Mulligan Concept Intervention for Pregnancy Related Lumbo Pelvic Pain
Phase: NA
Conditions: Other Specified Pregnancy-Related Conditions
Sponsor: University of Idaho

Mulligan Concept Intervention for Pregnancy Related Lumbo-
Pelvic Pain 
NCT number: TBD 
 
Research Strategy 
February 7, 2018 

Research Strategy 
Significance  
Pregnancy-related pelvic girdle pain (PPGP), whether of the pelvic girdle or the 
lubopelvic junction, is exceptionally prevalent; reportedly, 45-76% of all pregnant women 
and 25% of postpartum women suffer from PPGP.3-8 A major cause of sick leave during 
pregnancy,17 PPGP greatly affects activities of daily living and is associated with risk of 
long-term back pain.7, 9-10 Women suffering from PPGP typically seek treatment from 
their primary care physician or obstetrician. Primary care physicians have historically 
been more responsible for providing pregnancy related care in the Pacific and Inland 
Northwest regions compared to national averages; however, a marked decline in the 
provision of pregnancy related care has occurred in Alaska, Idaho, Montana, and 
Wyoming since 1999.1, 11  
Maternal health disparities exist in rural communities and are accompanied by 
poor health outcomes and increased healthcare costs.11 Consequently, a call has been 
made for solutions stemming from problems related to diminishing access to care.1,3 
Limited access means that positive and impactful patient outcomes at each visit are 
even more critical. Giving health care professionals more effective intervention options 
can help make limited visits more efficient, increase patient outcomes, decrease 
maternal health disparity in rural communities, as well as help women across the nation. 
Researchers and clinicians have theorized PPGP to be caused by a widening of 
the pelvis in response to hormonal changes during pregnancy, creating instability in the 
sacroiliac (SI) joints.3, 12 While the theory is logical, evidence does not support hormone 
induced ligament laxity having a role in the etiology of PPGP.6 A more likely cause is 
mechanical dysfunction, such as malposition of bones in the lumbopelvic region, which 
has been observed in radiographic and gait analysis studies.3, 5, 12, 15 Mechanical 
changes are correlated with failure of the load transfer mechanism of the SI joints, 
movement dysfunction, and pain.14 Clinical intervention for PPGP ranges from 
acupuncture to stabilization exercises to corticosteroid injections, with only mildly 
positive results because these treatments are not aimed at correcting underlying 
mechanical and motor control dysfunction.10  
The Mulligan Concept is a manual therapy paradigm used to correct pain of 
mechanical origin by using specific joint mobilizations with limb movement to restore 
functional relationships between joint surfaces. The purported benefits of the Mulligan 
Concept are an immediate reduction or abolition of pain, immediate restoration of 
function, and options for self-treatment.15, 14, 16 The effects of a manual therapy 
intervention aimed at restoring mechanical and motor control function of the lumbopelvic 
region have yet to be measured in women with PPGP. The proposed project will improve 
knowledge surrounding PPGP and create evidence for clinical practice options. If the 
proposed aims are achieved, we will have a better understanding of the efficacy of the 
Mulligan Concept for use in the pregnant population, build upon current research 
associating poor motor control to PPGP, and introduce novel assessment and treatment 
procedures for women suffering from PPGP. 
 
Innovation 
There is growing consensus that the etiology of PPGP is not due to hormonally 
induced laxity, but a combination of mechanical and motor control dysfunctions.3, 5, 8, 12 
Researchers have identified gait characteristics and joint relationships differences that 
are unique to patients with PPGP; not found in pregnant women with out PPGP or in 
patients with simple low back pain.3, 8, 10 Positional abnormalities (e.g., subluxation of the 
pubic symphysis), changes in gait (e.g., thoracic and lumbar rotation timing and 
amplitude), and muscle activation patterns have been associated with the syndrome but 

not found in matched healthy subjects.3, 8,13  Failure of the load transfer mechanism of 
the sacroiliac joints, specifically, is associated with positional displacements of the joints 
in pelvic girdle and can cause dysfunctional pelvic girdle movement, loss of motor 
control, pain and disability.18-20 Researchers have yet to conduct intervention trials to 
determine whether these associated dysfunctions can be altered with treatment. A 
clinician utilizing the Mulligan Concept would aim to simultaneously restore the load 
transfer mechanism and correct the malpositioning of the joints of the pelvis through 
mobilizations and patient movement. The concept is novel and has yet to be tested in 
this population. This application seeks to shift current research toward clinical 
intervention trials that close the evidence-based medicine gap and aim to inform clinical 
practice. 
 
Approach 
Twenty pregnant volunteers, ages 20-45 years, will be recruited for the study. 
Participants will be between their 20th-34th week of gestation, with reported pregnancy-
related lumbopelvic pain. Participants would be excluded for any of the following criteria: 
• 
orthopaedic or neurological problems with walking (other than PPGP) 
• 
prior surgery of the lumbar spine, pelvis, hip, or knee 
• 
fracture 
• 
known malignancy 
• 
active inflammation in the lumbar spine or pelvis 
• 
ankylosing spondylitis, Scheuermann’s kyphosis, active polyarthritis, or severe 
osteoporosis 
• 
any pulmonary, cardiac, visual, auditory, or cognitive disorders 
• 
any other multi/co-morbidities that limit the volunteers ability to complete a gait 
and sit-to-stand task 
Volunteers will be recruited from Latah County, Idaho and surrounding areas by 
word of mouth and print and social media. Pregnant women who express interest in the 
study will be given an informational packet explaining the methods, risks, and benefits of 
participation. If the women decide to participate they would sign a consent statement 
and conduct an initial questionnaire, sent via online link. The survey would be used to 
determine inclusion and exclusion criteria, and group assignment (i.e., intervention 
group, placebo group). Un-paired t-tests will be conducted to determine whether 
significant differences exist between intervention and control groups in age, weight, 
height, as well as gestational week and number of pregnancies. Randomly stratifying the 
participants in to groups in this manner minimizes the potential confounding variables.  
Participants will report to the University of Idaho Integrated Sport Medicine and 
Rehabilitative Therapy Clinic for initial patient reported outcome measures collection and 
standardized examination. Primary patient reported outcome measures include the 
Visual Analog Pain Scale, the Pelvic Girdle Questionnaire, the Assessment of 
Disablement Questionnaire, the Patient Specific Function Scale, and the Short Stress 
State Questionnaire. The examination will include history, palpation, special tests (e.g., 
Posterior Pelvic Pain Provocation test, Active Straight Leg Raise), and neurological 
screen.  
Each participant will then perform a walking gait and sit-to-stand task as a 
baseline, in the University of Idaho Biomechanics Laboratory. An eight-infrared camera 
optical system (Vicon Motion Systems Ltd., Oxford, UK) and forceplate (AMTI, 
Watertown, MA, USA) will be used to collect the kinematic and kinetics data during the 
tasks. In addition, an eight-channel wireless electromyography (EMG) system (Delays, 
Inc., Natick, MA, USA) will be used to collect muscle activity during the gait and sit-to-

stand tasks, and the active straight leg raise (ASLR) special test. The participants in the 
treatment group will receive a Mulligan Concept evaluation and treatment administered 
by a Certified Mulligan Practitioner. The placebo group will undergo only the Mulligan 
Concept evaluation. The same tasks and ASLR will be repeated. Outcome measures 
and physical examination will also be repeated. 
The study will be conducted under a randomized triple blinded placebo trial 
design. Neither the participants, the treating clinician, biomechanist, nor researcher 
collecting outcome measures will know the group designation of the participants. 
Conducting the trial in this manner will ensure the lowest possibility that any observed 
effects of the intervention are due to confounding factors. 
 
Statistical Analysis 
Sample size calculations were conducted to determine the appropriate number of 
participants that must be included. A sample size of 17 participants per group is needed 
to detect differences between groups with 80% power, and an a priori alpha of 0.05.  
Accounting for a reasonable 5% drop out rate, the final recommended number of 
participants is 36 (18 participants per group). 
Specific Aim #1: Determine if Mulligan Concept manual therapy produces immediate 
changes in pain and self-reported function in women with PPGP.  
A series of independent samples t-tests will be used to determine if a difference 
exists between the mean scores of the intervention and placebo groups on the VAS, 
PSFS, ADQ, and PGQ. 
Specific Aim #2: Determine whether treatment with the Mulligan Concept immediately 
restores or alters dysfunctional gait characteristics and pelvic girdle motor control in 
women experiencing PPGP. 
The timing and amplitude of lumbar and thoracic spine rotations, as well as 
muscle activity, will be recorded and compared using descriptive statistics. Between 
groups analysis will consist of descriptive statistics to compare differences in timing, 
amplitude, and EMG activity after intervention. 
Specific Aim #3: Identify intake factors that predict treatment outcome.  
Standard multiple regression and step-wise multiple regression will be used to 
predict treatment outcome from different factors of interest (e.g., number of pregnancies, 
week of gestation, initial ADQ score, etc.). 
 
Project Timeline 
Preparation for participant recruitment will begin July 15th, 2017. Participant 
recruitment will take place between December 2017 and March 2018. Data collection will 
take place over 5-6 days in late March 2018. Data Analysis will take place between April 
and May 2018. Abstract and manuscript development and preparation for publication 
and presentation will take place through December 2018. 
 
Interim Milestones 
 
The following interim milestones will be used to hold the PI and research team 
accountable. These milestones will be shared with the research team and overseen by 
the PI. When appropriate and if a milestone is not met in a timely fashion, guidance will 
be sought from the Mentor and a plan for re-establishing the project timeline will be 
established and implemented. 
 
 
 
 

Phase 
Milestone 
Timeline 
Study Start Up 
• IRB Approval 
 
• Award Announcement 
• Preparation 
 
• Pre-recruitment planning 
(e.g., creation of media 
material) 
• Prior to March 1, 2017 
 
• May 31, 2017 
• July 15- October 1, 
2017 
• October 1- December 
1, 2017 
Study Conduct 
• Ready to Recruit  
• Materials completely 
distributed 
• 50% Enrollment Achieved 
• 100% Enrollment 
Achieved 
• Data Collection 
• December 1, 2017 
• January 15, 2018 
 
• February 20, 2018 
 
• March 15, 2018 
 
• Late March, 2018 
Study Close-out 
• Attendance at Annual 
Meeting 
• Publication within 12 
months of study close 
• May, 2018 
• December, 2018 
 
Plans for developing and submitting future grant applications 
This grant application marks continued steps toward becoming an independent 
and successful researcher. The project will enable the PI to further establish her work in 
patient-care and manual therapy research, where she has had previous experience in 
relation to core motor control. Additionally, this project will aid in the PI’s professional 
development by establishing University and community collaborations. 
Information gathered from this exploratory trial will greatly inform next steps in a 
long line of research and allows the PI to collect preliminary data and develop evidence 
for interventions in an underserved population. For example, if the central hypothesis is 
confirmed, further investigation into the Mulligan Concept as treatment for PPGP in this 
population is warranted. A larger-scale multi-site randomized control trial with large 
sample size and more diverse sample would be the next logical step to create more 
robust evidence of the technique. Once the efficacy of the treatment protocol is 
established, exploration of a patient-applied treatment as a home program would be 
developed. If the kinematic, kinetic, pain and dysfunction effects can be well established, 
continued research would not necessarily focus on the biomechanical mechanisms, but 
would be more clinical in nature; a full scale clinical trial, focusing on treatment outcome, 
comorbidity, predictive factors of treatment outcome, risks, and side effects, etc. Future 
research will not be equipment heavy, but need funding primarily for participant 
recruitment, clinician training, and researcher salaries. Exploratory/Developmental 
research grants such as the NIH R21, or multi-site collaborative grants such as the CTR-
IN Multi-Site Research Project Program, would be an ideal funding mechanisms for the 
next stages of this research line.