine 2005;30:1331-4. 
2 
60. 
Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of 
3 
the Pain Catastrophizing Scale. Journal of behavioral medicine 1997;20:589-605. 
4 
61. 
Osman A, Barrios FX, Gutierrez PM, Kopper BA, Merrifield T, Grittmann L. The Pain Catastrophizing Scale: 
5 
further psychometric evaluation with adult samples. Journal of behavioral medicine 2000;23:351-65. 
6 
62. 
Buer N, Linton SJ. Fear-avoidance beliefs and catastrophizing: occurrence and risk factor in back pain and ADL in 
7 
the general population. Pain 2002;99:485-91. 
8 
63. 
Buysse D, Reynolds C, Monk T, Berman S, Kupfer D.  The Pittsburg Sleep Quality Index:  A New Instrument for 
9 
Psychiatric Practice and Research.  Psychiatry Res 1988; 28:  193-213. 
0 
64. 
O'Donoghue GM, Fox N, Heneghan C, Hurley DA. Objective and subjective assessment of sleep in chronic low 
1 
back pain patients compared with healthy age and gender matched controls: a pilot study. BMC musculoskeletal disorders 
2 
2009;10:122. 
3 
65. 
Marty M, Rozenberg S, Duplan B, Thomas P, Duquesnoy B, Allaert F. Quality of sleep in patients with chronic low 
4 
back pain: a case-control study. Eur Spine J 2008;17:839-44. 
5 
66. 
Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and 
6 
the role of fear-avoidance beliefs in chronic low back pain and disability. Pain 1993;52:157-68. 
7 
67. 
Jacob T, Baras M, Zeev A, Epstein L. Low back pain: reliability of a set of pain measurement tools. Arch Phys 
8 
Med Rehabil 2001;82:735-42. 
9 
68. 
Crombez G, Vlaeyen JW, Heuts PH, Lysens R. Pain-related fear is more disabling than pain itself: evidence on 
0 
the role of pain-related fear in chronic back pain disability. Pain 1999;80:329-39. 
1 
69. 
Fritz JM, George SZ, Delitto A. The role of fear-avoidance beliefs in acute low back pain: relationships with 
2 
current and future disability and work status. Pain 2001;94:7-15. 
3 
70. 
Fritz JM, George SZ. Identifying psychosocial variables in patients with acute work-related low back pain: the 
4 
importance of fear-avoidance beliefs. Physical therapy 2002;82:973-83. 
5 
71. 
George SZ, Stryker SE. Fear-avoidance beliefs and clinical outcomes for patients seeking outpatient physical 
6 
therapy for musculoskeletal pain conditions. J Orthop Sports Phys Ther 2011;41:249-59. 
7 
72. 
Childs JD, Fritz JM, Flynn TW, et al. A clinical prediction rule to identify patients with low back pain most likely to 
8 
benefit from spinal manipulation: a validation study. Ann Intern Med 2004;141:920-8. 
9 

The Effect of a Pain Medication Educational Approach before Lumbar Surgery on 6-month Post-Operative Use 
of Opioid Medication: A Randomized Clinical Trial. 
Version 8, 10 April 2018   
 
 
Form P2 - Version 2.2, 5 March 2013 
 
Page 18 of 18 
 
73. 
Fritz JM, Delitto A, Erhard RE. Comparison of classification-based physical therapy with therapy based on clinical 
0 
practice guidelines for patients with acute low back pain: a randomized clinical trial. Spine 2003;28:1363-71. 
1 
74. 
Brennan GP, Fritz JM, Hunter SJ, Thackeray A, Delitto A, Erhard RE. Identifying subgroups of patients with 
2 
acute/subacute "nonspecific" low back pain: results of a randomized clinical trial. Spine 2006;31:623-31. 
3 
75. Faour M, Anderson JT, Ahn NU Prolonged Preoperative Opioid Therapy Associated with Poor Return to Work Rates 
4 
after Single-Level CervicalFusion for Radiculopathy for Patients Receiving Workers' Compensation Benefits. Spine (Phila 
5 
Pa 1976). 2016 May 24. [Epub ahead of print] 
6 
76, Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol 
7 
Ther. 1991;14(7):409–415. 
8 
77. McCarthy MJ, Grevitt MP, Silcocks P, Hobbs G (2007) The reliability of the Vernon and Mior neck disability index, and 
9 
its validity compared with the short form-36 health survey questionnaire. Eur Spine J16: 2111–2117 
0 
78. Auffinger BM1, Lall RR, Dahdaleh NS, Wong AP, Measuring surgical outcomes in cervical spondylotic myelopathy 
1 
patients undergoing anterior cervical discectomy and fusion: assessment of minimum clinically important difference. PLoS 
2 
One. 2013 Jun 24;8(6):e67408. 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
0 
 
1 
13.0  TIME REQUIRED TO COMPLETE THE RESEARCH (including data analysis).  
2 
With an anticipated surgical lumbar surgery load of approximately 20-25 patients per month and a conservative enrollment 
3 
rate of 50%, we anticipate 1 year for the enrollment period. 
4 
 
5 
• 
December 2014 – Protocol submitted to BAMC IRB 
6 
• 
April 2015 – Anticipate IRB approval 
7 
• 
March – April  2015 – Study staff training on study procedures 
8 
• 
May 2015 – Subject recruitment/enrollment begins 
9 
• 
May 2017 – Subject recruitment/enrollment end 
0 
• 
November 2017 – Last subject completes 6-month follow-up 
1 
• 
November 2017 – Healthcare utilization data requested from PASBA 
2 
• 
May 2018 – Data analysis and sub-analysis complete 
3 
• 
August 2018 – Publication submitted to appropriate journal 
4 
 
5 
   
6 
14.0  STUDY CLOSURE PROCEDURES   
7 
After all aims have been met, the PI will submit a protocol closure report through IRBNet.  Study files will be kept 
8 
for 6 years and then destroyed.   
9 
 
0 
APPENDICES: 
1 
A. Oswestry Disability Index (OSW):  
2 
B. Numeric Pain Rating Scale (NPRS):  
3 
C. Pain Catastrophizing Scale (PCS):  
4 
D.The Pittsburg Sleep Quality Index (PSQI):   
5 
E. Fear Avoidance Belief Questionnaire (FABQ):  
6 
F.  Opioid Risk Tool 
7 
 
8