Low Back PainPhase 2NCT00298935
Study of the Effectiveness of Osteopathic Manipulative Treatment in Pregnant Women
A Phase 2 study testing Osteopathic manipulative treatment (OMT) in people with Low Back Pain and Musculoskeletal Diseases, run by University of North Texas Health Science Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether osteopathic manipulative treatment (OMT): decreases pain and improves physical functioning in women during the third trimester of pregnancy decreases complications during obstetrical delivery improves quality of life in the post-partum period Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Low Back Pain, Musculoskeletal Diseases, Pregnancy Complications
- What is being tested?
- Osteopathic manipulative treatment (OMT)
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jun 2006
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Third trimester pregnancy
Who cannot join
- High risk pregnancy
- Previous use of chiropractic manipulation, osteopathic manipulative treatment (OMT), physical therapy, or therapeutic ultrasound during the current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Osteopathic Research Center
Fort Worth, Texas, 76107
About this study
Official title: Pilot Clinical Trial of Osteopathic Manipulative Treatment (OMT) in Pregnancy
The purpose of this study is to determine whether osteopathic manipulative treatment (OMT):
- decreases pain and improves physical functioning in women during the third trimester of pregnancy
- decreases complications during obstetrical delivery
- improves quality of life in the post-partum period
Read the detailed description
Women experience multiple changes in their anatomy and physiology during pregnancy that may cause pain and adversely affect quality of life. Additionally, about ten percent of women will experience signs and symptoms of pre-eclampsia or pre-term labor during their first pregnancy.
Preliminary studies of osteopathic manipulative treatment (OMT) have demonstrated a decrease in pain during pregnancy, although the mechanisms responsible for this effect are unclear.
Another theory is that osteopathic manipulative treatment (OMT) may help normalize sympathetic outflow, thereby minimizing pregnancy complications. A recently published retrospective study also suggests that pregnant women receiving osteopathic manipulative treatment (OMT) may be at lower risk for pre-term delivery and the presence of meconium during delivery.
- Being tested
- Osteopathic manipulative treatment (OMT)
- Keywords
- Randomized Controlled Trial, Pregnant Women
- Medical subject headings
- Low Back Pain, Musculoskeletal Diseases, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatment (OMT)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale for pain, Roland-Morris Disability Questionnaire, and SF-12 Health Status Survey during third trimester of pregnancy and continuing six weeks post-partum
Secondary outcomes (1)
Occurrence of premature labor and delivery as well as obstetrical complications during delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startJul 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 146 participants
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- Osteopathic Heritage Foundations
- Investigators
- John C. Licciardone, D.O., M.S., Principal investigator, Osteopathic Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298935
- Sponsor's protocol ID
- 20-102
- Status last verified
- Jun 2013
- First submitted
- 2 Mar 2006
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial of Osteopathic Manipulative Treatment (OMT) in Pregnancy
- ClinicalTrials.gov ID
- NCT00298935
- Acronym / sponsor ID
- 20-102
- Keywords
- Randomized Controlled Trial, Pregnant Women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- Osteopathic Heritage Foundations
- Study start
- Jul 2003
- Study completion
- Jun 2006 (actual)
- First posted
- 3 Mar 2006 (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 purpose of this study is to determine whether osteopathic manipulative treatment (OMT):
- decreases pain and improves physical functioning in women during the third trimester of pregnancy
- decreases complications during obstetrical delivery
- improves quality of life in the post-partum period
Detailed description
Women experience multiple changes in their anatomy and physiology during pregnancy that may cause pain and adversely affect quality of life. Additionally, about ten percent of women will experience signs and symptoms of pre-eclampsia or pre-term labor during their first pregnancy.
Preliminary studies of osteopathic manipulative treatment (OMT) have demonstrated a decrease in pain during pregnancy, although the mechanisms responsible for this effect are unclear.
Another theory is that osteopathic manipulative treatment (OMT) may help normalize sympathetic outflow, thereby minimizing pregnancy complications. A recently published retrospective study also suggests that pregnant women receiving osteopathic manipulative treatment (OMT) may be at lower risk for pre-term delivery and the presence of meconium during delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Third trimester pregnancy
Key exclusion criteria (2 listed)
- High risk pregnancy
- Previous use of chiropractic manipulation, osteopathic manipulative treatment (OMT), physical therapy, or therapeutic ultrasound during the current pregnancy
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 |
|---|---|---|
| Osteopathic manipulative treatment (OMT) | Procedure or surgery | – |
Primary outcome
Visual analogue scale for pain, Roland-Morris Disability Questionnaire, and SF-12 Health Status Survey during third trimester of pregnancy and continuing six weeks post-partum
1 secondary outcome
Occurrence of premature labor and delivery as well as obstetrical complications during delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
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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.
John C. Licciardone, D.O., M.S. principal investigator
Osteopathic Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osteopathic manipulative treatment (OMT) in people with Low Back Pain and Musculoskeletal Diseases, run by University of North Texas Health Science Center at 1 site 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual analogue scale for pain, Roland-Morris Disability Questionnaire, and SF-12 Health Status Survey during third trimester of pregnancy and continuing six weeks post-partum. 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 24 Jun 2013.