AzTrials
AzTrials

Low Back PainPhase 2NCT00937365

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

A Phase 2 study testing Exercise, Spinal Manipulation and Neuroemotional Technique (NET) in people with Low Back Pain, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Low Back Pain
What is being tested?
Exercise, Spinal Manipulation and Neuroemotional Technique (NET)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
Jul 2009to Apr 2012
Phase
Phase 2
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 20 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Low Back Pain
Being tested
Exercise, Spinal Manipulation, Neuroemotional Technique (NET)
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
Medical subject headings
Low Back Pain, Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Also called pelvic tilts, stretch, strengthen, glut squeeze

    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 ManipulationProcedure or surgery

    Also called SMT, CMT, chiropractic manipulative therapy, OMT

    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)Procedure or surgery

    Also called NET, Mind-body therapy

    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.

Study groups in NCT00937365
Study groupRoleWhat they receive
ExerciseActive comparatorSpecific 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.
Receives: Behavioral: Exercise
Spinal ManipulationExperimentalWomen 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.
Receives: Procedure: Spinal Manipulation
Neuroemotional technique (NET)ExperimentalNeuroemotional 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.
Receives: Procedure: Neuroemotional Technique (NET)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Roland Morris Disability Index

    Measured: Last study visit prior to birth

Secondary outcomes (1)

  1. Pain Visual Analog Scale

    Measured: Last Study Visit Before Birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00937365
Sponsor's protocol ID
5033
Status last verified
Dec 2019
First submitted
10 Jul 2009
Last updated
18 Dec 2019
Results posted
No
Data monitoring committee
No

Publications

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

    PubMed 11794714

  • 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.

    PubMed 15725792

  • 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.

    PubMed 17224825

  • 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.

    PubMed 16305268

  • 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.

    PubMed 15189474

  • 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.

    PubMed 16540862

  • 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.

    PubMed 16752254

  • 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.

    PubMed 15759172

  • 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.

    PubMed 1866363

  • 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.

    PubMed 18722200

  • 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.

    PubMed 15919579

  • 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.

    PubMed 22694756

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exercise, Spinal Manipulation and Neuroemotional Technique (NET) in people with Low Back Pain, run by Oregon Health and Science University 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 5 inclusion and 5 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 18 Dec 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Disability Index (time frame: Last study visit prior to birth). 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 NCT00937365, which also lists 12 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 18 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in