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Chiropractic Manipulation and Medical Care for Low Back Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Western States
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01211613
First received: September 28, 2010
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

The investigators will be comparing the effectiveness of two types of chiropractic manipulation and standard medical care for patients with a recent onset of low back pain. The two types of chiropractic treatments being compared will be hands-on (manual) manipulation and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a medical examination and prescription for over-the-counter anti-inflammatory medication.


Condition Intervention
Low Back Pain
 Procedure: Manual Manipulation
Device: Mechanically-assisted manipulation
Other: Standard Medical Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Chiropractic Manipulation Methods and Standard Medical Care for Low Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Oswestry Low Back Pain Disability Index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Questionnaire of level of self-reported impairment of activity of daily living (ADLs)due to low back pain.


Secondary Outcome Measures:
  • Numeric Pain Rating Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Likert scale from 0-10 measuring self-reported level of low back pain.


Enrollment: 106
Study Start Date: November 2010
Estimated Study Completion Date: October 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual Manipulation
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
 Procedure: Manual Manipulation
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Experimental: Mechanical Manipulation
Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
 Device: Mechanically-assisted manipulation
Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.
Other Name: Activator IV Instrument: FDA approval# K003185
Active Comparator: Standard Medical Care
Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
 Other: Standard Medical Care
Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: ≥ 18 years of age
  • Ability to read and write English
  • Experiencing a new episode of low back pain with onset in the past 3 months
  • Oswestry Disability Index score between 20-70 points (0-100 scale)
  • Numeric pain rating score between 3-8 points (0-10 scale)

Exclusion Criteria:

  • Prior history of lumbar spine surgery
  • History of unstable spondylolisthesis, spinal stenosis, or scoliosis > 20°
  • Signs or symptoms suggestive of nerve root tension and/or neurological deficit in the lower extremity
  • History of metastatic cancer, osteoporosis, long-term corticosteroid use, or any other red flags of serious illness including the following: unexplained weight loss of >10% of body weight, spinal pain associated with fever, and severe night pain unrelieved by medication
  • Receiving any physical therapy, chiropractic therapy, or any other manual therapy for this episode of LBP (within the past 3 months)
  • Receiving any on-going medical care for this episode of low back pain
  • Current use of opiate or other prescription medications for low back pain
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211613

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center: Center for Integrative Medicine
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
University of Western States
Investigators
Principal Investigator: Michael J Schneider, PhD, DC University of Pittsburgh
  More Information

Publications:

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01211613     History of Changes
Other Study ID Numbers: PRO10040327, 4R00AT004196-03
Study First Received: September 28, 2010
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
Manipulation
Chiropractic
Low Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013