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

NCT02517606 | Unknown Phase 3 DMC

• 1 other identifier: FUBahia LBP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Pain

  The numerical visual scale evaluates levels of intensity of pain perceived by the patient through a range of 11 points (ranging from 0 to 10), 0 being no pain and 10 rank as the worst pain possible. Participants will be instructed to report the level of pain intensity based on the last 7 days.

  6 weeks

• Disability

  The Roland Morris disability questionnaire is an instrument widely used in research and clinical practice for evaluation of functional disability associated with back pain through 24 issues that describe everyday situations in which patients have difficulty to carry out due low back pain.

  6 weeks

Secondary Outcomes (3)

• Strength

  6 weeks

• Functioning (activities and participation)

  6 weeks

• Movement analysis with a 2-D system

  6 weeks

Other Outcomes (3)

• Pain

  6 months

• Disability

  6 months

• Functioning (activities and participation)

  6 months

Study Arms (2)

Conventional physical therapy plus HPCS

EXPERIMENTAL

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

Other: Conventional physical therapy plus HPCS

Conventional physical therapy

ACTIVE COMPARATOR

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

Other: Conventional physical therapy

Interventions

Conventional physical therapy plus HPCS OTHER

Conventional physical therapy plus the addition of hip posterolateral complex strengthening

Conventional physical therapy plus HPCS

Conventional physical therapy OTHER

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

Conventional physical therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Bahia: lead
• Fundação de Amparo à Pesquisa do Estado da Bahia: collaborator

Study Sites (1)

Mansueto Gomes Neto

Salvador, Estado de Bahia, 41950350, Brazil

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mansueto G Neto

  UFBA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mansueto Gomes-Neto, PhD

CONTACT

+557199188277; mansueto.neto@ufba.br

Mansueto Gomes-Neto

CONTACT

+557132838910; netofisio@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mansueto Gomes Neto

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 7, 2015
• Study Start: August 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2020
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

BR (1)