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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Conventional physical therapy plus HPCS
Conventional physical therapy
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansueto Gomes NetoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conventional physical therapy plus HPCS

Conventional physical therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Strength
A previously calibrated manual hand-held dynamometer will be used to measure maximum isometric strength of abduction and hip extension
Functioning (activities and participation)
The World Health Organization Disabilty Assessment Schedule (WHODAS 2.0) 2.0 is a tool developed by the World Health Organization (who) to assess the limitations in activities and participation restrictions already adapted and validated in Brazil. The WHODAS 2.0 was designed to evaluate the functionality in 6 areas of activity: cognition, mobility, self-care, interpersonal relationships, daily activities and Participation.
Movement analysis with a 2-D system
The gait and step down kinematic parameters will be calculated with SIMI Reality Motion Systems. The subjects will be fitted with colors markers on the lower limbs and trunk. Our approach automatically processes video sequences gathered with a digital camera and extract the 2D joints' location and their angle trend over time. The peaks of the movements of the hip, pelvis and trunk in the frontal and sagittal planes will be evaluated and compared between groups before and after treatment.

Full Information

First Posted
August 5, 2015
Last Updated
November 5, 2018
Sponsor
Federal University of Bahia
Collaborators
Fundação de Amparo à Pesquisa do Estado da Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT02517606
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia
Collaborators
Fundação de Amparo à Pesquisa do Estado da Bahia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional physical therapy plus HPCS
Arm Type
Experimental
Arm Description
Conventional physical therapy (Combination of manual therapy techniques and exercises for spinal segmental stabilization) plus the addition of hip posterolateral complex strengthening (HPCS)
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Conventional physical therapy (Combination of manual therapy techniques and exercises for spinal segmental stabilization)
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy plus HPCS
Intervention Description
Conventional physical therapy plus the addition of hip posterolateral complex strengthening
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
Conventional physical therapy (combination of manual therapy techniques and exercises for spinal segmental stabilization)
Primary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
6 weeks
Title
Disability
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Strength
Description
A previously calibrated manual hand-held dynamometer will be used to measure maximum isometric strength of abduction and hip extension
Time Frame
6 weeks
Title
Functioning (activities and participation)
Description
The World Health Organization Disabilty Assessment Schedule (WHODAS 2.0) 2.0 is a tool developed by the World Health Organization (who) to assess the limitations in activities and participation restrictions already adapted and validated in Brazil. The WHODAS 2.0 was designed to evaluate the functionality in 6 areas of activity: cognition, mobility, self-care, interpersonal relationships, daily activities and Participation.
Time Frame
6 weeks
Title
Movement analysis with a 2-D system
Description
The gait and step down kinematic parameters will be calculated with SIMI Reality Motion Systems. The subjects will be fitted with colors markers on the lower limbs and trunk. Our approach automatically processes video sequences gathered with a digital camera and extract the 2D joints' location and their angle trend over time. The peaks of the movements of the hip, pelvis and trunk in the frontal and sagittal planes will be evaluated and compared between groups before and after treatment.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Pain
Description
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.
Time Frame
6 months
Title
Disability
Description
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.
Time Frame
6 months
Title
Functioning (activities and participation)
Description
The World Health Organization Disabilty Assessment Schedule (WHODAS 2.0) 2.0 is a tool developed by the World Health Organization (who) to assess the limitations in activities and participation restrictions already adapted and validated in Brazil. The WHODAS 2.0 was designed to evaluate the functionality in 6 areas of activity: cognition, mobility, self-care, interpersonal relationships, daily activities and Participation.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mansueto Gomes-Neto, PhD
Phone
+557199188277
Email
mansueto.neto@ufba.br
First Name & Middle Initial & Last Name or Official Title & Degree
Mansueto Gomes-Neto
Phone
+557132838910
Email
netofisio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansueto G Neto
Organizational Affiliation
UFBA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansueto Gomes Neto
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950350
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mansueto G Neto, PhD
Phone
7132838910
Email
fisioterapia.ics@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mansueto G Neto, PhD
Email
netofisio@gmail.com
First Name & Middle Initial & Last Name & Degree
Thiago Y Fukuda, PhD

12. IPD Sharing Statement

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

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