Musculoskeletal and Obstetric Management Study (MOMS)
Musculoskeletal and Obstetric Management Study (MOMS)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Missouri
-
St Louis、Missouri、アメリカ、63110
- Center for Advanced Medicine
-
St. Louis、Missouri、アメリカ、63110
- Barnes-Jewish Hospital
-
St. Louis、Missouri、アメリカ、63131
- Missouri Baptist Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:MOMS
Receives manual therapy, stabilization exercise and patient education
|
Receives manual therapy, stabilization exercise and patient education
|
|
アクティブコンパレータ:STOB
Receive standard obstetrical care
|
Receive standard obstetrical care
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Quebec Task Force Disability Scale Questionnaire (QDQ)
時間枠:Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Numerical Rating Scale (NRS)
時間枠:Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
|
Personal Pain History (PPH)
時間枠:Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
|
Straight Leg Raise (SLR)
時間枠:Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
|
Active Straight Leg Raise (ASLR)
時間枠:Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
|
Long Dorsal Ligament Test (LDLT)
時間枠: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)
時間枠:Baseline, 33 weeks of gestation and 3 months postpartum
|
Baseline, 33 weeks of gestation and 3 months postpartum
|
|
Extensor Endurance Test (EET)
時間枠:3 months postpartum
|
3 months postpartum
|
|
Flexor Endurance Test (FET)
時間枠:3 months postpartum
|
3 months postpartum
|
|
Side Bridge (SB)
時間枠:3 months postpartum
|
3 months postpartum
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。