Chiropractic Manipulation and Medical Care for Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: Manual Manipulation; Device: Mechanically-assisted manipulation; Other: Standard Medical Care

• Registration Number: NCT01211613
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Study Start: 2010-11
• Primary Completion: 2013-03
• Study Completion: 2013-10
• Results First Submitted: 2014-11-05
• Results First Submitted QC: 2014-11-18
• Results First Posted: 2014-11-24
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Manipulation	Manual Manipulation	Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Mechanical Manipulation	Mechanically-assisted manipulation	Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Standard Medical Care	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.

Primary Outcome Measures

Name	Time	Method
Oswestry Low Back Pain Disability Index	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 Outcome Measures

Name	Time	Method
Numeric Pain Rating Score.	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).

Trial Locations

Locations (1)

University of Pittsburgh Medical Center: Center for Integrative Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States