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.
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
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.
- Conditions
- Lower Back Pain, Pelvic Pain, Musculoskeletal Pain
- 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 group | Role | What they receive |
|---|---|---|
| MOMS | Experimental | Receives manual therapy, stabilization exercise and patient education Receives: Other: Manual Therapy |
| STOB | Active comparator | Receive 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.
Quebec Task Force Disability Scale Questionnaire (QDQ)
Measured: Baseline, 33 weeks of gestation and 3 months postpartum
Secondary outcomes (9)
Numerical Rating Scale (NRS)
Measured: Baseline, 33 weeks of gestation and 3 months postpartum
Personal Pain History (PPH)
Measured: Baseline, 33 weeks of gestation and 3 months postpartum
Straight Leg Raise (SLR)
Measured: Baseline, 33 weeks of gestation and 3 months postpartum
Active Straight Leg Raise (ASLR)
Measured: Baseline, 33 weeks of gestation and 3 months postpartum
Long Dorsal Ligament Test (LDLT)
Measured: Baseline, 33 weeks of gestation and 3 months postpartum
Posterior Pelvic Pain in Pregnancy Test (P4)
Measured: Baseline, 33 weeks of gestation and 3 months postpartum
Extensor Endurance Test (EET)
Measured: 3 months postpartum
Flexor Endurance Test (FET)
Measured: 3 months postpartum
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.
- First posted20 May 2009 (estimated)
- Study startOct 2006
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Washington University School of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal and Obstetric Management Study (MOMS)
- ClinicalTrials.gov ID
- NCT00905112
- Acronym / sponsor ID
- MOMS / 06-0998
- Conditions
- Lower Back Pain, Pelvic Pain, Musculoskeletal Pain
- Keywords
- Pregnancy, Pain, Musculoskeletal manipulations, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), Washington University School of Medicine
- Study start
- Oct 2006
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 20 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOMS | Experimental | Other: Manual TherapyReceives manual therapy, stabilization exercise and patient education |
| STOB | Active comparator | Other: Standard OB CareReceive standard obstetrical care |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Female Patients 15-45 years of age
- Pregnant - 24-28 weeks gestation
- LBP and/or PP
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual TherapyReceives manual therapy, stabilization exercise and patient education | Other | MOMS |
| Standard OB CareReceive standard obstetrical care | Other | STOB |
Primary outcome
Quebec Task Force Disability Scale Questionnaire (QDQ)
Time frame: Baseline, 33 weeks of gestation and 3 months postpartum
9 secondary outcomes
Numerical Rating Scale (NRS)
Time frame: Baseline, 33 weeks of gestation and 3 months postpartum
Personal Pain History (PPH)
Time frame: Baseline, 33 weeks of gestation and 3 months postpartum
Straight Leg Raise (SLR)
Time frame: Baseline, 33 weeks of gestation and 3 months postpartum
Active Straight Leg Raise (ASLR)
Time frame: Baseline, 33 weeks of gestation and 3 months postpartum
Long Dorsal Ligament Test (LDLT)
Time frame: Baseline, 33 weeks of gestation and 3 months postpartum
Posterior Pelvic Pain in Pregnancy Test (P4)
Time frame: Baseline, 33 weeks of gestation and 3 months postpartum
Extensor Endurance Test (EET)
Time frame: 3 months postpartum
Flexor Endurance Test (FET)
Time frame: 3 months postpartum
Side Bridge (SB)
Time frame: 3 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
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.