Low Back Pain
Conditions
Keywords
low back pain, Intervertebral disc, McKenzie, Physical Therapy, Spinal manipulation, Chiropractics, Patient education, Exercise therapy, Random allocation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREspinal manipulation
Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care
PROCEDUREMcKenzie exercises
McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
Sponsors
The Danish Rheumatism Association
The Danish Physiotherapy Organization.
Foundation for Chiropractic Research and Post Graduate Education
The Danish Institute for Mechanical Diagnosis and Therapy.
Back and Rehabilitation Center, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 60 years of age * suffering from low back pain (LBP) with or without leg pain for a period of more than 6 weeks * able to speak and understand the Danish language * with a presentation of clinical signs of disc-related symptoms.
Exclusion criteria
* positive non-organic signs * serious pathology suspected based on physical examination and/or magnetic resonance imaging * application for disability pension or pending litigation * pregnancy * comorbidity * recent back surgery * problems with communication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability | two months after treatment | Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points). |
| Number of Patients With Treatment Success | Two months posttreatment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | twelve months posttreatment | Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0) |
| Pain | twelve months posttreatment | 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). |
| Number of Patients on Sick Leave | twelve months posttreatment | Measured by self-report of beeing on sick leave at the moment because of LBP |
| Cost Effectiveness | twelve months posttreatment | — |
Countries
Denmark
Participant flow
Recruitment details
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
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)
Participants by arm
| Arm | Count |
|---|---|
| McKenzie Exercises McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy | 175 |
| Spinal Manipulation Spinal manipulation in combination with information of clinical findings and advice about back care | 175 |
| Total | 350 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 12 |
Baseline characteristics
| Characteristic | McKenzie Exercises | Spinal Manipulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 175 Participants | 175 Participants | 350 Participants |
| Age Continuous | 38 years STANDARD_DEVIATION 10.4 | 37 years STANDARD_DEVIATION 9.4 | 37 years STANDARD_DEVIATION 6.5 |
| Duration of pain | 97 Weeks STANDARD_DEVIATION 230 | 94 Weeks STANDARD_DEVIATION 181 | 95 Weeks STANDARD_DEVIATION 210 |
| Number sick-listed Number of patients not on sick leave due to LBP | 110 participants | 128 participants | 238 participants |
| Number sick-listed Number of patients on sick leave due to LBP | 65 participants | 47 participants | 112 participants |
| Region of Enrollment Denmark | 175 participants | 175 participants | 350 participants |
| Sex: Female, Male Female | 103 Participants | 92 Participants | 195 Participants |
| Sex: Female, Male Male | 72 Participants | 83 Participants | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 175 | 9 / 175 |
| serious Total, serious adverse events | 0 / 175 | 0 / 175 |
Outcome results
Primary
Disability
Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).
Time frame: two months after treatment
Population: Intention to treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| McKenzie Exercises | Disability | 6.7 Units on a scale |
| Spinal Manipulation | Disability | 5.2 Units on a scale |
p-value: >0.0595% CI: [0.2, 2.8]t-test, 2 sided
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)
Time frame: Two months posttreatment
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| McKenzie Exercises | Number of Patients With Treatment Success | 120 participants |
| Spinal Manipulation | Number of Patients With Treatment Success | 95 participants |
Secondary
Cost Effectiveness
Time frame: 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
Time frame: twelve months posttreatment
Population: Number of patients on sick leave due to LBP pre-treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| McKenzie Exercises | Number of Patients on Sick Leave | 14 Participants |
| Spinal Manipulation | Number of Patients on Sick Leave | 6 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).
Time frame: twelve months posttreatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| McKenzie Exercises | Pain | 15.0 Units on a scale |
| Spinal Manipulation | Pain | 12.2 Units on a scale |
Secondary
Quality of Life
Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)
Time frame: twelve months posttreatment