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

NCT02123394 | Completed

• 1 other identifier: FAPESP200755
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-specific Chronic Low Back Pain

Keywords

Low Back Pain; Mechanical Low Back Pain; Low Back Ache; Low Backache; Lower Back Pain; Lumbago

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Pain Intensity

  3, 6 and 12 months after randomization

• Disability

  3, 6 and 12 months after randomization

• Function

  Five weeks, 3, 6 and 12 months after randomization

• Kinesiophobia

  Five weeks, 3, 6 and 12 months after randomization

• Global perceived effect

  Five weeks, 3, 6 and 12 months after randomization

Other Outcomes (1)

• Patient's expectancy for improvement

  Baseline

Study Arms (2)

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).

Other: Placebo

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).

Other: McKenzie method

Interventions

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).

Also known as: Placebo effect, Nocebo effect

Placebo

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).

Also known as: McKenzie

McKenzie method

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Universidade Cidade de Sao Paulo

São Paulo, São Paulo, 03071-000, Brazil

Location

Related Publications (2)

• 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.

  PMID: 28701365 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.

  PMID: 25278336 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Placebo Effect; Nocebo Effect

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Leonardo OP Costa, PhD

  Universidade Cidade de São Paulo

  PRINCIPAL INVESTIGATOR

• Luciola CM Costa, PhD

  Universidade Cidade de São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 25, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

BR (1)