Pregnancy-Related Low Back Pain and Complementary and Alternative Medicine (CAM) Treatment

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ClinicalTrials.gov Identifier: NCT00937365

Recruitment Status : Unknown

Verified July 2009 by Oregon Health and Science University.
Recruitment status was: Recruiting

First Posted : July 13, 2009

Last Update Posted : July 22, 2010

Sponsor:

Collaborator:

The ONE Foundation

Information provided by:

Oregon Health and Science University

Study Description

Brief Summary:

This study compares three treatments for low back pain that started during pregnancy. The study hypothesizes that exercise, spinal manipulation, and a mind-body technique called neuroemotional technique (NET) equally affect pain intensity and disability associated with pregnancy-related low back pain. The study also hypothesizes that pain intensity and disability levels do not influence maternal heart rate variability (a measure of stress) and intrauterine attachment (a measure of relationship quality). Ten women will additionally provide blood and salivary oxytocin samples during pregnancy and periodically for three months after birth. These women and their babies will also be videotaped playing for 5 minutes at 2 weeks, 6 weeks, and 3 months postpartum.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Behavioral: Exercise Procedure: Spinal Manipulation Procedure: Neuroemotional Technique (NET)	Phase 2

Detailed Description:

Pregnancy-related low back pain is experienced by over half of all pregnant women. In the United States it is thought of as a normal constituent of pregnancy. However, in Europe low back pain associated with pregnancy is treated. In the United States pregnancy-related low back pain is thought to resolve with birth. However about 1/3 of women who experience pregnancy-related low back pain continue to experience back pain for one year postpartum. Those women whose low back pain persists into the postpartum period are more at risk of experiencing comorbidities such as postpartum depression.

In the extrauterine life maternal pain limits a mother's ability to securely attach with her child. Furthermore, interpretation of pain intensity is influenced by the type of attachment the individual has with her parents. Little is known how maternal pain may influence intrauterine attachment. Similarly, heart rate variability is influenced by pain and by spinal manipulation in non-pregnant populations. However, normal non-pregnant patterns of heart rate variability are altered during the second and third trimesters of pregnancy, and little is known about why this happens or what this means.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Pilot Randomized Controlled Trial for Complementary and Alternative Medicine Treatment of Pregnancy-Related Low Back Pain.
Study Start Date :	July 2009
Estimated Primary Completion Date :	December 2010
Estimated Study Completion Date :	March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Exercise Specific strengthening exercises demonstrated to improve pregnancy-related low back pain are taught to participants of this arm. Additionally, each participant will be evaluated and additional exercises will be prescribed relevant to her particular needs. Study participants of this arm are asked to perform the exercises at home at least once a day. Exercise is recorded in a diary. Participants follow the same study visit schedule as the two other arms.	Behavioral: Exercise Study visits follow the normal prenatal care schedule (once monthly until 28 weeks, twice monthly until 36 weeks, weekly thereafter). Additional study visits may be necessary if the pain is too intense and requires additional visits. Other Names: pelvic tilts stretch strengthen glut squeeze
Experimental: Spinal Manipulation Women randomized to this arm will be evaluated for spinal subluxations and, if appropriate, treated with chiropractic manipulation. Type of manipulation is determined by presentation. Woman may be manipulated with high velocity low amplitude thrust, blocking, activator, or other appropriate means of manipulating.	Procedure: Spinal Manipulation Study visits follow the normal prenatal care schedule (once monthly until 28 weeks, twice monthly until 36 weeks, weekly thereafter). Additional study visits may be necessary if the pain is too intense and requires additional visits. Other Names: SMT CMT chiropractic manipulative therapy OMT osteopathic manipulative therapy adjustment
Experimental: Neuroemotional technique (NET) Neuroemotional technique (NET) is a mind-body technique which combines elements of chiropractic medicine, Chinese medicine, and behavioral psychology. Muscle response testing, a form of functional neurology, and visceral somatic reflexes are used to ascertain whether the pain or dysfunction experienced by the participant has an emotional component. If an emotional component is present, it is identified and the original "triggering" occurrence is identified. The participant creates a snapshot of that original occurrence and while she holds that image in her mind spinal levels which innervate the associated organ are adjusted.	Procedure: Neuroemotional Technique (NET) Study visits follow the normal prenatal care schedule (once monthly until 28 weeks, twice monthly until 36 weeks, weekly thereafter). Additional study visits may be necessary if the pain is too intense and requires additional visits. Other Names: NET Mind-body therapy

Outcome Measures

Primary Outcome Measures :

Roland Morris Disability Index [ Time Frame: Last study visit prior to birth ]

Secondary Outcome Measures :

Pain Visual Analog Scale [ Time Frame: Last Study Visit Before Birth ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 49 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy
20-49 years old
Pregnant with a singleton
Low back pain began during pregnancy and has lasted more than one week
Low back pain is reproducible with palpation

Exclusion Criteria:

Health conditions such as hypertension, diabetes, cancer, thyroid condition etc.
Pain radiates below knee
Cannot read English
Plans to move away from Portland area during pregnancy
Not willing to be randomized to one of the three arms of the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937365

Contacts


Contact: Caroline D Peterson, DC, PhD	503-367-1172	petcarol@ohsu.edu
Contact: Thomas Gregory, MD	503-494-3107	gregoryt@ohsu.edu

Locations


United States, Oregon
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Caroline D Peterson, DC, PhD 503-367-1172 petcarol@ohsu.edu
Contact: Thomas Gregory, MD 503-494-3107 gregoryt@ohsu.edu
Sub-Investigator: Caroline D Peterson, DC, PhD
Principal Investigator: Thomas Gregory, MD

Sponsors and Collaborators

Oregon Health and Science University

The ONE Foundation

Investigators


Principal Investigator:	Thomas Gregory, MD	Oregon Health and Science University

More Information

Publications:

Benarroch EE. Pain-autonomic interactions: a selective review. Clin Auton Res. 2001 Dec;11(6):343-9. Review.

Borg-Stein J, Dugan SA, Gruber J. Musculoskeletal aspects of pregnancy. Am J Phys Med Rehabil. 2005 Mar;84(3):180-92. Review.

Brage S, Sandanger I, Nygård JF. Emotional distress as a predictor for low back disability: a prospective 12-year population-based study. Spine (Phila Pa 1976). 2007 Jan 15;32(2):269-74.

Depledge J, McNair PJ, Keal-Smith C, Williams M. Management of symphysis pubis dysfunction during pregnancy using exercise and pelvic support belts. Phys Ther. 2005 Dec;85(12):1290-300.

Dipietro JA, Irizarry RA, Costigan KA, Gurewitsch ED. The psychophysiology of the maternal-fetal relationship. Psychophysiology. 2004 Jul;41(4):510-20.

Hurwitz EL, Morgenstern H, Kominski GF, Yu F, Chiang LM. A randomized trial of chiropractic and medical care for patients with low back pain: eighteen-month follow-up outcomes from the UCLA low back pain study. Spine (Phila Pa 1976). 2006 Mar 15;31(6):611-21; discussion 622.

Mogren I. Perceived health, sick leave, psychosocial situation, and sexual life in women with low-back pain and pelvic pain during pregnancy. Acta Obstet Gynecol Scand. 2006;85(6):647-56.

Padua L, Caliandro P, Aprile I, Pazzaglia C, Padua R, Calistri A, Tonali P. Back pain in pregnancy: 1-year follow-up of untreated cases. Eur Spine J. 2005 Mar;14(2):151-4. Epub 2004 May 15.

Gartner JG. Thymic involution with loss of Hassall's corpuscles mimicking thymic dysplasia in a child with transfusion-associated graft-versus-host disease. Pediatr Pathol. 1991 May-Jun;11(3):449-56.

Stuber KJ, Smith DL. Chiropractic treatment of pregnancy-related low back pain: a systematic review of the evidence. J Manipulative Physiol Ther. 2008 Jul-Aug;31(6):447-54. doi: 10.1016/j.jmpt.2008.06.009. Review.

Wadhwa PD. Psychoneuroendocrine processes in human pregnancy influence fetal development and health. Psychoneuroendocrinology. 2005 Sep;30(8):724-43. Epub 2005 Apr 25. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Peterson CD, Haas M, Gregory WT. A pilot randomized controlled trial comparing the efficacy of exercise, spinal manipulation, and neuro emotional technique for the treatment of pregnancy-related low back pain. Chiropr Man Therap. 2012 Jun 13;20(1):18. doi: 10.1186/2045-709X-20-18.


Responsible Party:	Caroline Peterson, DC, PhD, MPH, CPM, OHSU
ClinicalTrials.gov Identifier:	NCT00937365 History of Changes
Other Study ID Numbers:	5033
First Posted:	July 13, 2009 Key Record Dates
Last Update Posted:	July 22, 2010
Last Verified:	July 2009

Keywords provided by Oregon Health and Science University:


Pregnancy Pain Low back pain Pubic symphysis pain CAM Complementary & Alternative Medicine Exercise Chiropractic Spinal manipulation Adjustments	Neuroemotional technique Mind body Mind body therapy Attachment Maternal Fetal relationship Intrauterine attachment Heart rate variability VAS Visual analog scale Roland Morris Disability Index

Additional relevant MeSH terms:


Back Pain Low Back Pain Pain	Neurologic Manifestations Nervous System Diseases Signs and Symptoms

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