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

NCT00937365 | Completed Phase 2

• 1 other identifier: 5033
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Roland Morris Disability Index

  Last study visit prior to birth

Secondary Outcomes (1)

• Pain Visual Analog Scale

  Last Study Visit Before Birth

Study Arms (3)

Exercise

ACTIVE COMPARATOR

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

Spinal Manipulation

EXPERIMENTAL

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

Neuroemotional technique (NET)

EXPERIMENTAL

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)

Interventions

Exercise BEHAVIORAL

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.

Also known as: pelvic tilts, stretch, strengthen, glut squeeze

Exercise

Spinal Manipulation PROCEDURE

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.

Also known as: SMT, CMT, chiropractic manipulative therapy, OMT, osteopathic manipulative therapy, adjustment

Spinal Manipulation

Neuroemotional Technique (NET) PROCEDURE

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.

Also known as: NET, Mind-body therapy

Neuroemotional technique (NET)

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• The ONE Foundation: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (12)

• Benarroch EE. Pain-autonomic interactions: a selective review. Clin Auton Res. 2001 Dec;11(6):343-9. doi: 10.1007/BF02292765.

  PMID: 11794714 BACKGROUND

• 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.

  PMID: 15725792 BACKGROUND

• 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.

  PMID: 17224825 BACKGROUND

• 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.

  PMID: 16305268 BACKGROUND

• 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.

  PMID: 15189474 BACKGROUND

• 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.

  PMID: 16540862 BACKGROUND

• 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.

  PMID: 16752254 BACKGROUND

• 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.

  PMID: 15759172 BACKGROUND

• 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.

  PMID: 1866363 BACKGROUND

• 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.

  PMID: 18722200 BACKGROUND

• 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.

  PMID: 15919579 BACKGROUND

• 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.

  PMID: 22694756 DERIVED

MeSH Terms

Conditions

Low Back Pain; Pain; Motor Activity

Interventions

Exercise; Manipulation, Spinal; Manipulation, Osteopathic; Mind-Body Therapies

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation; Complementary Therapies

Study Officials

• Thomas Gregory, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 13, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

US (1)