Intervention for Pregnancy Related Pain

Mulligan Concept Intervention for Pregnancy Related Lumbo Pelvic Pain

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.

Study Overview

• Status: Completed
• Conditions: Other Specified Pregnancy-Related Conditions
• Intervention / Treatment: Other: Mulligan Concept Intervention; Other: Sham Mulligan Concept Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Moscow, Idaho, United States, 83844
      • Integrated Sport Medicine and Rehabilitative Therapy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mulligan Concept Intervention; Mulligan Concept Intervention, including Mobilizations with Movement intervention is administered. Up to 30 minutes total treatment time.	Other: Mulligan Concept Intervention; The concept is a manual therapy paradigm that includes a clinician applying joint mobilizations and having the patient perform concurrent active, pain free, movement.
Sham Comparator: Sham Mulligan Concept Treatment; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-D motion Analysis- sit to stand	Kinematic data is collected during sit to stand task	Change from pre to post intervention (immediate, 30 minutes)
3-D Motion Analysis- gait	Kinematic data is collected during gait task	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	Change from pre to post intervention (immediate, 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography- Sit to Stand	EMG data will be collected during the sit to stand task	Change from pre and post intervention (Immediate, 30 minutes)
Electromyography- Gait	EMG data will be collected during gait task	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.	Change from pre and post intervention (Immediate, 30 minutes)
Visual Analog Pain Scale	Patient Reported Outcome Measure, pain	Change from pre and post intervention (Immediate, 30 minutes)
Pelvic Girdle Questionnaire	Patient Reported Outcome Measure, region specific disablement	Change from pre and post intervention (Immediate, 30 minutes)
Assessment of Disablement Questionnaire	Patient Reported Outcome Measure, global disablement	Change from pre and post intervention (Immediate, 30 minutes)
Short Stress State Questionnaire	Patient Reported Outcome Measure, stress	Change from pre and post intervention (Immediate, 30 minutes)

Collaborators and Investigators

• Sponsor: University of Idaho
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Lindsay Larkins, DAT, University of Idaho

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: pain; pregnancy; manual therapy; spine; pelvis
• Other Study ID Numbers: 17-042; 18-22QR-UI-PG76 (Other Grant/Funding Number: Clinical Translational Research Infrastructure Network)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No