Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain

Universidade Cidade de Sao Paulo

Status: Completed

Conditions: Non-specific Chronic Low Back Pain

Treatments: Other: Placebo; Other: McKenzie method

Study type: Interventional

Funder types: Other

Identifiers

NCT02123394

FAPESP200755

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of the McKenzie method in patients with chronic non-specific low back.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo

McKenzie method

Experimental group

Description:

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).

Treatment:

Other: McKenzie method