Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-07 @ 3:52 PM
Study NCT ID:
NCT02123394
Status:
COMPLETED
Last Update Posted:
2016-06-10
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain
Sponsor:
Universidade Cidade de Sao Paulo
Organization:
Study Overview
Official Title:
Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain: A Randomized Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mckenzie
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: