Clinical trial NCT02517606: Hip Posterolateral Complex Strengthening in Patients With Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial
Official title: Hip Posterolateral Complex Strengthening in Patients With Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Low Back Pain
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado da Bahia
First posted: 2015-08-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* • Will be included 70 patients of both sexes, adults with medical diagnosis divided into two groups: Group A consisted of 35 patients use receive conventional physical therapy plus the addition of hip PLC strengthening and group B consisted of 35 patients also only use conventional physical therapy

Exclusion Criteria:

* Will be excluded from the study patients who have neurological or osteoarticular disease preventing the ambulation of these individuals.

Primary outcomes:
measure: Pain
timeFrame: 6 weeks
measure: Disability
timeFrame: 6 weeks
Secondary outcomes:
measure: Strength
timeFrame: 6 weeks
measure: Functioning (activities and participation)
timeFrame: 6 weeks
measure: Movement analysis with a 2-D system
timeFrame: 6 weeks
Other outcomes:
measure: Pain
timeFrame: 6 months
measure: Disability
timeFrame: 6 months
measure: Functioning (activities and participation)
timeFrame: 6 months
Locations:
city: Salvador
country: Brazil
facility: Mansueto Gomes Neto
state: Bahia
Study officials:
affiliation: UFBA
name: Mansueto G Neto
role: PRINCIPAL_INVESTIGATOR
References: