An interventional study of Mulligan Concept Intervention and Sham Mulligan Concept Treatment in Other Specified Pregnancy-Related Conditions, sponsored by University of Idaho. Completed at 1 site in United States. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by University of Idaho · Not applicable, Interventional, and Treatment
Women in rural communities receive less access to prenatal care, and experience slightly higher rates of complications during pregnancy. A very prevalent pregnancy related complication is Pregnancy Related Pelvic Girdle Pain (PPGP), effecting up to 76% of all pregnant women. Historically, PPGP has been thought to originate from hormonal changes associated with pregnancy, but its cause is more likely due to loss of motor control and/or malpositioning of the pelvic bones. Despite growing interest and clinical awareness of the condition, treatment outcomes of PPGP are inconsistent and intervention studies are lacking. The goal of this proposal is to investigate a treatment modality with minimal risks and potential to be self-administered. The Mulligan Concept manual therapy technique aims to restore mechanical function of the lumbopelvic region and has yet to be measured in women with PPGP.
The long-term goal of this project is to develop an effective conservative treatment protocol that is easily accessible. The objective of this application is to determine if patients who are treated with Mulligan Concept manual therapy experience immediate and significant changes in pain and function. Our specific aims are: In women with PPGP, 1.) Determine if Mulligan Concept treatment produces immediate changes in pain and function, 2.) Determine whether the Mulligan Concept immediately restores or alters dysfunctional gait characteristics and pelvic girdle motor control, and 3.) Identify factors that mathematically predict treatment outcome. Our central hypothesis is that restoration of lumbopelvic positioning will result in immediate decrease in pain, increase in function, and improved gait mechanics.
Volunteers in the 20th-34th week of pregnancy, ages 20-45 years, who are experiencing PPGP will be screened and randomly assigned into treatment or placebo group based on age, weight, height, gestational week and number of pregnancies. All participants will undergo a standardized examination, complete patient reported outcome measures, and perform a walking gait, sit to stand, and active straight leg raise tasks. Kinematic, kinetic, and EMG recordings will be taken during performance of the tasks. The participants of the treatment group will receive a Mulligan Concept evaluation and treatment. Participants in the placebo group will receive only the Mulligan Concept evaluation. Participants will then repeat the same tasks and measures. The study will be conducted under a randomized triple blinded placebo trial design; the patients, researchers, and treating clinician will be blinded to group assignment. Independent sample t-tests will be conducted to determine if significant differences exist between the intervention and placebo group across several dependent variables. Regression analysis will be conducted in order to determine if intake factors mathematically predict treatment outcome.
Exclusion Criteria:
Mulligan Concept Intervention, including Mobilizations with Movement intervention is administered. Up to 30 minutes total treatment time.
Other: Mulligan Concept Intervention
Assessment procedures of the Mulligan Concept are followed, but no manual pressure is applied to the participant during treatment to provide a sham Mulligan Concept Treatment.
Other: Sham Mulligan Concept Treatment
The concept is a manual therapy paradigm that includes a clinician applying joint mobilizations and having the patient perform concurrent active, pain free, movement.
The treating clinician will ask the participant to perform the movements associated with the Mulligan Concept technique. The clinician will have her hands on the participant during the movement but will not apply any pressure or force.
3-D motion Analysis- sit to stand
Kinematic data is collected during sit to stand task
Time frame: Change from pre to post intervention (immediate, 30 minutes)
3-D Motion Analysis- gait
Kinematic data is collected during gait task
Time frame: Change from pre to post intervention (immediate, 30 minutes)
3-D Motion Analysis- active straight leg raise
Kinematic data is collected during active straight leg raise task
Time frame: Change from pre to post intervention (immediate, 30 minutes)
Electromyography- Sit to Stand
EMG data will be collected during the sit to stand task
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Electromyography- Gait
EMG data will be collected during gait task
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Electromyography- Straight Leg Raise
EMG data will be collected during the sit to stand, gait, and active single leg raise tasks.
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Visual Analog Pain Scale
Patient Reported Outcome Measure, pain
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Pelvic Girdle Questionnaire
Patient Reported Outcome Measure, region specific disablement
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Assessment of Disablement Questionnaire
Patient Reported Outcome Measure, global disablement
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Short Stress State Questionnaire
Patient Reported Outcome Measure, stress
Time frame: Change from pre and post intervention (Immediate, 30 minutes)
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data will only be known to the PI. Other researchers working on the project are blinded to IPD. The PI will maintain records on a secure computer, with secure server connection, located in a locked office. Data will be shared in aggregate without identifying information.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Idaho