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Musculoskeletal and Obstetric Management Study (MOMS)

Primary Purpose

Lower Back Pain, Pelvic Pain, Musculoskeletal Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Therapy
Standard OB Care
Sponsored by
Logan College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring Pregnancy, Pain, Musculoskeletal manipulations, Exercise

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Advanced Medicine
  • Barnes-Jewish Hospital
  • Missouri Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MOMS

STOB

Arm Description

Receives manual therapy, stabilization exercise and patient education

Receive standard obstetrical care

Outcomes

Primary Outcome Measures

Quebec Task Force Disability Scale Questionnaire (QDQ)

Secondary Outcome Measures

Numerical Rating Scale (NRS)
Personal Pain History (PPH)
Straight Leg Raise (SLR)
Active Straight Leg Raise (ASLR)
Long Dorsal Ligament Test (LDLT)
Posterior Pelvic Pain in Pregnancy Test (P4)
Extensor Endurance Test (EET)
Flexor Endurance Test (FET)
Side Bridge (SB)

Full Information

First Posted
May 18, 2009
Last Updated
May 19, 2009
Sponsor
Logan College of Chiropractic
Collaborators
Health Resources and Services Administration (HRSA), Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00905112
Brief Title
Musculoskeletal and Obstetric Management Study
Acronym
MOMS
Official Title
Musculoskeletal and Obstetric Management Study (MOMS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Logan College of Chiropractic
Collaborators
Health Resources and Services Administration (HRSA), Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain, Pelvic Pain, Musculoskeletal Pain
Keywords
Pregnancy, Pain, Musculoskeletal manipulations, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MOMS
Arm Type
Experimental
Arm Description
Receives manual therapy, stabilization exercise and patient education
Arm Title
STOB
Arm Type
Active Comparator
Arm Description
Receive standard obstetrical care
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Receives manual therapy, stabilization exercise and patient education
Intervention Type
Other
Intervention Name(s)
Standard OB Care
Intervention Description
Receive standard obstetrical care
Primary Outcome Measure Information:
Title
Quebec Task Force Disability Scale Questionnaire (QDQ)
Time Frame
Baseline, 33 weeks of gestation and 3 months postpartum
Secondary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Time Frame
Baseline, 33 weeks of gestation and 3 months postpartum
Title
Personal Pain History (PPH)
Time Frame
Baseline, 33 weeks of gestation and 3 months postpartum
Title
Straight Leg Raise (SLR)
Time Frame
Baseline, 33 weeks of gestation and 3 months postpartum
Title
Active Straight Leg Raise (ASLR)
Time Frame
Baseline, 33 weeks of gestation and 3 months postpartum
Title
Long Dorsal Ligament Test (LDLT)
Time Frame
Baseline, 33 weeks of gestation and 3 months postpartum
Title
Posterior Pelvic Pain in Pregnancy Test (P4)
Time Frame
Baseline, 33 weeks of gestation and 3 months postpartum
Title
Extensor Endurance Test (EET)
Time Frame
3 months postpartum
Title
Flexor Endurance Test (FET)
Time Frame
3 months postpartum
Title
Side Bridge (SB)
Time Frame
3 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Center for Advanced Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Barnes-Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Missouri Baptist Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States

12. IPD Sharing Statement

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Musculoskeletal and Obstetric Management Study

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