Assessment and Alleviation of Lumbopelvic Pain and Pelvic Floor Dysfunction
Abstract
Because of the time- and labor-intensive nature of the proposed
study, a 5-week pilot test consisting of 10 subjects was implemented to
determine if protocol modifications were necessary and if the full
60-subject study was warranted.
Abbreviations: Abbreviations: LBP: Low Back Pain; PFD: Pelvic Floor Disorders; PFM: Pelvic Floor Muscles; IRB: Institutional Review Board
Introduction
Low back pain (LBP) is a condition of localized pain to the lumbar
spine whose etiology is commonly unknown [1]. Pelvic floor disorders
(PFD) occur when the muscles that comprise the pelvic floor fail to
properly contract. This can cause urinary incontinence, pelvic organ
prolapse, fecal incontinence, or other sensory and emptying
abnormalities of the lower urinary and GI tracts [2]. Current evidence
shows that individuals with low back pain have a significant decrease in
pelvic floor function compared to individuals without LBP [3]. Over 25%
of all women and more than a third over the age of 65 experience PFD.
Even though it is a physiological problem, the psychosocial impact of
PFD can be much more detrimental to the patient's quality of life. Over
the next 30 years chronic health problems associated with PFD are
projected to increase by 50% due to the increasing numbers of women
reaching age 65 [4]. PFD does not typically have one specific cause.
Pregnancy/childbirth, age, hormonal changes, obesity, lower UTI, and
pelvic surgery are major risk factors. Additionally, anatomical,
physiological, genetic, reproductive and lifestyle components are
probably PFD developmental influences [1,4].
The pelvic floor forms the inferior border of the abdomino- pelvic cavity [4].
It supports the abdomino-pelvic organs. The pelvic floor muscles
(PFM) function as a unit instead of individually contracting. They play
an important role in maintaining and increasing intra-abdominal pressure
during functional tasks such as lifting, sneezing, coughing, and
laughing to prevent urinary and fecal incontinence [3,5]. Men can also
have disorders of the pelvic floor, however due the anatomy of the male
pelvis, it is less common [6]. Current evidence supports exercise
protocol with the common goal of regaining neuromuscular control of the
pelvic floor and deep abdominal muscles in a functional matter [7].
There is also strong evidence for PFM training as conservative treatment
for stress urinary incontinence [5,8]. Treatment should also include
education on healthy lifestyle habits to promote optimal functioning of
the lumbopelvic stability system. Examples of these habits include good
posture, maintenance of a healthy body weight, proper diet, routine
exercise, and refraining from smoking [6]. This purpose of this study
was to evaluate whether the implementation of lifestyle modifications as
well as a specialized exercise program would improve the symptoms of
pelvic floor dysfunction and mild pelvic organ prolapse in women. These
symptoms include low back pain, hip pain, pelvic pressure, pelvic pain
with intimacy and/or the use of tampons, bladder and/or bowel leakage
with laughing, coughing, sneezing, jumping, bladder and/or bowel urgency
and frequency. The research addressed whether the interventions
proposed lead to improvements in pain levels and quality of life. The
study evaluated the severity of the participants' symptoms pre and post
intervention (Table 1).
Design
Initially, a five-week pilot study that included 10 female subjects
aged 44.1 + 8.4 years (mean + s.d.) was implemented to determine if a
study of 60 female participants aged 35-65 years old was warranted and
if protocol modifications were necessary The project was approved by the
Institutional Review Board (IRB) from the University of New Orleans.
The pilot test sample was a convenience sample. The subjects were
selected because they exhibited symptoms of pelvic floor dysfunction as
defined by the following 3 assessment questionnaires, as follows:
- a) Pelvic Floor Distress Inventory Questionnaire - Short Form 30 (PFDI-SF20)
b) (assesses if the participant has certain bowel, bladder, or pelvic symptoms and how much they bother the participant.) [9]
i. Exclusion from study if answer 'yes' on question 3, 4, 6, or 14 (indicating symptoms are too advanced for safe participation)
ii. Exclusion from study if total score is greater than 200, out of possible score range of 0-300 (indicating symptoms are too advanced for safe participation)
c) Oswestry Low Back Pain Disability Questionnaire
d) (measures how participants' back or leg pain is affecting their ability to manage in everyday life.)[10]
i. Exclusion from study if total score is equal to or greater than 41%, indicating 'severe disability' to 'crippled'
e) Pelvic Floor Impact Questionnaire - short form 7 (PFIQ-7)
f) (measures how much bladder, bowel, or vaginal symptoms affect the participant s activities, relationships, and feelings.) [9]
g) Exclusion from study if 'quite a bit’ is answered in all 3 columns for questions 1 or 2 (indicating symptoms are too advanced for safe participation.
Subjects were excluded from the study if they are assessed to have
greater than a 3 finger-width diastasis recti abdominal separation as
measured by one of the co-investigators. The subjects were recruited
from the greater New Orleans metropolitan area using informational
fliers, Facebook video ads, email messages and community postings of the
same flier. All subjects signed a letter of informed consent stating
that the study was voluntary and confidential and that all results would
be kept in a locked environment. Participation was voluntary and
low-risk. Exclusion criteria ensured that those with advanced symptoms
were referred for medical consultation. All participants had ample
opportunity for questions to be answered as needed by the
co-investigator clinicians during the live sessions. The subjects were
not remunerated.
During the course of the 5-week pilot study one of the participants
was dropped from the study due to protocol noncompliance, so only 9
subjects completed the pilot study. The pilot study design included pre-
and post- research-validated quality of life assessments [11], In Body
570 body composition measurements [12], pelvic alignment assessments
[13], diastasis recti assessments, and manual external pelvic floor
muscle activation assessments [14]. Participants were instructed in
specific lifestyle modifications and were taught an exercise program
over the course of seven live group sessions, 45 minutes each, to be led
by one or both of the coinvestigator clinicians. Participants were also
instructed to perform a home exercise program at least 5 days per week
and complete compliance forms to be turned in at each live group
session. The two research clinicians were a licensed physical therapist
and a clinical exercise physiologist.
Analysis
IBM SPSS Version 24 statistical programming was utilized and
non-parametric, Wilcoxon "related-items" analyses were employed. A 0.05
level of significance was used.
Results
A comparison of the subjects’ results of the pre- and post- values
from the 5-week pilot test indicated significant improvements of lower
back pain (Oswestry, z(9) = -2.556, p < .05), significant
improvements of the quality of life (subjective emotional gauge, PFDI
-20, z(9) = -2.666, p < .05), and significant improvements of bladder
symptoms (PFIQ - 7, z(9) = -2.536, p < .05).
Discussion
Although the sample of the pilot test was not large enough to
eliminate statistical bias, the results warranted a continuation of the
study. The full study of 60 female volunteers proceeded as planned with
no modifications to the proposed study’s protocol. Researchers are
currently recruiting volunteers for the full study.
In the Guidelines for Physicians and Urologists
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