The Mechanisms of Manual Therapy in the Treatment of Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01168999
First received: July 22, 2010
Last updated: January 7, 2014
Last verified: November 2013
Results First Received: May 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Other: spinal manipulation
Other: sham spinal manipulation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Spinal Manipulative Therapy Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Sham Spinal Manipulative Therapy Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Enhanced Sham Spinal Manipulative Therapy 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.
Natural History These participants sat quietly for 5 minutes during the initial and final testing sessions.

Participant Flow:   Overall Study
    Spinal Manipulative Therapy     Sham Spinal Manipulative Therapy     Enhanced Sham Spinal Manipulative Therapy     Natural History  
STARTED     28     27     27     28  
COMPLETED     26     26     27     28  
NOT COMPLETED     2     1     0     0  
Lost to Follow-up                 2                 1                 0                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Spinal Manipulative Therapy Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
Sham Spinal Manipulative Therapy Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
Enhanced Sham Spinal Manipulative Therapy 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.
Natural History These participants sat quietly for 5 minutes during the initial and final testing sessions.
Total Total of all reporting groups

Baseline Measures
    Spinal Manipulative Therapy     Sham Spinal Manipulative Therapy     Enhanced Sham Spinal Manipulative Therapy     Natural History     Total  
Number of Participants  
[units: participants]
  28     27     27     28     110  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     28     27     27     28     110  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.07  ± 10.98     33.22  ± 13.29     31.56  ± 11.85     29.85  ± 12.09     31.68  ± 11.85  
Gender  
[units: participants]
         
Female     21     17     20     19     77  
Male     7     10     7     9     33  
Region of Enrollment  
[units: participants]
         
United States     28     27     27     28     110  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Believability of Placebo   [ Time Frame: baseline ]

2.  Primary:   Expectation for Treatment Effectiveness   [ Time Frame: baseline ]

3.  Primary:   Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale   [ Time Frame: Change from Baseline at 2 weeks ]

4.  Primary:   Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index   [ Time Frame: Change from Baseline at 2 weeks ]

5.  Primary:   Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale   [ Time Frame: baseline and immediately following their assigned intervention during the initial session ]

6.  Secondary:   Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion   [ Time Frame: Change from Baseline at 2 weeks ]

7.  Secondary:   Change From Baseline at 2 Weeks in Low Back Extension Range of Motion   [ Time Frame: Change from Baseline at 2 weeks ]

8.  Secondary:   Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion   [ Time Frame: Change from Baseline at 2 weeks ]

9.  Secondary:   Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion   [ Time Frame: Change from Baseline at 2 weeks ]


  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
  Hide More Information

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


Results Point of Contact:  
Name/Title: Dr. Joel Bialosky
Organization: University of Florida
phone: 352-273-8636
e-mail: bialosky@phhp.ufl.edu


No publications provided by University of Florida

Publications automatically indexed to this study:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01168999     History of Changes
Other Study ID Numbers: 345-2009
Study First Received: July 22, 2010
Results First Received: May 10, 2013
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board