Running Header: EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 1

Differentiation in quality of life for minimally invasive decompression versus laminectomy

surgery on lumbar stenosis

Michael Frabotta, Joseph Gorospe, Jeffrey Harper, Samuel Kooyman and Bradley Woodley

04/05/2019

Nursing: 3749: Nursing Research

Dr. Kim Ballone

EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 2

Abstract

The purpose of this research was to investigate the effect of lumbar stenosis surgery on

quality of life. Therefore, a comparison was drafted between minimally invasive and

laminectomy surgery in order to draw conclusions. In looking at quality of life, a few factors

were considered such as pain, financial status, mobility and overall satisfaction post operation.

The information in this research was applied from a self pilot study along with five professional

scholastic journals. In doing so, it was discovered that there was insignificant evidence to support

one surgery versus the other. On the other hand, it was found that quality of life as a whole

approved following spinal operations for lumbar stenosis and gives insight to nurses on quality

care. Although there was slight variation between the two procedures, no concrete conclusions

could be drawn to favor one over another. Overall, the conducted research showed that there is

improvement in quality of life following surgery and has opened the door for other researchers to

use this study as a stepping stone in further experimentation.

Effect of lumbar stenosis surgery on quality of life

Key words

Minimally invasive spinal surgery, laminectomy, Oswestry disability index, lumbar

stenosis, quality of life, quality-adjusted life year, visual analogue scale and orthopedics.

Abbreviations

QOL- Quality of life. RTD- Return to duty. MIS- Minimally invasive surgery. ODI-

Oswestry disability index. HIPAA- Health insurance portability and accountability act. VAS-

Visual analogue scale. SF-36- Short form 36. QALY- Quality adjusted life year. GLWACH-

General Leonard Wood army community hospital.

EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 3

Literature Review

Introduction

The importance of this research in regard to nursing care is imperative due to being a

patient advocate. By having clinical insight on that matter at hand, nurses will be able to evaluate

outcomes and have a better understanding of the subject matter. Hence, the information gathered

through the Maag library, JSTOR and EBSCO host allowed for five sources to be reviewed and

data collection to occur. These findings focused primarily on patient quality of life and surgical

procedure outcomes by evaluation through various methods. With the findings, pain ratings,

patient quality of life, financial impact and implications for future use will be discussed.

To start, there has been continuous development in the field of orthopedics since the

dawn of corrective surgery. Today it is more imperative than ever to focus on a patient's quality

of life before and following operation. Nonetheless, spinal surgery is the pinnacle of scrutiny due

to the lack of understanding on the term pain. Since operative techniques change every few

years, it is critical to identify the quality put into minimally invasive and laminectomy surgery.

Any procedure takes a great deal of time to analyze before the first incision is made, and doctors

and nurses can help to make informed decisions with reliable research on the matter. Therefore,

understanding what surgery leads to the best results is among a top concern for all patients facing

the arduous decision of undergoing spinal surgery. Minimally invasive surgery (MIS), invasive

surgery, and epidurals tend to be among the top contenders for back pain. Health professionals

are at a standstill when it comes to deciding the best procedure for everyone they meet. Also,

considering the quality of life after surgery in relation to pain and future expenses is a matter

hardly considered. Therefore, patients undergoing back surgery should consider all possible

procedures, and evaluate which will lead to the best quality of life following operation.
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 4

For those experiencing chronic back pain and lumbar stenosis, a variety of different

invasive and non-invasive surgeries are available to aid discomfort. Orthopedic practice includes

knowing how to conduct MIS and open surgeries on any part of the body. In fact,

“Approximately 70% to 85% of all adults will be affected by low back pain…” (Lunsford et al.,

2016, p. 572) resulting in some sort of medical attention. Not all pain requires surgery, but with a

high percentage of the population experiencing back abnormalities calls into question the quality

of operations. The two main corrective techniques practiced by orthopedic surgeons are MIS and

laminectomy surgery. Constant analysis is being collected to determine which procedures fit best

with each specific case. In agreement with precise and sterile surgery are doctors Turel, Kerlous,

and Deutch who acclaim that, “Minimally invasive spine surgery (MIS) allows for reduction in

blood loss, length of stay, recovery time, and complications” (2017, p. 39). The overall

conclusions of MIS contribute to quality of life post-surgery. On the other hand, a plethora of

research claims to target MIS as unfit, and more destructive on a patient's wellbeing. Doctor

Epstein states that, “MIS lumbar surgery resulted in a higher incidence of root injuries,

radiculitis, or plexopathy versus open lumbar surgical techniques” (2016, p. 1). The debate falls

primarily on a per patient basis in recognizing the benefits and consequences of either outcome.

Both surgeries offer a variety of different approaches, and it is critical to pinpoint what works

and what does not.

In reference, failed spinal surgery can lead to more hardships than just continuous

physical pain. In most cases patients rank their pain level on a scale, or it is expressed in side

terms by medical professionals. This tactic does not however correlate to what hardships every

family face in the case of unsuccessful surgery. Many outside factors such as costs, discomfort,

and quality of life are not recorded for qualitative and quantitative studies. Therefore, it has been
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 5

expressed by civilian and military personnel alike that returning to work after such an operation

highly depends upon one’s status in the workplace. The research conducted by officers in the

military found that “...higher rank and single-level procedures were associated with higher RTD

rates” (Lunsford, Lawson, Johnson, & Topp, 2016, p. 574) which indicates prestige over stress.

Hence, pain can be overlooked, but accumulating costs and a poor lifestyle are a constant

shadow. The tasks conducted look to express follow up care in relation to quality of life

following both MIS and laminectomy surgery. Little rebuttal is offered for cost effective

operations, but MIS research supports little postoperative complications. Conclusive research on

minimal operative procedures found that “...MIS surgery techniques are safe and efficacious,

reduce pain dramatically, and provide a high yield culture” (Turel et al., 2017, p. 43) in sum with

quality of life. As a result, failed spinal surgery does bring about complications that go

undocumented due to a lack of quantitative data on the matter.

Having patients express an ideal lifestyle post-surgery is a major implication on how they

expect life to change. However, not all expectations are expressed freely, or with dominant

truths. Many health professionals and nurses alike do not fully understand the extent of post-

surgical care due to the constant onslaught of new patients rolling in for checkups. That

ignorance leads to a variety of different outcomes based on the type of surgery, and on adequate

communication between workers and clients. It is the responsibility of the nurses to act as a

middle man in conveying understanding for the care a patient receives. All operations involve

risk, but the quality of one’s life following surgery is not isolated from problems arising. For

instance, doctors Kamper et al. state that, “Sciatica due to lumbar disc herniation is responsible

for considerable personal and societal costs” (2014, p. 1021). These added expenditures are not

budgeted for, and cause conundrums to people’s everyday lives. To combat the negative
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 6

outcomes, “Pain reduction and improved function in daily activities should be the aim of these

programs” (Rhodin, 2014, p. 168) which undertake life changing responsibilities. With an

improvement in quality of life many problematic variables will be eliminated from concern.

Therefore, the matter at hand revolves around the idea that spinal surgery may not be as

practical as orthopedic experts expect it to be. A broad analysis of other detailed research on

spinal surgeries has left imperative material unanswered. None more fitting than the gap on why

lumbar stenosis surgery is not fully effective. After having established ground for further

research, it is of great benefit to ask what the effect of lumbar stenosis surgery on quality of life

is. In looking at various research studies that correlate with defining whether one option is better

than another has brought about one specific analysis that masks a self pilot study. Hence, using

recorded data from multiple scholars has led to a primary method to compare and contrast

findings.

Methods

The study is a meta-analysis qualitative case study with multicenter observation. All

patients studied from five different sources were subjected for lumbar spine surgery in

orthopedic departments from March 2005 to December 2017. A total of 1,373 patients

participated, 818 males and 555 females, of the mean age of 66. The Health Insurance Portability

and Accountability Act (HIPAA) was not breached, and patients opted to participate for research

purposes. Patients that underwent lumbar spinal decompression and had lumbar stenosis were

selected for the research. 453 of the male patients and 289 females chose to undergo

laminectomy surgery. The other 365 males and 266 females elected to partake in a MIS in hopes

to reduce the extent of surgical operations. Over 1,972 eligible candidates that did not give

consent and who did not meet the research guidelines were not considered for the study but acted
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 7

in place of a no effect group. The Oswestry disability index questionnaire was used to score the

condition of the patient’s disabilities. The scores of the index range from 0 to 50, where 0 means

no disability and 50 being max disability. Upon completion of the surgery and survey following

the procedures, a 2 through 24 month gap was allowed before a final follow-up for review. In

correlation, a small pilot study was also conducted at Fort Leonard Wood hospital between the

dates of March 24, 2017 to April 7, 2017. A total of eight patients participated, six males and two

females, of the age 41 and older. Two of the male patients and one female elected to partake in

open spine surgery. The other five patients chose MIS based on personal preference.

Procedure

Patients fitting the conditions of the research gave informed consent on the matter and

gave information freely. Data was collected through various orthopedic registries and direct

observation which were used for quality control and research. The pilot study was approved by

medical director Captain Gregg and human relations at General Leonard Wood Army

Community Hospital. All research journals used a combination of a visual analogue scale (VAS),

Oswestry disability index (ODI) and short form-36 (SF-36) which were completed by each

patient before and directly following surgery, and a few months later for clinical use in the

primary sources. In addition, there was a review of X-ray scans, and suggested recovery time for

each patient. Time of recovery focused primarily on the intensity of pain expressed over time.

After all, researchers Perneros, Tropp, and Sandqvist also found that, “Pain is always a

subjective phenomenon” (2014, p. 69). An account for bias is recorded in results for a ± rating of

1.2 on pain intensity (VAS). Also, a plus negative rating of estimated expenditures for 1,500

dollars was formulated. All other partial discrepancies were isolated and corrected before

dismissal of participants in the pilot study. The use of statistical analysis was performed to
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 8

interpret P values in the population for those in the observational database research articles. It

was determined that a 10 point or less change in the Oswestry disability index reflected no

change, but any value of 10 or greater showed some significance. In looking at the populations, a

change of 0.8 or more is considered a substantial factor in how quality of life changed in the

patient’s population. Therefore, the surgical procedure aimed towards influencing those values

are the laminectomy and MIS. According to researchers, “When a laminectomy is performed, the

spinous process and the laminas of the involved levels as well as the medial aspects of the facet

joints are resected” (Nerland et al., 2015, p. 3). On the other hand, micro decompression occurs

through small skin incisions and allows for some ligaments to remain intact unlike the

laminectomy. All matters considered, variables in the final reporting and matched cohort data

allowed for statistical material to be gained.

Measures

The baseline data collected in this research focuses on the ODI, VAS, SF-36 and includes

patients age, sex, employment status (currently working or retired), and symptoms. A collection

of post-surgical data involving pain intensity level, quality of life, remaining cost, and improved

versus unimproved patients allowed for comparison. A standard deviation does apply to the

collected data with no errors in reporting. Scales of measurement for pain ranged from one to ten

for both physical and psychological for the pilot study. Other recordable quantitative data falls

into an approach on nursing care and quality of life in application for the study. To gain precise

measures, related questions were stated differently to promote what should have been the same

response. The sum of information gathered was computed in chart form to access the role of

which surgery led to the best results.

EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 9

Hypothesis

The focus is to understand the underlying changes in QOL from pre to post surgery.

Although studies have shown that many patients display a relief in leg and other chronic pains,

back pain tends to linger in post observation. Clinical observations do not consider the QOL in

the weeks following the operation. Therefore, it is hypothesized that patients who underwent

MIS will experience fewer financial difficulties, and quicker rebound time then those who

elected to undergo laminectomy. The improved group versus the no-effect group will display

data fitting for varying domains from pre to post surgery. To add, it is also predicted that the two

patient groups will experience value differences over time due to the functions of the surgical

outcomes in the individuals.

Data Analysis

The data was analyzed through graphs and P values per case with mixed linear models

based on professional standard statistical analysis. First, information collected from the patients

was categorized as either MIS or laminectomy surgery. Additionally, notes collected in the field

were applied to the categories in order to determine what approach had the best pay off. The case

study conducted displays a broad amount of correlative data in determining the most ethical

approach for everyone. In relation to other credible sources, the data was compared, and a

consensus identifying the best surgical approach was determined.

Results

This meta-analysis study focused on patients undergoing corrective spinal surgery either

through the means of MIS or open spine operations. A total of 1,373 patients were interviewed,

with various background histories. From the research articles, 88% of patients completed a final

review. As for the pilot study, all participants gave final opinions. All clients expressed either a
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 10

need for decompression surgery or for lumbar stenosis surgery. In a brief survey, most patients

reported using some sort of pain medication to aid in preoperative and postoperative recovery.

The bodily pain in most patients decreased because of successful surgeries.

Most of the sample expressed back pain improvement as shown in the clinical analysis

charting and in the precipitated complications following the event. The mean amounts for pain in

MIS and laminectomy surgery were recorded both prior to and after surgeries. For MIS and open

spine pre-analysis surveys, the averages were relatively similar which is to be expected. MIS

patients had an overall pre-surgical analysis screening rate of (62%) with a P value of 0.317 for

the severity of their stenosis going into surgery based on QOL index questionnaires. On the flip

side, laminectomy surgery patients expressed an overall pre-analysis rating of (60%) P value of

0.324. Therefore, all patients were at a consensus on how they felt before operative procedures

took place. A varying in the research percentage is (32%) or (-8 to 8) for the Oswestry disability

index on expressed claims by each participant.

Clinical data gathered after operation shows that MIS and laminectomy spine participants

increased satisfaction ratings after successful surgeries. The data gathered shows a post clinical

analysis rating of (70.5%) with bodily pain excluded for data purposes. For the Oswestry

disability index the baseline was 40 and at a few months postoperative follow up it was 22.2 with

a P value of <0.001. There was a gain of (36%) satisfaction in health and functioning. Body pain

also decreased to a graded level of (3/10) from (7/10) and in the linear model displayed a 42%

change. MIS showed to remain the same or increase patient satisfaction in every field of

recordable data.

The clinical data gathered after operation for patients undergoing laminectomy surgery

also increased in overall ratings. The data for post clinical analysis rating is (67.5%) with bodily
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 11

pain excluded. The Oswestry disability index baseline was 42 and a few months changed to 25.3

with a P value of <0.001. In comparison with pre-analysis studies, an increase of (34%)

satisfaction rating occurred. Body pain decreased to a graded level of (3/10) from (8/10) and in

the linear model displayed a 37.5% change. Laminectomy surgery displayed stagnant or an

increase change in patient satisfaction in all recordable fields.

A pivotal factor in determining which operation fit the participants best was cost

effectiveness. The cost of surgery for MIS compared with laminectomy surgery before insurance

application is grossly different. In asking participants for apparent cost for surgery alone, the out

of pocket costs vary. Therefore, cost effectiveness in correlation with the use of a quality-

adjusted life year (QALY) analysis was used to see which procedure offered the most benefit in

terms of dollars spent. The QALY allows for total cost of operation and post-surgical expenses to

be factored into overall rating of life years gained from surgery. It is a measure which multiplies

life years along with the quality of the life years. The calculation relied on utility values ranging

from 0 (Dead) to 1 (Perfect health). The baseline value for patients who receive no surgical

procedure from back pain ranges around 6 years for management care; with an estimated

satisfaction score of (21%). This no effect group also has a factored in cost of both societal and

medical interventions that accumulates to about ($133,640) for the six years. In MIS, the mean

total for the operation is around ($69,403) for QALY after two years, whereas in laminectomy it

is ($77,800). An estimated bias plus minus factor in conclusion of expense for both cases is (±

$1,500). By using the variation in expenditures and success of the operation it is possible to

calculate a score for each surgical outcome. By using the QAYL algorithm it is shown that

(1.338) gained per QALY for MIS and (1.142) gained per QALY for laminectomy. In looking at

a positive response to surgery based on surgical outcome, there is an impressive change in QOL.
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 12

Hence, for MIS it is calculated the value is ($51,870) in reference to cost effectiveness by using

satisfaction scoring and total cost for QALY. On the other hand, laminectomy was figured to be

($68,126) for its cost effectiveness. In looking at the cost variation on a per patient basis, little

significant value is deemed from the findings.

Quality of life is imperative in deciding whether to undergo surgery. In a post operation

analysis questionnaire, patients expressed on a scale of (0-100) the quality of life they expect to

have following operation. For the MIS participants, a mean rating of (77.4%) was recorded for

all principals of life after surgery. The laminectomy group had recorded ratings of (67.6%) for

QOL after surgery. These values include patient bias due to personal preference and are subject

for further analysis in the months following the operation. Age factor and sex also plays part in

patients and may be different for those of a younger age.

In conclusion of the data gathered, the relative importance of this research evaluated

relationships between MIS and laminectomy surgery in relation to QOL. For costs after surgery

and overall improvement, there were partial differences between the two measures observed.

There were also noticeable value changes from pre to post surgery in patient self-analysis.

Statistical data gave lead for clinical analysis observation in all patients who underwent

orthopedic care. In all, data changes support the claim of improvement after spinal surgery.

Discussion

The results suggest that there was an insignificant difference between MIS and

laminectomy surgery in mean reported levels of pain, costs, and quality of life pre and post-

operation. The importance of the analysis suggests that patients in the MIS group were prone to

express an increased role in functioning due to bodily pain decrease, expenditures, and

successful operations. The invasive operative group also expressed an increase in functioning
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 13

due to successful surgery, but QOL varies due to financial state and patient age. With an overall

basis of good surgical outcomes, the patients expressed a new emphasis on life with apparent

relief of some chronic pain. Not only did physical pain improve, but other factors such as

emotional health and bodily functioning were quantified to have increased. The results display

improvement in both surgeries on a per patient basis. Whereas, expressions of physical pain and

QOL do reflect bias, but financial state is measured accordingly. Overall, there is slight

difference in the clinical outcomes between MIS and laminectomy surgery in relation to the

observed first look of pain reduction.

This study is acting upon other similar research conducted in the field to determine QOL

in relation to MIS and open spinal surgery. Using this new-found application for research has

allowed for focus on quality of life because of surgical outcomes and plays into nursing care

based on their professional roles. The two methods in the data suggest that there are inter-

correlations in the variance of rank in the data. The results for both the MIS and invasive

surgeries are not high enough to be considered unreliable or problematic on account for surgical

outcome. The value changes show an altered state of comparison from pre to post surgery to

support claims of surgical importance. All things considered, there is “... significant need for

ongoing care and support for patients undergoing spinal surgery” (Davis, Vincent, Henley, and

Mcgregor, 2013, p. 136). A few patients expressed an uncertainty heading into surgery, but with

a general understanding of the procedure their doubts diminished. With support after operation,

the participants all express an expected improvement in QOL in the coming months.

Therefore, in collaboration with other clinical research studies it is evident that certain

aspects after surgery are similar. Although the corrective procedures may be successful in

numbing some pain, a few patients still expressed a discomfort that lingered after surgery. In
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 14

both groups, the chronic pain sensation was primarily eliminated in daily functioning, but

physical pain was still a concern. In comparison with doctors Schwartz, Sajobi, Lix, Quaranto,

and Finkelstein research, “These finding suggest that among improved patients, bodily pain is

primarily reflective of physical item response post-surgery…” (2013, p. 2261). A moderate

follow-up on patient’s pain index shows a change of (52%) from pre to post surgery. It is

recognized that pain is specific for everyone, and data should not be used for cumulative research

due to bias gaps. Not only was pain decrease an important part of research, but so was cost

effectiveness.

A correlation between surgery and cost was a pivotal factor in deciding what surgery the

patients chose to undergo. There was a partial difference in cost between MIS and laminectomy.

Also, the expected recovery time varied from only a few hours to days for MIS. On the other

hand, open spine surgery recovery time was expected to take up to six or more weeks. However,

in this study and others, “Cost-effectiveness or cost-utility ratios do not themselves provide

information on the efficiency of treatments” (Zucco et al., 2015, p. 274). Post-surgical outcomes

for both studied groups show that treatment was successful in stagnation or improving all fields

of study. In relation, the MIS however, does provide the best QALY for patients on a tight

budget and wanting quick recovery time.

Additional research should be conducted to get a better understanding on all variations in

the research. With all subject matter recorded into quantitative and qualitative data, further

research can build upon the information. Although the study conducted gave insight on MIS and

laminectomy surgery outcomes, it failed to answer which surgery led to the best QOL in data

terms. A gap that remains in the field of research is determining whether surgery is really needed

to relieve chronic back pain.

EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 15

Limitations

The limitations in this research include a scant number of similar articles, questionnaires

and possible response bias. Additional research on the matter should look to study a wider range

of patients and include a more detailed analysis. If bias influences could be adjusted, then there

could be conclusive evidence on pain. Also, informed consent by the patient may influence

truthfulness in responses to questions. This is due to possible scrutiny if not praising the surgeon

for a successful surgical outcome. Hence, to maximize the efficiency of the research study, one

should take advances in determining the best surgical procedure on a per patient basis.

In sum, the results suggest that all patients showed a notable change in their QOL from

pre to post surgery. Body pain seems to improve in both surgical procedures, but further research

on the topic is imperative for clinical insight. Overall, these results lay claim for an established

ground for more detailed research.

Acknowledgements

Acknowledgements are to be made to GLWACH for allowing for a facility to aid in the

research. Medical director captain Gregg for making accommodations for the work, and all

patients that graciously gave up their time to partake in the small pilot study to act as a primary

comparison.

References
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 16

Davis, R. E., Vincent, C., Henley, A., & Mcgregor, A. (2013). Exploring the care experience of

patients undergoing spinal surgery: a qualitative study. Journal Of Evaluation In

Clinical Practice, 19(1), 132-138. doi:10.1111/j.1365-2753.2011.01783.x

Epstein, N. E. (2016). More nerve root injuries occur with minimally invasive lumbar surgery,

especially extreme lateral interbody fusion: A review. Surgical Neurology

International, 7(Suppl 3), 1-10. doi:10.4103/21527806.174895

Geurts, J. W., Willems, P. C., Kallewaard, J., Van Kleef, M., & Dirksen, C. (2018, October 01).

The Impact of Chronic Discogenic Low Back Pain: Costs and Patients' Burden.

Retrieved April 01, 2019, from

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6188764/

Kamper, S., Ostelo, R., Rubinstein, S., Nellensteijn, J., Peul, W., Arts, M., & Tulder, M. (2014).

Minimally invasive surgery for lumbar disc herniation: a systematic review and

meta-analysis. European Spine Journal, 23(5), 1021-1043.

doi:10.1007/s00586-013-3161-2

Lunsford, J. G., Lawson, B. K., Johnson, A. E., & Topp, R. F. (2016). Return to Duty Rates in

Active Duty Service Members After Elective Surgery of the Lumbar Spine.

Military Medicine, 181(6), 572-576. doi:10.7205/MILMED-D-15-00216

Nerland, U., Jakola, A., Solheim, O., Weber, C., Rao, V., Lønne, G., . . . Gulati, S. (2015).

Minimally invasive decompression versus open laminectomy for central stenosis

of the lumbar spine: Pragmatic comparative effectiveness study. BMJ: British Medical

Journal, 350. Retrieved from https://www.jstor.org/stable/26520472

Perneros, G., Tropp, H., & Sandqvist, J. (2014). Evaluation of occupational performance and

pain intensity: before and after back surgery and rehabilitation. Scandinavian
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Journal Of Occupational Therapy, 21(1), 69-81. doi:10.3109/11038128.2013.862296

Rhodin, A. (2014). A Case of Severe Low Back Pain After Surgery. Journal Of Pain &

Palliative Care Pharmacotherapy, 28(2), 167-169.

doi:10.3109/15360288.2014.911796

Schwartz, C. E., Sajobi, T. T., Lix, L. M., Quaranto, B. R., & Finkelstein, J. A. (2013). Changing

values, changing outcomes: the influence of reprioritization response shift on

outcome assessment after spine surgery. Quality Of Life Research, 22(9), 2255-

2264. doi:10.1007/s11136-013-0377-x

Turel, M. K., Kerolus, M., & Deutsch, H. (2017). The role of minimally invasive spine

surgery in the management of pyogenic spinal discitis. Journal Of

Craniovertebral Junction & Spine, 8(1), 39-43. doi:10.4103/0974-8237.199873

Zucco, F., Ciampichini, R., Lavano, A., Costantini, A., De Rose, M., Poli, P., & ... Mantovani, L.

G. (2015). Cost-Effectiveness and Cost-Utility Analysis of Spinal Cord

Stimulation in Patients With Failed Back Surgery Syndrome: Results From the

PRECISE Study. Neuromodulation, 18(4), 266-276. doi:10.1111/ner.12292

EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 18

Appendix

Informed Consent
Research Subject Informed Consent Form

Prospective Research Subject: Read this consent form carefully and ask any questions
you would like before you decide to partake in the research study. You are free to ask
questions at any time, before, during and after participation in the research.

Project Information:

Project Title: Effect of lumbar stenosis Host Organization: General Leonard

surgery on quality of life Wood Army Community Hospital

Principal Investigator: Sam Kooyman Phone: 330-397-4499

Purpose of Research Study:

- To determine through qualitative and quantitative research the best approach to
surgery. Determine which procedures, if any, lead to the best quality of life post
operation. Lastly, establish ground for further research in the field of orthopedic
surgery.

Procedure:
- You will be asked to answer a variety of different qualitative and quantitative
research question based on the surgery, finance, experience, and other surgical
related question.
- Expected length of the research is to be approximately two weeks in sum.
- Monitoring status will be in two meetings. One will take place in the day
following surgery, and the day before release or conclusion of study.

Possible Risk of Discomfort:

- No known risks are associated with this research study. Any questions that make
the patient feel uncomfortable are not to be disclosed.

Ownership of Documentation:
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 19

- All subject matter gathered will be put into chart form for conclusive analysis on
each procedure. Names will not be shared, and privacy matters are safe without
subject to change.

Possible Benefits:
- Benefits to participants are not stated, but for the general public, they will get a
better understanding on the surgical procedures and QOL after surgery.

Confidentiality:
- Your identity in this study will be treated as confidential. The results of this study
may be published for scientific purposes and will not give your name or other
references.

Termination of Study:
- You are free to choose whether to participate in this study. At a wish to cease
participation in the study please contact the following:
● Please notify Sam Kooyman (330-397-4499) of your decision.

Authorization:
- I have read and understand this consent form and am voluntarily deciding to
participate in this research study. I also understand that nothing in this form
outplays any federal, state, or other lawful acts for my privacy.

Participant Name:
Date:

Signature of Participant:
Date:

Investigator Name:
Date:

Signature of Investigator:
Date:
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 20

Visual Analogue Scale (VAS)

Instructions for producing a VAS Bedside card:

OPTION 1
• Double-sided print or photocopy the next 2 diagrams ensuring that the lines are
exactly 10 cm in length and superimposed
• Laminate the VAS Bedside card for patient use

PLEASE NOTE: For purposes of double-sided print, the numbers on this

scale are reversed.

OPTION 2
• Print or photocopy the next 2 diagrams on an A4 sheet ensuring that the lines are
exactly 10 cm in length
• Fold at the dotted line
• Do not show the patient the numbered scale
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 21

Numerical rating scale (NRS)

Faces rating scale (FRS)

Pain rating scales instructions

EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 22

Subjective pain score

All patients are to have a functional activity score recorded in addition to the chosen
subjective score.

Visual analogue scale (VAS)

Instruct the patient to point to the position on the line between the faces to indicate how
much pain they are currently feeling. The far-left end indicates "no pain" and the far-
right end indicates "worst pain ever."

Numerical rating scale (NRS)

Instruct the patient to choose a number from 0 to 10 that best describes their current
pain. 0 would mean "no pain" and 10 would mean "worst possible pain."

Faces rating scale (FRS)

Adults who have difficulty using the numbers on the visual/numerical rating scales can
be assisted with the use of the 6 facial expressions suggesting various pain intensities.
Ask the patient to choose the face that best describes how they feel. The far-left face
indicates "no hurt" and the far-right face indicates "hurts worst." Document number
below the face chosen.

Behavioral rating scale

The behavioral pain assessment scale is designed for use with nonverbal patients unable
to provide self-reports of pain.

• Rate each of the 5 measurement categories (0, 1, or 2).

• Add these together.
• Document the total pain score out of 10.

Functional activity score

This is an activity-related score. Ask your patient to perform an activity related to their
painful area (for example, deep breath and cough for thoracic injury or move affected
leg for lower limb pain).

A – No limitation meaning the patient’s activity is unrestricted by pain

B – Mild limitation means the patient’s activity is mild to moderately restricted by pain
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 23

C - Severe limitation means the patient ability to perform the activity is severely limited
by pain

*Relative to baseline refers to any restriction above any preexisting condition the patient
may already have.

Variable No Effect Laminectomy MIS

Pain (VAS) 8.9 3.3 2.9
Activity 0.34 0.65 0.69
Oswestry 40.0 25.3 22.2
Satisfaction 21% 67% 77%
Male 1,132 453 365
Female 840 289 266
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 24

Age 64.2 69.6 67.3

Oswestry
50

45

40

35
Laminectomy
Mean ODI Score

30 Linear (Laminectomy)
25 MIS
Linear (MIS)
20 No Effect
Linear (No Effect)
15

10

0
0.8 1 1.2 Baseline
1.4 1.6 1.812 Months
2 2.2
Follow Up
EFFECT OF LUMBAR STENOSIS SURGERY ON QUALITY OF LIFE 25