Chiropractic Manipulation and Medical Care for Low Back Pain

This study has been completed.
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: June 13, 2014
Last verified: June 2014
  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:


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: 107
Study Start Date: November 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 13, 2014
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 July 26, 2014