Clinical trial NCT03440073: Intervention for Pregnancy Related Pain
Official title: Mulligan Concept Intervention for Pregnancy Related Lumbo Pelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Specified Pregnancy-Related Conditions
Keywords: pregnancy
pain
pelvis
spine
manual therapy
Lead sponsor: University of Idaho
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-02-20
Enrollment: 36
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* reported pregnancy-related lumbopelvic pain

Exclusion Criteria:

* orthopaedic or neurological problems with walking
* 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
* does not receive consent from their maternity care provider
* pain is associated with something other than pregnancy, or is experienced outside of pregnancy prior to the first pregnancy

Primary outcomes:
measure: 3-D motion Analysis- sit to stand
timeFrame: Change from pre to post intervention (immediate, 30 minutes)
measure: 3-D Motion Analysis- gait
timeFrame: Change from pre to post intervention (immediate, 30 minutes)
measure: 3-D Motion Analysis- active straight leg raise
timeFrame: Change from pre to post intervention (immediate, 30 minutes)
Secondary outcomes:
measure: Electromyography- Sit to Stand
timeFrame: Change from pre and post intervention (Immediate, 30 minutes)
measure: Electromyography- Gait
timeFrame: Change from pre and post intervention (Immediate, 30 minutes)
measure: Electromyography- Straight Leg Raise
timeFrame: Change from pre and post intervention (Immediate, 30 minutes)
measure: Visual Analog Pain Scale
timeFrame: Change from pre and post intervention (Immediate, 30 minutes)
measure: Pelvic Girdle Questionnaire
timeFrame: Change from pre and post intervention (Immediate, 30 minutes)
measure: Assessment of Disablement Questionnaire
timeFrame: Change from pre and post intervention (Immediate, 30 minutes)
measure: Short Stress State Questionnaire
timeFrame: Change from pre and post intervention (Immediate, 30 minutes)
Other outcomes:
Locations:
city: Moscow
country: United States
facility: Integrated Sport Medicine and Rehabilitative Therapy Clinic
state: Idaho
Study officials:
affiliation: University of Idaho
name: Lindsay Larkins, DAT
role: PRINCIPAL_INVESTIGATOR
References: