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Lower Back PainMOMSNCT00905112

Musculoskeletal and Obstetric Management Study

A study testing Manual Therapy and Standard OB Care in people with Lower Back Pain and Pelvic Pain, run by Logan College of Chiropractic at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 15 to 45 years, women only
Conditions the study is for
Lower Back Pain, Pelvic Pain, Musculoskeletal Pain
What is being tested?
Manual Therapy and Standard OB Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
3 sitesUnited States
Study dates
Oct 2006to Jun 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 45 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Female Patients 15-45 years of age
  • Pregnant - 24-28 weeks gestation
  • LBP and/or PP

Who cannot join

  • 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
Show all 11Show fewer
  • Severe disabling health problems
  • Substance abuse
  • Ongoing treatment for back pain by other health care providers
  • Pending or current litigation
  • Multiple birth pregnancies

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Center for Advanced Medicine

    St Louis, Missouri, 63110

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Manual Therapy, Standard OB Care
Keywords
Pregnancy, Pain, Musculoskeletal manipulations, Exercise
Medical subject headings
Low Back Pain, Pelvic Pain, Musculoskeletal Pain, Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual TherapyOther

    Receives manual therapy, stabilization exercise and patient education

  • Standard OB CareOther

    Receive standard obstetrical care

Study groups in NCT00905112
Study groupRoleWhat they receive
MOMSExperimentalReceives manual therapy, stabilization exercise and patient education
Receives: Other: Manual Therapy
STOBActive comparatorReceive standard obstetrical care
Receives: Other: Standard OB Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quebec Task Force Disability Scale Questionnaire (QDQ)

    Measured: Baseline, 33 weeks of gestation and 3 months postpartum

Secondary outcomes (9)
  1. Numerical Rating Scale (NRS)

    Measured: Baseline, 33 weeks of gestation and 3 months postpartum

  2. Personal Pain History (PPH)

    Measured: Baseline, 33 weeks of gestation and 3 months postpartum

  3. Straight Leg Raise (SLR)

    Measured: Baseline, 33 weeks of gestation and 3 months postpartum

  4. Active Straight Leg Raise (ASLR)

    Measured: Baseline, 33 weeks of gestation and 3 months postpartum

  5. Long Dorsal Ligament Test (LDLT)

    Measured: Baseline, 33 weeks of gestation and 3 months postpartum

  6. Posterior Pelvic Pain in Pregnancy Test (P4)

    Measured: Baseline, 33 weeks of gestation and 3 months postpartum

  7. Extensor Endurance Test (EET)

    Measured: 3 months postpartum

  8. Flexor Endurance Test (FET)

    Measured: 3 months postpartum

  9. Side Bridge (SB)

    Measured: 3 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2009 (estimated)
  2. Study startOct 2006
  3. Primary completionJun 2009 (estimated)
  4. Study completionJun 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00905112
Sponsor's protocol ID
06-0998
Other IDs
417 (DRD), 1 R18HP07640-01-00 (Award #), R18HP07640 (Grant #), RD1012060046 (Logan IRB #)
Acronym
MOMS
Status last verified
May 2009
First submitted
18 May 2009
Last updated
20 May 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Manual Therapy and Standard OB Care in people with Lower Back Pain and Pelvic Pain, run by Logan College of Chiropractic at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quebec Task Force Disability Scale Questionnaire (QDQ) (time frame: Baseline, 33 weeks of gestation and 3 months postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2009.

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