Intervention for Pregnancy Related Pain
Condition: Other Specified Pregnancy-Related Conditions
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Mulligan Concept Intervention; Sham Mulligan Concept Treatment
Intervention type(s): Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pregnancy; pain; pelvis; spine; manual therapy