Back to resultsChiropractic Manipulation and Medical Care for Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Manipulation
Mechanically-assisted manipulation
Standard Medical Care
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Manipulation, Chiropractic, Low Back Pain
Eligibility Criteria
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
Sites / Locations
- University of Pittsburgh Medical Center: Center for Integrative Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Manual Manipulation
Mechanical Manipulation
Standard Medical Care
Arm Description
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT01211613
First Posted
September 28, 2010
Last Updated
December 1, 2016
Sponsor
University of Pittsburgh
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01211613
Brief Title
Chiropractic Manipulation and Medical Care for Low Back Pain
Official Title
A Comparison of Chiropractic Manipulation Methods and Standard Medical Care for Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Manipulation, Chiropractic, Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Manipulation
Arm Type
Experimental
Arm Description
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Arm Title
Mechanical Manipulation
Arm Type
Experimental
Arm Description
Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Arm Title
Standard Medical Care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Manual Manipulation
Intervention Description
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Intervention Type
Device
Intervention Name(s)
Mechanically-assisted manipulation
Other Intervention Name(s)
Activator IV Instrument: FDA approval# K003185
Intervention Description
Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.
Intervention Type
Other
Intervention Name(s)
Standard Medical Care
Intervention 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.
Primary Outcome Measure Information:
Title
Oswestry Low Back Pain Disability Index
Description
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 Outcome Measure Information:
Title
Numeric Pain Rating Score.
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Schneider, PhD, DC
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center: Center for Integrative Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20350672
Citation
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.
Results Reference
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Chiropractic Manipulation and Medical Care for Low Back Pain
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