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Musculoskeletal and Obstetric Management Study (MOMS)
Musculoskeletal and Obstetric Management Study (MOMS)
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Missouri
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St Louis, Missouri, Verenigde Staten, 63110
- Center for Advanced Medicine
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St. Louis, Missouri, Verenigde Staten, 63110
- Barnes-Jewish Hospital
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St. Louis, Missouri, Verenigde Staten, 63131
- Missouri Baptist Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: MOMS
Receives manual therapy, stabilization exercise and patient education
|
Receives manual therapy, stabilization exercise and patient education
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Actieve vergelijker: STOB
Receive standard obstetrical care
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Receive standard obstetrical care
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Quebec Task Force Disability Scale Questionnaire (QDQ)
Tijdsspanne: Baseline, 33 weeks of gestation and 3 months postpartum
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Baseline, 33 weeks of gestation and 3 months postpartum
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Numerical Rating Scale (NRS)
Tijdsspanne: Baseline, 33 weeks of gestation and 3 months postpartum
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Baseline, 33 weeks of gestation and 3 months postpartum
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Personal Pain History (PPH)
Tijdsspanne: Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
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Straight Leg Raise (SLR)
Tijdsspanne: Baseline, 33 weeks of gestation and 3 months postpartum
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Baseline, 33 weeks of gestation and 3 months postpartum
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Active Straight Leg Raise (ASLR)
Tijdsspanne: Baseline, 33 weeks of gestation and 3 months postpartum
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Baseline, 33 weeks of gestation and 3 months postpartum
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Long Dorsal Ligament Test (LDLT)
Tijdsspanne: Baseline, 33 weeks of gestation and 3 months postpartum
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Baseline, 33 weeks of gestation and 3 months postpartum
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Posterior Pelvic Pain in Pregnancy Test (P4)
Tijdsspanne: Baseline, 33 weeks of gestation and 3 months postpartum
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Baseline, 33 weeks of gestation and 3 months postpartum
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Extensor Endurance Test (EET)
Tijdsspanne: 3 months postpartum
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3 months postpartum
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Flexor Endurance Test (FET)
Tijdsspanne: 3 months postpartum
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3 months postpartum
|
Side Bridge (SB)
Tijdsspanne: 3 months postpartum
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3 months postpartum
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 06-0998
- 417 (DRD)
- 1 R18HP07640-01-00 (Award #)
- R18HP07640 (Grant #)
- RD1012060046 (Logan IRB #)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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