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

Low Back Pain Clinical Trial

Official title:

A Pilot Randomized Controlled Trial for Complementary and Alternative Medicine Treatment of Pregnancy-Related Low Back Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937365
• Other study ID #: 5033
• Status: Completed
• Phase: Phase 2
• Start date: July 2009
• Est. completion date: April 2012

Study information

• Verified date: December 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	The ONE Foundation

Country where clinical trial is conducted

United States, 

References & Publications (11)

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

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland Morris Disability Index		Last study visit prior to birth
Secondary	Pain Visual Analog Scale		Last Study Visit Before Birth