ClinicalTrials.gov
ClinicalTrials.gov Menu

Chiropractic Manipulation and Medical Care for Low Back Pain

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.
ClinicalTrials.gov Identifier: NCT01211613
Recruitment Status : Completed
First Posted : September 29, 2010
Results First Posted : November 24, 2014
Last Update Posted : January 30, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Michael Schneider, DC, PhD, University of Pittsburgh

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
Enrollment 107
Recruitment Details 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 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 Of the 40 patients randomized to Standard Medical Care, 3 never showed up for their first visit and 2 were withdrawn by the PI before receiving any treatments; leaving only 35 in that arm.
Arm/Group Title Manual Manipulation Mechanical Manipulation Standard Medical Care
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 37 35 35
Completed 34 33 33
Not Completed 3 2 2
Reason Not Completed
Lost to Follow-up             2             2             2
Withdrawal by Subject             1             0             0
Arm/Group Title Manual Manipulation Mechanical Manipulation Standard Medical Care Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 37 35 35 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 35 participants 35 participants 107 participants
41.4  (15.3) 40.4  (28.8) 41.3  (27.4) 41.1  (28.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 35 participants 35 participants 107 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 35 participants 35 participants 107 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%
1.Primary Outcome
Title Oswestry Low Back Pain Disability Index
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Manual Manipulation Mechanical Manipulation Standard Medical Care
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 37 35 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
-16.0  (14.1) -8.9  (11.9) -9.5  (14.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Manual Manipulation, Mechanical Manipulation, Standard Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments The p value above relates to the comparison of differences in baseline/4-week Oswestry change scores between manual and mechanical manipulation methods (primary hypothesis). A priori threshold for statistical significance was set at p < 0.05.
Method Regression, Linear
Comments Linear regression model was adjusted for these covariates: baseline Oswestry score, age, and treatment expectancy.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10
Parameter Dispersion
Type: Standard Deviation
Value: 14
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Numeric Pain Rating Score.
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Manual Manipulation Mechanical Manipulation Standard Medical Care
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 37 35 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.7  (1.5) -2.6  (1.6) -1.9  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Manual Manipulation, Mechanical Manipulation, Standard Medical Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The p value above relates to the comparison of differences in baseline/4-week Numeric pain change scores between manual and mechanical manipulation methods (secondary hypothesis). A priori threshold for statistical significance was set at p < 0.05.
Method Regression, Linear
Comments Linear regression model was adjusted for these covariates: baseline Numeric pain score, age, and treatment expectancy.
Time Frame Adverse event data were collected at each treatment visit in each of the 3 treatment arms, over the course of the entire 4-week treatment period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Manual Manipulation Mechanical Manipulation Standard Medical Care
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Manual Manipulation Mechanical Manipulation Standard Medical Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Manual Manipulation Mechanical Manipulation Standard Medical Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Manual Manipulation Mechanical Manipulation Standard Medical Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
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
EMail: mjs5@pitt.edu
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