Chiropractic Manipulation and Medical Care for Low Back Pain

University of Pittsburgh107 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

107

Conditions

Low Back Pain

Interventions

Manual ManipulationPROCEDURE

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

Mechanically-assisted manipulationDEVICE

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

Standard Medical CareOTHER

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pittsburgh Medical Center: Center for Integrative Medicine

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Oswestry Low Back Pain Disability Index

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).

Time frame: 4 weeks (post treatment)

Secondary Outcomes

Numeric Pain Rating Score.

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).

Time frame: 4 weeks (post treatment)

Data from ClinicalTrials.gov

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