- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00905112
Musculoskeletal and Obstetric Management Study (MOMS)
Musculoskeletal and Obstetric Management Study (MOMS)
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Missouri
-
St Louis, Missouri, Stati Uniti, 63110
- Center for Advanced Medicine
-
St. Louis, Missouri, Stati Uniti, 63110
- Barnes-Jewish Hospital
-
St. Louis, Missouri, Stati Uniti, 63131
- Missouri Baptist Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: MOMS
Receives manual therapy, stabilization exercise and patient education
|
Receives manual therapy, stabilization exercise and patient education
|
Comparatore attivo: STOB
Receive standard obstetrical care
|
Receive standard obstetrical care
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Quebec Task Force Disability Scale Questionnaire (QDQ)
Lasso di tempo: Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Numerical Rating Scale (NRS)
Lasso di tempo: Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
Personal Pain History (PPH)
Lasso di tempo: Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
Straight Leg Raise (SLR)
Lasso di tempo: Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
Active Straight Leg Raise (ASLR)
Lasso di tempo: Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
Long Dorsal Ligament Test (LDLT)
Lasso di tempo: 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)
Lasso di tempo: Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
Extensor Endurance Test (EET)
Lasso di tempo: 3 months postpartum
|
3 months postpartum
|
Flexor Endurance Test (FET)
Lasso di tempo: 3 months postpartum
|
3 months postpartum
|
Side Bridge (SB)
Lasso di tempo: 3 months postpartum
|
3 months postpartum
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 06-0998
- 417 (DRD)
- 1 R18HP07640-01-00 (Award #)
- R18HP07640 (Grant #)
- RD1012060046 (Logan IRB #)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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