Chiropractic Manipulation and Medical Care for Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211613
• Other study ID #: PRO10040327
• Secondary ID: 4R00AT004196-03
• Status: Completed
• Phase: N/A
• First received: September 28, 2010
• Last updated: November 18, 2014
• Start date: November 2010
• Est. completion date: October 2013

Study information

• Verified date: November 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: October 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• Manual Manipulation
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.

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

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center: Center for Integrative Medicine	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	University of Western States

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schneider MJ, Brach J, Irrgang JJ, Abbott KV, Wisniewski SR, Delitto A. Mechanical vs manual manipulation for low back pain: an observational cohort study. J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):193-200. doi: 10.1016/j.jmpt.2010.01.010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4 weeks (post treatment)	No
Secondary	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).	4 weeks (post treatment)	No