Non-specific Chronic Low Back Pain
Conditions
Keywords
Low Back Pain, Mechanical Low Back Pain, Low Back Ache, Low Backache, Lower Back Pain, Lumbago
Brief summary
The purpose of this study is to assess the efficacy of the McKenzie method in patients with chronic non-specific low back.
Detailed description
One hundred and forty-eight patients will be randomly allocated to two treatment groups: McKenzie method or Placebo (detuned ultrasound and short wave therapy) for 5 weeks (total of 10 sessions of 30 minutes each). The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated by constructing mixed linear models.
Interventions
OTHERPlacebo
The patients allocated to the Placebo group will be treated with detuned pulsed ultrasound therapy for 5 minutes and detuned short wave diathermy in pulsed mode for 25 minutes. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).
OTHERMcKenzie method
The patients of the McKenzie group will be treated according to the principles of the method and the choice of therapeutic intervention will be guided by the physical examination findings and classification. Patients will also receive written instructions from the Treat Your Own Back book and will be asked to perform home exercises based on the principles of McKenzie method. The description of the exercises that will be prescribed in this study are already published elsewhere. Compliance with home exercises will be monitored by means of a daily-log that the patient will fill in at home and bring to the therapist at each subsequent session. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
Universidade Cidade de Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 months), with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale, aged between 18 and 80 years and able to read in Portuguese. \-
Exclusion criteria
patients will be excluded if they have any contraindication to physical exercise or ultrasound or short wave therapy, evidence of nerve root compromise (i.e one or more of motor, reflex or sensation deficit), serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases), serious cardiovascular and metabolic diseases, previous back surgery and pregnancy. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability | Five weeks after randomization | Disability will be measured by the 24-item Roland Morris Disability Questionnaire |
| Pain Intensity | 5 weeks after randomization | Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 3, 6 and 12 months after randomization | Disability will be measured by the 24-item Roland Morris Disability Questionnaire |
| Function | Five weeks, 3, 6 and 12 months after randomization | Disability and function will be measured by an 11-point (0-10) Patient-Specific Functional Scale |
| Global perceived effect | Five weeks, 3, 6 and 12 months after randomization | Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale |
| Kinesiophobia | Five weeks, 3, 6 and 12 months after randomization | Kinesiophobia will be measured by the Tampa Scale of Kinesiophobia by means of 17 questions that deal with pain and intensity of symptoms. |
| Pain Intensity | 3, 6 and 12 months after randomization | Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient's expectancy for improvement | Baseline | Will be assessed by the Expectancy of Improvement Numerical Scale. |
Countries
Brazil
Outcome results
None listed