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

Non-specific Chronic Low Back Pain Clinical Trial

— Mckenzie  

Official title:

Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain: A Randomized Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123394
• Other study ID #: FAPESP200755
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: June 9, 2016
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-specific Chronic Low Back Pain

Intervention

Other:
• Placebo
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).
• McKenzie 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).

Locations

Country	Name	City	State
Brazil	Universidade Cidade de Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient's expectancy for improvement	Will be assessed by the Expectancy of Improvement Numerical Scale.	Baseline	No
Primary	Pain Intensity	Pain Intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS)	5 weeks after randomization	No
Primary	Disability	Disability will be measured by the 24-item Roland Morris Disability Questionnaire	Five weeks after randomization	No
Secondary	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	No
Secondary	Disability	Disability will be measured by the 24-item Roland Morris Disability Questionnaire	3, 6 and 12 months after randomization	No
Secondary	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	No
Secondary	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	No
Secondary	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	No