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Musculoskeletal and Obstetric Management Study (MOMS)

19. mai 2009 oppdatert av: Logan College of Chiropractic

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.

Studieoversikt

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

160

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Center for Advanced Medicine
      • St. Louis, Missouri, Forente stater, 63110
        • Barnes-Jewish Hospital
      • St. Louis, Missouri, Forente stater, 63131
        • Missouri Baptist Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

15 år til 45 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MOMS
Receives manual therapy, stabilization exercise and patient education
Receives manual therapy, stabilization exercise and patient education
Aktiv komparator: STOB
Receive standard obstetrical care
Receive standard obstetrical care

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Quebec Task Force Disability Scale Questionnaire (QDQ)
Tidsramme: Baseline, 33 weeks of gestation and 3 months postpartum
Baseline, 33 weeks of gestation and 3 months postpartum

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2006

Primær fullføring (Forventet)

1. juni 2009

Studiet fullført (Forventet)

1. juni 2009

Datoer for studieregistrering

Først innsendt

18. mai 2009

Først innsendt som oppfylte QC-kriteriene

19. mai 2009

Først lagt ut (Anslag)

20. mai 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. mai 2009

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. mai 2009

Sist bekreftet

1. mai 2009

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 06-0998
  • 417 (DRD)
  • 1 R18HP07640-01-00 (Award #)
  • R18HP07640 (Grant #)
  • RD1012060046 (Logan IRB #)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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