Chiropractic Manipulation and Medical Care for Low Back Pain

University of Pittsburgh

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Standard Medical Care; Device: Mechanically-assisted manipulation; Procedure: Manual Manipulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01211613

4R00AT004196-03 (U.S. NIH Grant/Contract)

PRO10040327

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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107 participants in 3 patient groups

Manual Manipulation

Experimental group

Description:

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

Treatment:

Procedure: Manual Manipulation

Mechanical Manipulation

Experimental group

Description:

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

Treatment:

Device: Mechanically-assisted manipulation

Standard Medical Care

Active Comparator group

Description:

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.

Treatment:

Other: Standard Medical Care