Clinical trial NCT02123394: Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain
Official title: Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain: A Randomized Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Chronic Low Back Pain
Keywords: Low Back Pain
Mechanical Low Back Pain
Low Back Ache
Low Backache
Lower Back Pain
Lumbago
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-04-25
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

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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.

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Primary outcomes:
measure: Pain Intensity
timeFrame: 5 weeks after randomization
measure: Disability
timeFrame: Five weeks after randomization
Secondary outcomes:
measure: Pain Intensity
timeFrame: 3, 6 and 12 months after randomization
measure: Disability
timeFrame: 3, 6 and 12 months after randomization
measure: Function
timeFrame: Five weeks, 3, 6 and 12 months after randomization
measure: Kinesiophobia
timeFrame: Five weeks, 3, 6 and 12 months after randomization
measure: Global perceived effect
timeFrame: Five weeks, 3, 6 and 12 months after randomization
Other outcomes:
measure: Patient's expectancy for improvement
timeFrame: Baseline
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Cidade de Sao Paulo
state: SP
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Leonardo OP Costa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Cidade de São Paulo
name: Luciola CM Costa, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.