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| Name | Class |
|---|---|
| The Danish Rheumatism Association | OTHER |
| The Danish Physiotherapy Organization. | UNKNOWN |
| Foundation for Chiropractic Research and Post Graduate Education | OTHER |
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Introduction:
The McKenzie method as well as spinal manipulation is commonly used for the treatment of low back pain throughout the western world. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of persistent symptoms originating from a diskus in the low back.
Methods:
After clinical screening 350 patients with or without leg pain who presented with centralization of symptoms or signs of disc herniation were randomized to the McKenzie group or the manipulation group. The outcome measures, Roland Morris Disability Questionnaire, 11 point numerical pain scale, 6 point global perceived change scale, and quality of life (Short Form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.
In 1998, Cherkin et al. published a study showing no difference between outcomes following the McKenzie method, chiropractic manipulation, or the provision of an educational booklet for the treatment of patients with acute non-specific low back pain. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of disc-related symptoms for duration of more than 6 Weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| McKenzie exercises | Experimental | McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy |
|
| Spinal manipulation | Active Comparator | Spinal manipulation in combination with information of clinical findings and advice about back care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal manipulation | Procedure | Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disability | Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points). | two months after treatment |
| Number of Patients With Treatment Success | Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points) | Two months posttreatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | The back and leg pain questionnaire included three separate 11 point box scales comprising the following items: Low Back Pain (LBP) at the moment, the worst LBP within the past two weeks, and the average level of LBP within the last two weeks. These summed to a total score ranging from 0 points (no back or leg pain at all) to 60 points (worst possible back and leg pain on all items). | twelve months posttreatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Petersen, PT,PhD | Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Back and Rehabilitation Center Copengagen | Copenhagen | Copenhagen OE | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25887046 | Derived | Petersen T, Christensen R, Juhl C. Predicting a clinically important outcome in patients with low back pain following McKenzie therapy or spinal manipulation: a stratified analysis in a randomized controlled trial. BMC Musculoskelet Disord. 2015 Apr 1;16:74. doi: 10.1186/s12891-015-0526-1. |
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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)
We recruited patients from September 2003 through May 2007 among those referred for treatment at a primary care specialist centre in Copenhagen, Denmark.
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| ID | Title | Description |
|---|---|---|
| FG000 | McKenzie Exercises | McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy |
| FG001 | Spinal Manipulation | Spinal manipulation in combination with information of clinical findings and advice about back care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | McKenzie Exercises | McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy |
| BG001 | Spinal Manipulation | Spinal manipulation in combination with information of clinical findings and advice about back care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disability | Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points). | Intention to treat | Posted | Mean | 95% Confidence Interval | Units on a scale | two months after treatment |
|
During the intervention which had a duration of maximum 3 months
Adverse events were collected by registration of patients referred to hospital by a rheumatologist due to signs and symptoms of spinal pathology. It is the judgment of the investigators that they were not likely to be provoked by the treatment itself, since treatment currently was guided by the patient's response of symptoms during treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | McKenzie Exercises | McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| herniated disc | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patients referred to hospital due to signs and symptoms of herniated disc by decision of a rheumatologist. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tom Petersen | Back and Rehabilitation Center Copenhagen | +45 35304974 | tom.petersen@suf.kk.dk |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| The Danish Institute for Mechanical Diagnosis and Therapy. |
| UNKNOWN |
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| McKenzie exercises | Procedure | McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy |
|
| Number of Patients on Sick Leave | Measured by self-report of beeing on sick leave at the moment because of LBP | twelve months posttreatment |
| Quality of Life | Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0) | twelve months posttreatment |
| Cost Effectiveness | twelve months posttreatment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number sick-listed | Number | participants |
|
| Duration of pain | Mean | Standard Deviation | Weeks |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Pain | The back and leg pain questionnaire included three separate 11 point box scales comprising the following items: Low Back Pain (LBP) at the moment, the worst LBP within the past two weeks, and the average level of LBP within the last two weeks. These summed to a total score ranging from 0 points (no back or leg pain at all) to 60 points (worst possible back and leg pain on all items). | Posted | Mean | 95% Confidence Interval | Units on a scale | twelve months posttreatment |
|
|
|
| Secondary | Number of Patients on Sick Leave | Measured by self-report of beeing on sick leave at the moment because of LBP | Number of patients on sick leave due to LBP pre-treatment. | Posted | Number | Participants | twelve months posttreatment |
|
|
|
| Secondary | Quality of Life | Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0) | Not Posted | Aug 2010 | Mean | 95% Confidence Interval | Units on a scale | twelve months posttreatment |
| Secondary | Cost Effectiveness | Not Posted | Aug 2010 | twelve months posttreatment |
| Primary | Number of Patients With Treatment Success | Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points) | Intention to treat | Posted | Number | participants | Two months posttreatment |
|
|
|
| 0 |
| 175 |
| 5 |
| 175 |
| EG001 | Spinal Manipulation | Spinal manipulation in combination with information of clinical findings and advice about back care | 0 | 175 | 9 | 175 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |