Musculoskeletal and Obstetric Management Study

NCT ID: NCT00905112

Last Updated: 2009-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-06-30

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.

Conditions

Lower Back Pain; Pelvic Pain; Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MOMS

Receives manual therapy, stabilization exercise and patient education

Group Type: EXPERIMENTAL

Manual Therapy

Intervention Type: OTHER

Receives manual therapy, stabilization exercise and patient education

STOB

Receive standard obstetrical care

Group Type: ACTIVE_COMPARATOR

Standard OB Care

Intervention Type: OTHER

Receive standard obstetrical care

Interventions

Manual Therapy

Receives manual therapy, stabilization exercise and patient education

Intervention Type: OTHER

Standard OB Care

Receive standard obstetrical care

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Logan College of Chiropractic

OTHER

Sponsor Role: lead

Responsible Party

Logan University, College of Chiropractic

Locations

Barnes-Jewish Hospital

St Louis, Missouri, United States

Center for Advanced Medicine

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Countries

United States

Other Identifiers

417 (DRD)

Identifier Type: -

Identifier Source: secondary_id

1 R18HP07640-01-00 (Award #)

Identifier Type: -

Identifier Source: secondary_id

R18HP07640 (Grant #)

Identifier Type: -

Identifier Source: secondary_id

RD1012060046 (Logan IRB #)

Identifier Type: -

Identifier Source: secondary_id

06-0998

Identifier Type: -

Identifier Source: org_study_id