NCT00410397

Brief Summary

Low back pain (LBP) is a common problem in the adult population with many approaches to treatment, but no clear answer. One of the causes of LBP, musculoskeletal pain, can be triggered by spasm of the deep muscles of the back and pelvis. This study, therefore, focuses on treating pelvic muscle pain as a way of lessening LBP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Dec 2006

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

Enrollment Period

2 months

First QC Date

December 11, 2006

Last Update Submit

January 8, 2008

Conditions

Low Back PainPain

Keywords

Low back painHip pain

Outcome Measures

Primary Outcomes (1)

  • Reduction in low back pain on a 1-10 scale.

    Immediately following treatment.

Secondary Outcomes (2)

  • Reduction in low back pain on a 0-10 scale.

    6-8 hours after treatment.

  • Reduction in low back pain on a 0-10 scale.

    After four weeks of therapy.

Study Arms (2)

A

EXPERIMENTAL

Osteopathic Manipulative Medicine

Procedure: Osteopathic Manipulative Medicine

B

PLACEBO COMPARATOR
Procedure: Sham Manipulation

Interventions

Osteopathic Manipulative MedicinePROCEDURE

Pelvic balancing, myofascial release of the anterior pelvis.

A
Sham ManipulationPROCEDURE

Neutral positional, gentle palpation

B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • Age-older than 18 years and younger than 65 years
  • Lumbopelvic pain

You may not qualify if:

  • Cardiovascular disease (heart-failure, myocardial infarction, hypertension)
  • Diabetes
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Chronic Illness
  • Pregnancy-self reported
  • Neurodegenerative Disease
  • Osteopenia
  • Osteoporosis
  • Metastatic Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma State University College of Osteopathic Medicine

Tulsa, Oklahoma, 74107, United States

Location

Related Publications (6)

  • Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.

    PMID: 16595438BACKGROUND

  • Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.

    PMID: 16080794BACKGROUND

  • Borenstein DG. Epidemiology, etiology, diagnostic evaluation, and treatment of low back pain. Curr Opin Rheumatol. 2001 Mar;13(2):128-34. doi: 10.1097/00002281-200103000-00006.

    PMID: 11224737BACKGROUND

  • Hestbaek L, Leboeuf-Yde C, Kyvik KO. Is comorbidity in adolescence a predictor for adult low back pain? A prospective study of a young population. BMC Musculoskelet Disord. 2006 Mar 16;7:29. doi: 10.1186/1471-2474-7-29.

    PMID: 16539740BACKGROUND

  • Hestbaek L, Larsen K, Weidick F, Leboeuf-Yde C. Low back pain in military recruits in relation to social background and previous low back pain. A cross-sectional and prospective observational survey. BMC Musculoskelet Disord. 2005 May 26;6:25. doi: 10.1186/1471-2474-6-25.

    PMID: 15918894BACKGROUND

  • Porter JL, Wilkinson A. Lumbar-hip flexion motion. A comparative study between asymptomatic and chronic low back pain in 18- to 36-year-old men. Spine (Phila Pa 1976). 1997 Jul 1;22(13):1508-13; discussion 1513-4. doi: 10.1097/00007632-199707010-00017.

    PMID: 9231971BACKGROUND

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Corey R Babb, B.A.

    Oklahoma State University College of Osteopathic Medicine

    PRINCIPAL INVESTIGATOR

  • JoAnn G Ryan, D.O.

    Oklahoma State University College of Osteopathic Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 12, 2006

Study Start

December 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

US(1)