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Chiropractic Manipulation and Medical Care for Low Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01211613
First Posted: September 29, 2010
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Michael Schneider, DC, PhD, University of Pittsburgh
Results First Submitted: November 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Procedure: Manual Manipulation
Device: Mechanically-assisted manipulation
Other: Standard Medical Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We recruited 112 patients with a new episode of low back pain from the general population of the Greater Pittsburgh Metropolitan region. Recruitment took place during the period of time between November 2010 and April 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
197 patients were screened for potential eligibility. We excluded 85 patients for not meeting the inclusion criteria. Of the 40 patients randomized to Standard Medical Care, 3 never showed up for their first visit and 2 were withdrawn by the PI before receiving any treatments; leaving only 35 in that arm.

Reporting Groups
  Description
Manual Manipulation

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

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

Mechanical Manipulation

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

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

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.

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.


Participant Flow:   Overall Study
    Manual Manipulation   Mechanical Manipulation   Standard Medical Care
STARTED   37   35   35 
COMPLETED   34   33   33 
NOT COMPLETED   3   2   2 
Lost to Follow-up                2                2                2 
Withdrawal by Subject                1                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Manual Manipulation

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

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

Mechanical Manipulation

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

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

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.

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.

Total Total of all reporting groups

Baseline Measures
   Manual Manipulation   Mechanical Manipulation   Standard Medical Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   35   35   107 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.4  (15.3)   40.4  (28.8)   41.3  (27.4)   41.1  (28.8) 
Gender 
[Units: Participants]
Count of Participants
       
Female      25  67.6%      21  60.0%      21  60.0%      67  62.6% 
Male      12  32.4%      14  40.0%      14  40.0%      40  37.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      2   5.4%      0   0.0%      2   5.7%      4   3.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      9  24.3%      9  25.7%      11  31.4%      29  27.1% 
White      23  62.2%      22  62.9%      22  62.9%      67  62.6% 
More than one race      3   8.1%      4  11.4%      0   0.0%      7   6.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Oswestry Low Back Pain Disability Index   [ Time Frame: 4 weeks (post treatment) ]

2.  Secondary:   Numeric Pain Rating Score.   [ Time Frame: 4 weeks (post treatment) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael J Schneider, DC, PhD
Organization: University of Pittsburgh, Department of Physical Therapy`
phone: 412-383-6640
e-mail: mjs5@pitt.edu


Publications:

Responsible Party: Michael Schneider, DC, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01211613     History of Changes
Other Study ID Numbers: PRO10040327
4R00AT004196-03 ( U.S. NIH Grant/Contract )
First Submitted: September 28, 2010
First Posted: September 29, 2010
Results First Submitted: November 5, 2014
Results First Posted: November 24, 2014
Last Update Posted: January 30, 2017