Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the efficacy of the McKenzie method in patients with chronic non-specific low back.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The patients allocated to the Placebo group will be treated with detuned pulsed ultrasound 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). |
|
| McKenzie method | Experimental | 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. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS) | 5 weeks after randomization |
| Disability | Disability will be measured by the 24-item Roland Morris Disability Questionnaire | Five weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS) | 3, 6 and 12 months after randomization |
| Disability | Disability will be measured by the 24-item Roland Morris Disability Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's expectancy for improvement | Will be assessed by the Expectancy of Improvement Numerical Scale. | Baseline |
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.
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leonardo OP Costa, PhD | Universidade Cidade de São Paulo | Principal Investigator |
| Luciola CM Costa, PhD | Universidade Cidade de São Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Cidade de Sao Paulo | São Paulo | São Paulo | 03071-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28701365 | Derived | Garcia AN, Costa LDCM, Hancock MJ, Souza FS, Gomes GVFO, Almeida MO, Costa LOP. McKenzie Method of Mechanical Diagnosis and Therapy was slightly more effective than placebo for pain, but not for disability, in patients with chronic non-specific low back pain: a randomised placebo controlled trial with short and longer term follow-up. Br J Sports Med. 2018 May;52(9):594-600. doi: 10.1136/bjsports-2016-097327. Epub 2017 Jul 12. | |
| 25278336 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015990 | Placebo Effect |
| D064786 | Nocebo Effect |
| ID | Term |
|---|---|
| D015987 | Effect Modifier, Epidemiologic |
| D015981 | Epidemiologic Factors |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| McKenzie method | Other | 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). |
|
|
| 3, 6 and 12 months after randomization |
| Function | Disability and function will be measured by an 11-point (0-10) Patient-Specific Functional Scale | Five weeks, 3, 6 and 12 months after randomization |
| Kinesiophobia | Kinesiophobia will be measured by the Tampa Scale of Kinesiophobia by means of 17 questions that deal with pain and intensity of symptoms. | Five weeks, 3, 6 and 12 months after randomization |
| Global perceived effect | Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale | Five weeks, 3, 6 and 12 months after randomization |
| Derived |
| Garcia AN, Costa Lda C, Hancock MJ, de Almeida MO, de Souza FS, Costa LO. Efficacy of the McKenzie method in patients with chronic nonspecific low back pain: a protocol of randomized placebo-controlled trial. Phys Ther. 2015 Feb;95(2):267-73. doi: 10.2522/ptj.20140208. Epub 2014 Oct 2. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |