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Intervention for Pregnancy Related Pain

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ClinicalTrials.gov Identifier: NCT03440073
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Idaho

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.

Condition or disease Intervention/treatment Phase
Other Specified Pregnancy-Related Conditions Other: Mulligan Concept Intervention Other: Sham Mulligan Concept Treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mulligan Concept Intervention for Pregnancy Related Lumbo Pelvic Pain
Actual Study Start Date : January 10, 2018
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

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.




Primary Outcome Measures :
  1. 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

  2. 3-D Motion Analysis- gait [ Time Frame: Change from pre to post intervention (immediate, 30 minutes) ]
    Kinematic data is collected during gait task

  3. 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


Secondary Outcome Measures :
  1. 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

  2. Electromyography- Gait [ Time Frame: Change from pre and post intervention (Immediate, 30 minutes) ]
    EMG data will be collected during gait task

  3. 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.

  4. Visual Analog Pain Scale [ Time Frame: Change from pre and post intervention (Immediate, 30 minutes) ]
    Patient Reported Outcome Measure, pain

  5. Pelvic Girdle Questionnaire [ Time Frame: Change from pre and post intervention (Immediate, 30 minutes) ]
    Patient Reported Outcome Measure, region specific disablement

  6. Assessment of Disablement Questionnaire [ Time Frame: Change from pre and post intervention (Immediate, 30 minutes) ]
    Patient Reported Outcome Measure, global disablement

  7. Short Stress State Questionnaire [ Time Frame: Change from pre and post intervention (Immediate, 30 minutes) ]
    Patient Reported Outcome Measure, stress



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440073


Locations
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United States, Idaho
Integrated Sport Medicine and Rehabilitative Therapy Clinic
Moscow, Idaho, United States, 83844
Sponsors and Collaborators
University of Idaho
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Lindsay Larkins, DAT University of Idaho
  Study Documents (Full-Text)

Documents provided by University of Idaho:
Informed Consent Form  [PDF] February 1, 2018


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Responsible Party: University of Idaho
ClinicalTrials.gov Identifier: NCT03440073     History of Changes
Other Study ID Numbers: 17-042
18-22QR-UI-PG76 ( Other Grant/Funding Number: Clinical Translational Research Infrastructure Network )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Idaho:
pregnancy
pain
pelvis
spine
manual therapy