Pregnancy-Related Low Back Pain and Complementary and Alternative Medicine (CAM) Treatment
NCT ID: NCT00937365
Last Updated: 2019-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2009-07-31
2012-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
49 Years
FEMALE
Yes
Sponsors
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The ONE Foundation
UNKNOWN
Oregon Health and Science University
OTHER
Responsible Party
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Principal Investigators
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Thomas Gregory, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health & Science University
Portland, Oregon, United States
Countries
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References
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Benarroch EE. Pain-autonomic interactions: a selective review. Clin Auton Res. 2001 Dec;11(6):343-9. doi: 10.1007/BF02292765.
Borg-Stein J, Dugan SA, Gruber J. Musculoskeletal aspects of pregnancy. Am J Phys Med Rehabil. 2005 Mar;84(3):180-92. doi: 10.1097/01.phm.0000156970.96219.48.
Brage S, Sandanger I, Nygard 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. doi: 10.1097/01.brs.0000251883.20205.26.
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. doi: 10.1111/j.1469-8986.2004.00187.x.
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. doi: 10.1097/01.brs.0000202559.41193.b2.
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. doi: 10.1080/00016340600607297.
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. doi: 10.1007/s00586-004-0712-6. 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. doi: 10.3109/15513819109064780.
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.
Wadhwa PD. Psychoneuroendocrine processes in human pregnancy influence fetal development and health. Psychoneuroendocrinology. 2005 Sep;30(8):724-43. doi: 10.1016/j.psyneuen.2005.02.004. Epub 2005 Apr 25.
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.
Other Identifiers
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5033
Identifier Type: -
Identifier Source: org_study_id