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Clinical Trials/NCT01211613
NCT01211613
Completed
Not Applicable

A Comparison of Chiropractic Manipulation Methods and Standard Medical Care for Low Back Pain

University of Pittsburgh1 site in 1 country107 target enrollmentNovember 2010
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
University of Pittsburgh
Enrollment
107
Locations
1
Primary Endpoint
Oswestry Low Back Pain Disability Index
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
October 2013
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Schneider, DC, PhD

DC, PhD

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Age: ≥ 18 years of age
  • Ability to read and write English
  • Experiencing a new episode of low back pain (LBP) 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

Outcomes

Primary Outcomes

Oswestry Low Back Pain Disability Index

Time Frame: 4 weeks (post treatment)

The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).

Secondary Outcomes

  • Numeric Pain Rating Score.(4 weeks (post treatment))

Study Sites (1)

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