Low Back PainNCT00426244
Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects
A study testing Osteopathic Manipulative Treatment in people with Low Back Pain and Pregnancy, 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 to what extent and by what physiological mechanisms Osteopathic Manipulative Medicine (OMM) affects selected conditions related to pregnancy, labor and delivery. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Pregnancy
- What is being tested?
- Osteopathic Manipulative Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Sep 2011
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The woman must have medical clearance from her obstetrician at each study visit
- Must be less than or at 30 weeks gestation at the start of the study
Who cannot join
- Deemed high risk by the obstetrician (including but not limited to: abruptio placenta, placenta previa, severe pre-eclampsia/eclampsia, vaginal bleeding, gestational diabetes)
- Age 17 years or younger. Females 17 years of age and younger are considered pediatric high risk pregnancies and therefore ineligible for inclusion
- If a patient receives any other manual therapies such as massage, physical therapy, or chiropractic therapy, during the trial, she will be dropped from the study
- Subjects with a history of syncope either before or during this pregnancy will be excluded from participation in the substudy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Texas Health Science Center
Fort Worth, Texas, 76107
About this study
The purpose of this study is to determine to what extent and by what physiological mechanisms Osteopathic Manipulative Medicine (OMM) affects selected conditions related to pregnancy, labor and delivery.
Read the detailed description
The osteopathic philosophy of health is built on a model in which basic body functions are coordinated and integrated by the musculoskeletal system. Osteopathic medical students are taught to consider these aspects in assessing, diagnosing, and treating the individual patient. As a treatment method that reflects the osteopathic philosophy, osteopathic manipulative medicine (OMM) is a body-based modality in which the patient is evaluated and treated as a whole to improve physiologic functioning and remove impediments to optimal health and functioning.
During pregnancy, a woman's body is challenged by significant and extensive physiological and biomechanical changes. Some physiological changes, such as increased fluid volume and sympathetic tone, may lead to consequences such as edema, preterm labor, and meconium-staining of the amniotic fluid. The biomechanical state of the woman's body is also drastically affected; as the fetus grows and the uterus expands, the center of gravity shifts forward, rotating the pelvis anteriorly and increasing the lordosis of the low back, and may also affect the motion of the hips and legs. These postural changes also have consequences such as low back pain, decreased functional status, and altered gait. Both these physiologic and biomechanical consequences can have a significant long-term impact on the health of the mother and child.
OMM is theorized to facilitate the body's adjustment to the physiological and biomechanical demands of pregnancy and improve the outcomes of pregnancy, labor and delivery. Clinical case studies report reduced back pain, shorter labor, and fewer incidences of peripartum complications in patients who receive prenatal OMM. However, to date we have found no published systematic investigations of the efficacy of OMM in managing the adverse effects that pregnancy has on a woman's musculoskeletal system, nor have we found any published systematic studies to prove the mechanisms of action of OMM in managing pain, edema, or gait in pregnant patients.
Thus, the overall question that guides this proposal is: to what extent and by what physiological mechanisms does Osteopathic Manipulative Medicine (OMM) affect selected conditions related to pregnancy, labor and delivery? Based on the principles and theories of OMM and the limited previous studies, the hypothesis of this study is that OMM improves clinical outcomes including low back pain, functional status, incidence of meconium-stained amniotic fluid, and complications of labor and delivery, and that the physiological changes related to improved autonomic regulation, peripheral hemodynamic regulation, and biomechanical changes related to gait are, in part, responsible for these clinical benefits.
- Conditions
- Low Back Pain, Pregnancy
- Being tested
- Osteopathic Manipulative Treatment, Placebo Ultrasound
- Keywords
- Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment, Pregnancy, Physiologic, Gait, Low back pain, Heart rate variability
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
OMT is a complementary and alternative body-based treatment method in which the patient is evaluated and treated including the musculoskeletal system to improve physiologic functioning and remove impediments to optimal health and functioning.
Placebo UltrasoundOther
Also called Sham Ultrasound Therapy
In addition to controlling for physician attention during the treatment visit, the SUT used a nonfunctional ultrasound therapy unit that was modified for research purposes to provide both visible and auditory cues that could potentially elicit a placebo response. The physician provided the SUT by placing the applicator head over the subject's clothing and applying sufficient pressure for tactile stimulation of the skin and underlying tissues in the same anatomical distributions as would generally be addressed if the subject were being treated with OMT.
The subjects assigned to the UOBC only group did not receive any study treatments beyond conventional obstetrical care; however, they were expected to complete data collection forms on the same schedule as all other trial subjects.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Ultrasound | Sham comparator | In addition to controlling for physician attention during the treatment visit, the SUT used a nonfunctional ultrasound therapy unit that was modified for research purposes to provide both visible and auditory cues that could potentially elicit a placebo response. The physician provided the SUT by placing the applicator head over the subject's clothing and applying sufficient pressure for tactile stimulation of the skin and underlying tissues in the same anatomical distributions as would generally be addressed if the subject were being treated with OMT.
The subjects assigned to the UOBC only group did not receive any study treatments beyond conventional obstetrical care; however, they were expected to complete data collection forms on the same schedule as all other trial subjects. Receives: Other: Placebo Ultrasound |
| Osteopathic Manipulative Treatment | Active comparator | OMT is a complementary and alternative body-based treatment method in which the patient is evaluated and treated including the musculoskeletal system to improve physiologic functioning and remove impediments to optimal health and functioning. Receives: Other: Osteopathic Manipulative Treatment |
| Standard Care | No intervention | Subject only receives care from her OB provider. Subjects were allowed to receive conventional obstetrical care with the exception of OMT, massage therapy, physical therapy, chiropractic manipulation, or therapeutic ultrasound intended to treat musculoskeletal disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland-Morris Low Back Pain and Disability Questionnaire at each visit.
Measured: 5 years
Quadruple Visual Analog Scale at each visit.
Measured: 5 years
Ware's Short Form-12 (SF-12)at each visit.
Measured: 5 years
PHYSIOLOGICAL STUDY -All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
Measured: 5 years
Heart rate and blood pressure variability as measured by ECG and power spectral analysis.
Measured: 5 years
BIOMECHANICAL STUDY - All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
Measured: 5 years
Step length as measured by the GAITRite walkway.
Measured: 5 years
Foot angle of progression as measured by the GAITRite walkway.
Measured: 5 years
Gait Symmetry as measured by the GAITRite walkway.
Measured: 5 years
Secondary outcomes (15)
CLINICAL STUDY
Measured: 5 years
Subject Confidence in Treatment Assessment at visits 1,7,and 9.
Measured: 5 yers
Meconium staining of the amniotic fluid as recorded on the delivery record.
Measured: 5 years
Other outcomes of pregnancy, labor and delivery including incidence of high-risk status, incidence of pre-term labor, length of labor, use of forceps or suction device, and pain medication use as recorded in the prenatal and delivery record.
Measured: 5 years
PHYSIOLOGICAL STUDY-All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
Measured: 5 years
Heart rate as measured by ECG.
Measured: 5 years
Arterial pressure as measured by finger photoplethysmographic monitor.
Measured: 5 years
Respiration as measured by a strain gauge belt.
Measured: 5 years
Saphenous vein diameter and flow as measured by surface ultrasound.
Measured: 5 years
Calf muscle EMG as measured by surface electromyographic activity of the gastrocnemius
Measured: 5 years
Total leg volume as estimated by strain gauge plethysmography.
Measured: 5 years
Tissue water content as measured by surface dielectric probe.
Measured: 5 years
Venous flow rate as measured by calf plethysmography.
Measured: 5 years
BIOMECHANICAL STUDY -All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
Measured: 5 years
Gait cadence as measured by the GAITRite walkway.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startApr 2006
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (70)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), American Osteopathic Association, American Academy of Osteopathy, Med Ed Foundation of the Am Coll of Osteopathic Obstetricians & Gynecologists, Osteopathic Heritage Foundations
- Responsible party
- Principal investigator, Kendi Hensel, DO, PhD, University of North Texas Health Science Center
- Investigators
- Kendi Hensel, D.O., Ph.D., Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426244
- Sponsor's protocol ID
- K23AT003304-01A1
- Other IDs
- 5K23AT003304-05
- Status last verified
- Aug 2018
- First submitted
- 22 Jan 2007
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kristiansson P, Svardsudd K, von Schoultz B. Back pain during pregnancy: a prospective study. Spine (Phila Pa 1976). 1996 Mar 15;21(6):702-9. doi: 10.1097/00007632-199603150-00008.
PubMed 8882692Franklin ME, Conner-Kerr T. An analysis of posture and back pain in the first and third trimesters of pregnancy. J Orthop Sports Phys Ther. 1998 Sep;28(3):133-8. doi: 10.2519/jospt.1998.28.3.133.
PubMed 9742469Kristiansson P, Svardsudd K, von Schoultz B. Serum relaxin, symphyseal pain, and back pain during pregnancy. Am J Obstet Gynecol. 1996 Nov;175(5):1342-7. doi: 10.1016/s0002-9378(96)70052-2.
PubMed 8942512Daly JM, Frame PS, Rapoza PA. Sacroiliac subluxation: a common, treatable cause of low-back pain in pregnancy. Fam Pract Res J. 1991 Jun;11(2):149-59.
PubMed 1829312Lynch FW. The pelvic articulations during pregnancy, labor and the puerperium: An X-ray study. Surgery, Gynecology, and Obstetrics 30: 575-580, 1920.
Ostgaard HC, Andersson GB, Schultz AB, Miller JA. Influence of some biomechanical factors on low-back pain in pregnancy. Spine (Phila Pa 1976). 1993 Jan;18(1):61-5. doi: 10.1097/00007632-199301000-00010.
PubMed 8434326Treadwell RC, Magnus WW. Sacral shear: Review and a new treatment method for obstetricial patients. AAO Journal (Spring): 16-18, 1996.
Perkins J, Hammer RL, Loubert PV. Identification and management of pregnancy-related low back pain. J Nurse Midwifery. 1998 Sep-Oct;43(5):331-40. doi: 10.1016/s0091-2182(98)00032-9.
PubMed 9803711Heckman JD, Sassard R. Musculoskeletal considerations in pregnancy. J Bone Joint Surg Am. 1994 Nov;76(11):1720-30. doi: 10.2106/00004623-199411000-00018. No abstract available.
PubMed 7962034McIntyre IN, Broadhurst NA. Effective treatment of low back pain in pregnancy. Aust Fam Physician. 1996 Sep;25(9 Suppl 2):S65-7.
PubMed 8854409Brandy RE, Rottman J, Kappler RE, Veith EK. Forty first Annual AOA Research Conference Abstracts, 1997: Part 1: Osteopathic Manipulation to Treat Musculoskeletal Pain Associated with Pregnancy. JAOA 97(8): 479, 1997.
Diakow PR, Gadsby TA, Gadsby JB, Gleddie JG, Leprich DJ, Scales AM. Back pain during pregnancy and labor. J Manipulative Physiol Ther. 1991 Feb;14(2):116-8.
PubMed 1826921Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, Swift J Jr. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1355-62. doi: 10.1097/01.BRS.0000067110.61471.7D.
PubMed 12838090Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med. 1999 Nov 4;341(19):1426-31. doi: 10.1056/NEJM199911043411903.
PubMed 10547405MacDonald RS, Bell CM. An open controlled assessment of osteopathic manipulation in nonspecific low-back pain. Spine (Phila Pa 1976). 1990 May;15(5):364-70. doi: 10.1097/00007632-199005000-00005.
PubMed 2141951
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects
- ClinicalTrials.gov ID
- NCT00426244
- Acronym / sponsor ID
- K23AT003304-01A1
- Conditions
- Low Back Pain, Pregnancy
- Keywords
- Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment, Pregnancy, Physiologic, Gait, Low back pain, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), American Osteopathic Association, American Academy of Osteopathy, Med Ed Foundation of the Am Coll of Osteopathic Obstetricians & Gynecologists, Osteopathic Heritage Foundations
- Study start
- Apr 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Jan 2007 (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 to what extent and by what physiological mechanisms Osteopathic Manipulative Medicine (OMM) affects selected conditions related to pregnancy, labor and delivery.
Detailed description
The osteopathic philosophy of health is built on a model in which basic body functions are coordinated and integrated by the musculoskeletal system. Osteopathic medical students are taught to consider these aspects in assessing, diagnosing, and treating the individual patient. As a treatment method that reflects the osteopathic philosophy, osteopathic manipulative medicine (OMM) is a body-based modality in which the patient is evaluated and treated as a whole to improve physiologic functioning and remove impediments to optimal health and functioning.
During pregnancy, a woman's body is challenged by significant and extensive physiological and biomechanical changes. Some physiological changes, such as increased fluid volume and sympathetic tone, may lead to consequences such as edema, preterm labor, and meconium-staining of the amniotic fluid. The biomechanical state of the woman's body is also drastically affected; as the fetus grows and the uterus expands, the center of gravity shifts forward, rotating the pelvis anteriorly and increasing the lordosis of the low back, and may also affect the motion of the hips and legs. These postural changes also have consequences such as low back pain, decreased functional status, and altered gait. Both these physiologic and biomechanical consequences can have a significant long-term impact on the health of the mother and child.
OMM is theorized to facilitate the body's adjustment to the physiological and biomechanical demands of pregnancy and improve the outcomes of pregnancy, labor and delivery. Clinical case studies report reduced back pain, shorter labor, and fewer incidences of peripartum complications in patients who receive prenatal OMM. However, to date we have found no published systematic investigations of the efficacy of OMM in managing the adverse effects that pregnancy has on a woman's musculoskeletal system, nor have we found any published systematic studies to prove the mechanisms of action of OMM in managing pain, edema, or gait in pregnant patients.
Thus, the overall question that guides this proposal is: to what extent and by what physiological mechanisms does Osteopathic Manipulative Medicine (OMM) affect selected conditions related to pregnancy, labor and delivery? Based on the principles and theories of OMM and the limited previous studies, the hypothesis of this study is that OMM improves clinical outcomes including low back pain, functional status, incidence of meconium-stained amniotic fluid, and complications of labor and delivery, and that the physiological changes related to improved autonomic regulation, peripheral hemodynamic regulation, and biomechanical changes related to gait are, in part, responsible for these clinical benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Ultrasound | Sham comparator | Other: Placebo UltrasoundIn addition to controlling for physician attention during the treatment visit, the SUT used a nonfunctional ultrasound therapy unit that was modified for research purposes to provide both visible and auditory cues that could potentially elicit a placebo response. The physician provided the SUT by placing the applicator head over the subject's clothing and applying sufficient pressure for tactile stimulation of the skin and underlying tissues in the same anatomical distributions as would generally be addressed if the subject were being treated with OMT. The subjects assigned to the UOBC only group did not receive any study treatments beyond conventional obstetrical care; however, they were expected to complete data collection forms on the same schedule as all other trial subjects. |
| Osteopathic Manipulative Treatment | Active comparator | Other: Osteopathic Manipulative TreatmentOMT is a complementary and alternative body-based treatment method in which the patient is evaluated and treated including the musculoskeletal system to improve physiologic functioning and remove impediments to optimal health and functioning. |
| Standard Care | No intervention | –Subject only receives care from her OB provider. Subjects were allowed to receive conventional obstetrical care with the exception of OMT, massage therapy, physical therapy, chiropractic manipulation, or therapeutic ultrasound intended to treat musculoskeletal disorders. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The woman must have medical clearance from her obstetrician at each study visit
- Must be less than or at 30 weeks gestation at the start of the study
Key exclusion criteria (4 listed)
- Deemed high risk by the obstetrician (including but not limited to: abruptio placenta, placenta previa, severe pre-eclampsia/eclampsia, vaginal bleeding, gestational diabetes)
- Age 17 years or younger. Females 17 years of age and younger are considered pediatric high risk pregnancies and therefore ineligible for inclusion
- If a patient receives any other manual therapies such as massage, physical therapy, or chiropractic therapy, during the trial, she will be dropped from the study
- Subjects with a history of syncope either before or during this pregnancy will be excluded from participation in the substudy
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 TreatmentOMT is a complementary and alternative body-based treatment method in which the patient is evaluated and treated including the musculoskeletal system to improve physiologic functioning and remove impediments to optimal health and functioning. | Other | Osteopathic Manipulative Treatment |
| Placebo UltrasoundAlso: Sham Ultrasound TherapyIn addition to controlling for physician attention during the treatment visit, the SUT used a nonfunctional ultrasound therapy unit that was modified for research purposes to provide both visible and auditory cues that could potentially elicit a placebo response. The physician provided the SUT by placing the applicator head over the subject's clothing and applying sufficient pressure for tactile stimulation of the skin and underlying tissues in the same anatomical distributions as would generally be addressed if the subject were being treated with OMT. The subjects assigned to the UOBC only group did not receive any study treatments beyond conventional obstetrical care; however, they were expected to complete data collection forms on the same schedule as all other trial subjects. | Other | Placebo Ultrasound |
Primary outcome
Roland-Morris Low Back Pain and Disability Questionnaire at each visit.
Time frame: 5 years
Quadruple Visual Analog Scale at each visit.
Time frame: 5 years
Ware's Short Form-12 (SF-12)at each visit.
Time frame: 5 years
PHYSIOLOGICAL STUDY -All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
Time frame: 5 years
Heart rate and blood pressure variability as measured by ECG and power spectral analysis.
Time frame: 5 years
BIOMECHANICAL STUDY - All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
Time frame: 5 years
Step length as measured by the GAITRite walkway.
Time frame: 5 years
Foot angle of progression as measured by the GAITRite walkway.
Time frame: 5 years
Gait Symmetry as measured by the GAITRite walkway.
Time frame: 5 years
15 secondary outcomes
CLINICAL STUDY
Time frame: 5 years
Subject Confidence in Treatment Assessment at visits 1,7,and 9.
Time frame: 5 yers
Meconium staining of the amniotic fluid as recorded on the delivery record.
Time frame: 5 years
Other outcomes of pregnancy, labor and delivery including incidence of high-risk status, incidence of pre-term labor, length of labor, use of forceps or suction device, and pain medication use as recorded in the prenatal and delivery record.
Time frame: 5 years
PHYSIOLOGICAL STUDY-All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
Time frame: 5 years
Heart rate as measured by ECG.
Time frame: 5 years
Arterial pressure as measured by finger photoplethysmographic monitor.
Time frame: 5 years
Respiration as measured by a strain gauge belt.
Time frame: 5 years
Saphenous vein diameter and flow as measured by surface ultrasound.
Time frame: 5 years
Calf muscle EMG as measured by surface electromyographic activity of the gastrocnemius
Time frame: 5 years
Total leg volume as estimated by strain gauge plethysmography.
Time frame: 5 years
Tissue water content as measured by surface dielectric probe.
Time frame: 5 years
Venous flow rate as measured by calf plethysmography.
Time frame: 5 years
BIOMECHANICAL STUDY -All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
Time frame: 5 years
Gait cadence as measured by the GAITRite walkway.
Time frame: 5 years
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 21 Aug 2018.
- Background: PubMed 8882692Kristiansson P, Svardsudd K, von Schoultz B. Back pain during pregnancy: a prospective study. Spine (Phila Pa 1976). 1996 Mar 15;21(6):702-9. doi: 10.1097/00007632-199603150-00008.
- Background: PubMed 9742469Franklin ME, Conner-Kerr T. An analysis of posture and back pain in the first and third trimesters of pregnancy. J Orthop Sports Phys Ther. 1998 Sep;28(3):133-8. doi: 10.2519/jospt.1998.28.3.133.
- Background: PubMed 8942512Kristiansson P, Svardsudd K, von Schoultz B. Serum relaxin, symphyseal pain, and back pain during pregnancy. Am J Obstet Gynecol. 1996 Nov;175(5):1342-7. doi: 10.1016/s0002-9378(96)70052-2.
- Background: PubMed 1829312Daly JM, Frame PS, Rapoza PA. Sacroiliac subluxation: a common, treatable cause of low-back pain in pregnancy. Fam Pract Res J. 1991 Jun;11(2):149-59.
- BackgroundLynch FW. The pelvic articulations during pregnancy, labor and the puerperium: An X-ray study. Surgery, Gynecology, and Obstetrics 30: 575-580, 1920.
- Background: PubMed 8434326Ostgaard HC, Andersson GB, Schultz AB, Miller JA. Influence of some biomechanical factors on low-back pain in pregnancy. Spine (Phila Pa 1976). 1993 Jan;18(1):61-5. doi: 10.1097/00007632-199301000-00010.
- BackgroundTreadwell RC, Magnus WW. Sacral shear: Review and a new treatment method for obstetricial patients. AAO Journal (Spring): 16-18, 1996.
- Background: PubMed 9803711Perkins J, Hammer RL, Loubert PV. Identification and management of pregnancy-related low back pain. J Nurse Midwifery. 1998 Sep-Oct;43(5):331-40. doi: 10.1016/s0091-2182(98)00032-9.
- Background: PubMed 7962034Heckman JD, Sassard R. Musculoskeletal considerations in pregnancy. J Bone Joint Surg Am. 1994 Nov;76(11):1720-30. doi: 10.2106/00004623-199411000-00018. No abstract available.
- Background: PubMed 8854409McIntyre IN, Broadhurst NA. Effective treatment of low back pain in pregnancy. Aust Fam Physician. 1996 Sep;25(9 Suppl 2):S65-7.
- BackgroundBrandy RE, Rottman J, Kappler RE, Veith EK. Forty first Annual AOA Research Conference Abstracts, 1997: Part 1: Osteopathic Manipulation to Treat Musculoskeletal Pain Associated with Pregnancy. JAOA 97(8): 479, 1997.
- Background: PubMed 1826921Diakow PR, Gadsby TA, Gadsby JB, Gleddie JG, Leprich DJ, Scales AM. Back pain during pregnancy and labor. J Manipulative Physiol Ther. 1991 Feb;14(2):116-8.
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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.
Kendi Hensel, D.O., Ph.D. principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Low Back Pain and Pregnancy, 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 2 inclusion and 4 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 21 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
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?
Roland-Morris Low Back Pain and Disability Questionnaire at each visit. (time frame: 5 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00426244, which also lists 70 linked publications.
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 21 Aug 2018.