The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborators:
The Danish Rheumatism Association
The Danish Physiotherapy Organization.
Foundation for Chiropractic Research and Post Graduate Education
The Danish Institute for Mechanical Diagnosis and Therapy.
Information provided by:
Back and Rehabilitation Center, Copenhagen
ClinicalTrials.gov Identifier:
NCT00939107
First received: July 13, 2009
Last updated: November 9, 2009
Last verified: November 2009
Results First Received: August 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Procedure: spinal manipulation
Procedure: McKenzie exercises

  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 patients from September 2003 through May 2007 among those referred for treatment at a primary care specialist centre in Copenhagen, Denmark.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1969 Patients were screened for eligibility. 1619 Were excluded (580 Were unable to speak and understand Danish, 252 Had comorbidity, 224 Had no peripheralization or centralization, 101 Had previous surgery, 87 Could not be examined, 165 other reasons, 210 Declined to participate)

Reporting Groups
  Description
McKenzie Exercises McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
Spinal Manipulation Spinal manipulation in combination with information of clinical findings and advice about back care

Participant Flow:   Overall Study
    McKenzie Exercises     Spinal Manipulation  
STARTED     175     175  
12 Months Follow-up     161     163  
COMPLETED     161     163  
NOT COMPLETED     14     12  
Lost to Follow-up                 14                 12  



  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.
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Reporting Groups
  Description
McKenzie Exercises McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
Spinal Manipulation Spinal manipulation in combination with information of clinical findings and advice about back care
Total Total of all reporting groups

Baseline Measures
    McKenzie Exercises     Spinal Manipulation     Total  
Number of Participants  
[units: participants]
  175     175     350  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     175     175     350  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38  ± 10.4     37  ± 9.4     37  ± 6.5  
Gender  
[units: participants]
     
Female     103     92     195  
Male     72     83     155  
Region of Enrollment  
[units: participants]
     
Denmark     175     175     350  
Number sick-listed  
[units: participants]
     
Number of patients on sick leave due to LBP     65     47     112  
Number of patients not on sick leave due to LBP     110     128     238  
Duration of pain  
[units: Weeks]
Mean ± Standard Deviation
  97  ± 230     94  ± 181     95  ± 210  



  Outcome Measures
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1.  Primary:   Disability   [ Time Frame: two months after treatment ]

2.  Primary:   Number of Patients With Treatment Success   [ Time Frame: Two months posttreatment ]

3.  Secondary:   Pain   [ Time Frame: twelve months posttreatment ]

4.  Secondary:   Number of Patients on Sick Leave   [ Time Frame: twelve months posttreatment ]

5.  Secondary:   Quality of Life   [ Time Frame: twelve months posttreatment ]
Results not yet posted.   Anticipated Posting Date:   08/2010   Safety Issue:   No

6.  Secondary:   Cost Effectiveness   [ Time Frame: twelve months posttreatment ]
Results not yet posted.   Anticipated Posting Date:   08/2010   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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: Tom Petersen
Organization: Back and Rehabilitation Center Copenhagen
phone: +45 35304974
e-mail: tom.petersen@suf.kk.dk


No publications provided


Responsible Party: Tom Petersen, research physical therapist, Back and Rehabilitation Center, Copenhagen
ClinicalTrials.gov Identifier: NCT00939107     History of Changes
Other Study ID Numbers: KF-01-057/03
Study First Received: July 13, 2009
Results First Received: August 13, 2009
Last Updated: November 9, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics