Hip Posterolateral Complex Strengthening in Patients With Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial

NCT ID: NCT02517606

Last Updated: 2018-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional physical therapy plus HPCS

Conventional physical therapy (Combination of manual therapy techniques and exercises for spinal segmental stabilization) plus the addition of hip posterolateral complex strengthening (HPCS)

Group Type EXPERIMENTAL

Conventional physical therapy plus HPCS

Intervention Type OTHER

Conventional physical therapy plus the addition of hip posterolateral complex strengthening

Conventional physical therapy

Conventional physical therapy (Combination of manual therapy techniques and exercises for spinal segmental stabilization)

Group Type ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type OTHER

Conventional physical therapy (combination of manual therapy techniques and exercises for spinal segmental stabilization)

Interventions

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Conventional physical therapy plus HPCS

Conventional physical therapy plus the addition of hip posterolateral complex strengthening

Intervention Type OTHER

Conventional physical therapy

Conventional physical therapy (combination of manual therapy techniques and exercises for spinal segmental stabilization)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado da Bahia

OTHER

Sponsor Role collaborator

Federal University of Bahia

OTHER

Sponsor Role lead

Responsible Party

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Mansueto Gomes Neto

Dr Mansueto Gomes Neto

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mansueto G Neto

Role: PRINCIPAL_INVESTIGATOR

UFBA

Locations

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Mansueto Gomes Neto

Salvador, Estado de Bahia, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Mansueto Gomes-Neto, PhD

Role: CONTACT

+557199188277

Mansueto Gomes-Neto

Role: CONTACT

+557132838910

Facility Contacts

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Mansueto G Neto, PhD

Role: primary

7132838910

Mansueto G Neto, PhD

Role: backup

Other Identifiers

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FUBahia LBP

Identifier Type: -

Identifier Source: org_study_id

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