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NCT Number: NCT01211613

Chiropractic Manipulation and Medical Care for Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center: Center for Integrative Medicine

Pittsburgh, Pennsylvania, 15232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

manual manipulation

Procedure

Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.

Mechanically-assisted manipulation

Device

Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.

Other names: Activator IV Instrument: FDA approval# K003185

Standard Medical Care

Other

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.

Primary outcomes

  1. 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

  1. Numeric Pain Rating Score.

    Time frame: 4 weeks (post treatment)

    Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating "no pain" and 10 indicating "unbearable pain". Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment).

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 29, 2010
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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