MOMS: Musculoskeletal and Obstetric Management Study

Sponsor

Logan College of Chiropractic (Other)

Overall Status

Unknown status

CT.gov ID

NCT00905112

Collaborator

Health Resources and Services Administration (HRSA) (U.S. Fed), Washington University School of Medicine (Other)

160

Enrollment

Locations

Arms

Duration (Months)

53.3

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Back Pain Pelvic Pain Musculoskeletal Pain	Other: Manual Therapy Other: Standard OB Care	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Musculoskeletal and Obstetric Management Study (MOMS)

Study Start Date :

Oct 1, 2006

Anticipated Primary Completion Date :

Jun 1, 2009

Anticipated Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Quebec Task Force Disability Scale Questionnaire (QDQ) [Baseline, 33 weeks of gestation and 3 months postpartum]

Secondary Outcome Measures

Numerical Rating Scale (NRS) [Baseline, 33 weeks of gestation and 3 months postpartum]
Personal Pain History (PPH) [Baseline, 33 weeks of gestation and 3 months postpartum]
Straight Leg Raise (SLR) [Baseline, 33 weeks of gestation and 3 months postpartum]
Active Straight Leg Raise (ASLR) [Baseline, 33 weeks of gestation and 3 months postpartum]
Long Dorsal Ligament Test (LDLT) [Baseline, 33 weeks of gestation and 3 months postpartum]
Posterior Pelvic Pain in Pregnancy Test (P4) [Baseline, 33 weeks of gestation and 3 months postpartum]
Extensor Endurance Test (EET) [3 months postpartum]
Flexor Endurance Test (FET) [3 months postpartum]
Side Bridge (SB) [3 months postpartum]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Advanced Medicine	St Louis	Missouri	United States	63110
2	Barnes-Jewish Hospital	St. Louis	Missouri	United States	63110
3	Missouri Baptist Medical Center	St. Louis	Missouri	United States	63131