Musculoskeletal Pain Clinical Trial
Official title:
Musculoskeletal and Obstetric Management Study (MOMS)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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