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The Mechanisms of Manual Therapy in the Treatment of 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: NCT01168999
Recruitment Status : Completed
First Posted : July 23, 2010
Results First Posted : December 23, 2013
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Other: spinal manipulation
Other: sham spinal manipulation
Other: Enhanced sham spinal manipulation
Enrollment 110
Recruitment Details The study was undertaken in a lab on the University of Florida. Participants were recruited through written and electronic advertisement approved by the University of Florida Institutional Review Board. The first participant was enrolled in the study in November of 2009 and the final participant completed the study in January of 2013.
Pre-assignment Details  
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks Received a sham spinal manipulative therapy for 6 sessions over 2 weeks. Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks. These participants sat quietly for 5 minutes during the initial and final testing sessions.
Period Title: Overall Study
Started 28 27 27 28
Completed 26 26 27 28
Not Completed 2 1 0 0
Reason Not Completed
Lost to Follow-up             2             1             0             0
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History Total
Hide Arm/Group Description Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks Received a sham spinal manipulative therapy for 6 sessions over 2 weeks. Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks. These participants sat quietly for 5 minutes during the initial and final testing sessions. Total of all reporting groups
Overall Number of Baseline Participants 28 27 27 28 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 27 participants 28 participants 110 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
27
 100.0%
27
 100.0%
28
 100.0%
110
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 27 participants 27 participants 28 participants 110 participants
32.07  (10.98) 33.22  (13.29) 31.56  (11.85) 29.85  (12.09) 31.68  (11.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 27 participants 28 participants 110 participants
Female
21
  75.0%
17
  63.0%
20
  74.1%
19
  67.9%
77
  70.0%
Male
7
  25.0%
10
  37.0%
7
  25.9%
9
  32.1%
33
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 27 participants 27 participants 28 participants 110 participants
28 27 27 28 110
1.Primary Outcome
Title Believability of Placebo
Hide Description Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description:
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed 28 27 27 0
Measure Type: Number
Unit of Measure: percentage of participants
67 37 78
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Expectation for Treatment Effectiveness
Hide Description how helpful participants expect the assigned intervention will be in decreasing their low back pain
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description:
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed 28 27 27 28
Measure Type: Number
Unit of Measure: percent expecting less pain
54 26 59 11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy, Natural History
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale
Hide Description A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain
Time Frame Change from Baseline at 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description:
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed 26 26 27 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.23  (14.01) 14.03  (17.88) 9.44  (25.90) 8.20  (12.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy, Natural History
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Repeated Measure ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index
Hide Description The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.
Time Frame Change from Baseline at 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description:
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed 26 26 27 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.46  (8.28) 2.08  (7.36) 2.69  (8.33) 2.54  (8.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy, Natural History
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Repeated Measure ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale
Hide Description Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating "no pain at all" and 100 mm indicating "the worst pain imaginable".
Time Frame baseline and immediately following their assigned intervention during the initial session
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description:
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed 28 27 27 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.14  (20.48) -3.04  (12.92) 1.22  (16.03) -2.93  (17.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy, Natural History
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Repeated Measure ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion
Hide Description Low back flexion range of motion was measured in degrees using a gravity inclinometer
Time Frame Change from Baseline at 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description:
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed 26 26 27 28
Mean (Standard Deviation)
Unit of Measure: degrees
1.58  (8.65) 2.67  (13.91) -0.33  (9.55) -0.54  (9.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spinal Manipulative Therapy, Sham Spinal Manipulative Therapy, Enhanced Sham Spinal Manipulative Therapy, Natural History
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Repeated Measure ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline at 2 Weeks in Low Back Extension Range of Motion
Hide Description Low back extension range of motion was measured in degrees using a gravity inclinometer
Time Frame Change from Baseline at 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description:
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed 26 26 27 28
Mean (Standard Deviation)
Unit of Measure: degrees
-1.50  (9.58) -0.07  (11.26) 1.26  (4.95) -0.21  (7.82)
8.Secondary Outcome
Title Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion
Hide Description Low back right sidebending range of motion was measured in degrees using a gravity inclinometer
Time Frame Change from Baseline at 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description:
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed 26 26 27 28
Mean (Standard Deviation)
Unit of Measure: degrees
0.92  (8.68) -0.19  (1.24) 0.63  (7.53) 0.50  (9.50)
9.Secondary Outcome
Title Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion
Hide Description Low back left sidebending range of motion was measured in degrees using a gravity inclinometer
Time Frame Change from Baseline at 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description:
Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
These participants sat quietly for 5 minutes during the initial and final testing sessions.
Overall Number of Participants Analyzed 26 26 27 28
Mean (Standard Deviation)
Unit of Measure: degrees
2.15  (8.04) -0.15  (6.37) 1  (6.66) -1.36  (6.41)
Time Frame The study was conducted from November of 2009 until January of 2013. The occurrence of adverse events was monitored during the length of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Hide Arm/Group Description Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks Received a sham spinal manipulative therapy for 6 sessions over 2 weeks. Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks. These participants sat quietly for 5 minutes during the initial and final testing sessions.
All-Cause Mortality
Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Spinal Manipulative Therapy Sham Spinal Manipulative Therapy Enhanced Sham Spinal Manipulative Therapy Natural History
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/27 (0.00%)   0/27 (0.00%)   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Joel Bialosky
Organization: University of Florida
Phone: 352-273-8636
EMail: bialosky@phhp.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01168999    
Other Study ID Numbers: 345-2009
First Submitted: July 22, 2010
First Posted: July 23, 2010
Results First Submitted: May 10, 2013
Results First Posted: December 23, 2013
Last Update Posted: October 28, 2015