Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Musculoskeletal and Obstetric Management Study (MOMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Logan College of Chiropractic.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Washington University School of Medicine
Information provided by:
Logan College of Chiropractic
ClinicalTrials.gov Identifier:
NCT00905112
First received: May 18, 2009
Last updated: May 19, 2009
Last verified: May 2009
  Purpose

The investigators propose such a trial to compare a Musculoskeletal and Obstetric Management (MOM) program to standard obstetric care alone for lower back pain/pelvic pain (LBP/PP) during and after pregnancy.


Condition Intervention
Lower Back Pain
Pelvic Pain
Musculoskeletal Pain
Other: Manual Therapy
Other: Standard OB Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Musculoskeletal and Obstetric Management Study (MOMS)

Resource links provided by NLM:


Further study details as provided by Logan College of Chiropractic:

Primary Outcome Measures:
  • Quebec Task Force Disability Scale Questionnaire (QDQ) [ Time Frame: Baseline, 33 weeks of gestation and 3 months postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numerical Rating Scale (NRS) [ Time Frame: Baseline, 33 weeks of gestation and 3 months postpartum ] [ Designated as safety issue: No ]
  • Personal Pain History (PPH) [ Time Frame: Baseline, 33 weeks of gestation and 3 months postpartum ] [ Designated as safety issue: No ]
  • Straight Leg Raise (SLR) [ Time Frame: Baseline, 33 weeks of gestation and 3 months postpartum ] [ Designated as safety issue: No ]
  • Active Straight Leg Raise (ASLR) [ Time Frame: Baseline, 33 weeks of gestation and 3 months postpartum ] [ Designated as safety issue: No ]
  • Long Dorsal Ligament Test (LDLT) [ Time Frame: Baseline, 33 weeks of gestation and 3 months postpartum ] [ Designated as safety issue: No ]
  • Posterior Pelvic Pain in Pregnancy Test (P4) [ Time Frame: Baseline, 33 weeks of gestation and 3 months postpartum ] [ Designated as safety issue: No ]
  • Extensor Endurance Test (EET) [ Time Frame: 3 months postpartum ] [ Designated as safety issue: No ]
  • Flexor Endurance Test (FET) [ Time Frame: 3 months postpartum ] [ Designated as safety issue: No ]
  • Side Bridge (SB) [ Time Frame: 3 months postpartum ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: October 2006
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MOMS
Receives manual therapy, stabilization exercise and patient education
Other: Manual Therapy
Receives manual therapy, stabilization exercise and patient education
Active Comparator: STOB
Receive standard obstetrical care
Other: Standard OB Care
Receive standard obstetrical care

Detailed Description:

Initially patients will have a Baseline Musculoskeletal Exam (BME) at 24-28 weeks pregnancy at which point self reported tests/questionnaires will be administered as well as functional testing (see below "procedures for research") performed. At this point patients will be randomized into either Standard Obstetric Management or Musculoskeletal and Obstetric Care (MOMS) groups:

Standard Obstetric Management : All patients (both groups) will be seen for standard obstetric care typically once every month. Complicated cases may need to be seen more frequently. There is no standard obstetric care approach to LBP/PP in pregnancy, thus, patients in the standard obstetric care group will receive limited, although realistic interventions for LBP/PP. In addition, patients will attend one-on-one educational sessions on pre-natal care. The women in this group will have a minimum of 4 pre-natal care sessions. These visits will be timed to match the additional time and care given to the MOM group. The timed sessions will be compared with the MOMS group at monthly intervals to maintain treatment attention equality. Patients will have a complete medical assessment including history and physical examination administered by their obstetrical provider. As part of their intervention for LBP/PP, evaluation of lifestyle and work activities may be taken into consideration. Modification of lifestyle may be recommended including, rest and general aerobic exercise. Short-lived heat treatment (i.e. heating pad for no more than 10 minutes) is another possibility. Use of analgesia may be prescribed, including acetaminophen and NSAID preparations, or narcotics if deemed necessary by the provider. Narcotic use and centrally acting muscle relaxants are typically not encouraged, but at times maybe necessary to help control pain. For pain that is debilitating and worsening, consultation with orthopedic or neurological services may be considered.

Musculoskeletal and Obstetric Management (MOM): In addition to their standard obstetric visits, patients in this group will see the MOM team every one to two weeks depending on severity of symptoms. We have found through treating pregnancy-related pain that visits every one to two weeks is sufficient as the majority of the cases are mild to moderate presentations of non-inflammatory pain. A standard history will be taken and the patient will be assessed for musculoskeletal conditions to identify signs of serious illness, neurological deficit and/or orthopedic instability. If any of these conditions are evident, the patient will be immediately referred for specialist consultation. The patients in this MOM group will be treated with biobehavioral management, manual therapy and spinal stabilization exercise as described in detail below. The obstetric physician and chiropractic physician will have coordinated schedules at each clinic. For pain that is debilitating and worsening, consultation with orthopedic or neurological services will be considered.

Patients will be assessed at 33 weeks gestation and 3 months post-partum and research end-points collected. Please see next cell for detailed description of these functional and endurance tests as well as self reported test.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female Patients 15-45 years of age
  • Pregnant - 24-28 weeks gestation
  • LBP and/or PP

Exclusion Criteria:

  • History of fracture, neoplasm, previous surgery of lumbar spine, pelvis, hip or femur
  • Acute inflammatory or infectious disease
  • Chronic pain prior to pregnancy (pain persisting for > 8 weeks prior to pregnancy)
  • Mental health disorder requiring medication/treatment
  • Back pain from visceral diseases
  • Peripheral vascular disease and/or cardiac disease requiring medical treatment
  • Severe disabling health problems
  • Substance abuse
  • Ongoing treatment for back pain by other health care providers
  • Pending or current litigation
  • Multiple birth pregnancies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905112

Locations
United States, Missouri
Center for Advanced Medicine
St Louis, Missouri, United States, 63110
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
Missouri Baptist Medical Center
St. Louis, Missouri, United States, 63131
Sponsors and Collaborators
Logan College of Chiropractic
Health Resources and Services Administration (HRSA)
Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Dr. Clayton Skaggs, Logan University, College of Chiropractic
ClinicalTrials.gov Identifier: NCT00905112     History of Changes
Other Study ID Numbers: 06-0998, 417 (DRD), 1 R18HP07640-01-00 (Award #), R18HP07640 (Grant #), RD1012060046 (Logan IRB #)
Study First Received: May 18, 2009
Last Updated: May 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Logan College of Chiropractic:
Pregnancy
Pain
Musculoskeletal manipulations
Exercise

Additional relevant MeSH terms:
Low Back Pain
Musculoskeletal Pain
Pelvic Pain
Back Pain
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014