Intervention for Pregnancy Related Pain

October 22, 2018 updated by: University of Idaho

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3-D motion Analysis- sit to stand
Time Frame: Change from pre to post intervention (immediate, 30 minutes)
Kinematic data is collected during sit to stand task
Change from pre to post intervention (immediate, 30 minutes)
3-D Motion Analysis- gait
Time Frame: Change from pre to post intervention (immediate, 30 minutes)
Kinematic data is collected during gait task
Change from pre to post intervention (immediate, 30 minutes)
3-D Motion Analysis- active straight leg raise
Time Frame: Change from pre to post intervention (immediate, 30 minutes)
Kinematic data is collected during active straight leg raise task
Change from pre to post intervention (immediate, 30 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electromyography- Sit to Stand
Time Frame: Change from pre and post intervention (Immediate, 30 minutes)
EMG data will be collected during the sit to stand task
Change from pre and post intervention (Immediate, 30 minutes)
Electromyography- Gait
Time Frame: Change from pre and post intervention (Immediate, 30 minutes)
EMG data will be collected during gait task
Change from pre and post intervention (Immediate, 30 minutes)
Electromyography- Straight Leg Raise
Time Frame: Change from pre and post intervention (Immediate, 30 minutes)
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
Time Frame: Change from pre and post intervention (Immediate, 30 minutes)
Patient Reported Outcome Measure, pain
Change from pre and post intervention (Immediate, 30 minutes)
Pelvic Girdle Questionnaire
Time Frame: Change from pre and post intervention (Immediate, 30 minutes)
Patient Reported Outcome Measure, region specific disablement
Change from pre and post intervention (Immediate, 30 minutes)
Assessment of Disablement Questionnaire
Time Frame: Change from pre and post intervention (Immediate, 30 minutes)
Patient Reported Outcome Measure, global disablement
Change from pre and post intervention (Immediate, 30 minutes)
Short Stress State Questionnaire
Time Frame: Change from pre and post intervention (Immediate, 30 minutes)
Patient Reported Outcome Measure, stress
Change from pre and post intervention (Immediate, 30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Idaho

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lindsay Larkins, DAT, University of Idaho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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