Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-26 @ 11:53 PM
Study NCT ID:
NCT02517606
Status:
UNKNOWN
Last Update Posted:
2018-11-06
First Post:
2015-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hip Posterolateral Complex Strengthening in Patients With Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial
Sponsor:
Federal University of Bahia
Organization:
Study Overview
Official Title:
Hip Posterolateral Complex Strengthening in Patients With Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Chronic nonspecific low back pain is an important health condition with a high prevalence worldwide and it is associated with enormous direct and indirect costs to the society. Clinical practice guidelines show that many interventions are available to treat patients with chronic low back pain, but the vast majority of these interventions have a modest effect in reducing pain and disability. A biomechanical approach that has been raised is that a weakness of the hip abductors, extensors, and lateral rotators musculature (posterolateral complex - PLC) would lead to excessive contralateral pelvic drop during weight-bearing activities such as walking, running, climbing up or downstairs, generating an overload in the lumbar area. Although the strengthening of the hip PLC is largely used in clinical practice for treating patients with hip and knee injuries, there is still a lack of evidence regarding patients with low back pain. Therefore, questions remain about the efficacy of the hip dynamic stabilization as an additional intervention to conventional treatment in a well design trial with statistic power.
Detailed Description:
Randomised clinical trial will be held in following the recommendations of the CONSORT (Consolidated Standards of Reporting Trials). Will be recruited participants of both genders, aged between 18 and 60 years, with and without chronic nonspecific low back pain for over 3 months without irradiation for lower limbs. Potential participants with chronic nonspecific low back pain will be referred by their doctors orthopedic surgeons and/or rheumatologists that will make all the assessments and routine exams, for example, Imaging tests, prescription drugs and referral to physical therapy care. The characteristics of participants will be collected through an evaluation form specially designed for this study. This assessment form will contain issues related to demographic and anthropometric data, plus information about the clinical picture of the participants, as for example the use of medications, physical activity level, educational level, prior history of back pain and duration of symptoms.The clinical outcomes will be obtained at the completion of treatment (6 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.
The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles.
Study Oversight
Has Oversight DMC:
True
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?: