- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517606
Hip Posterolateral Complex Strengthening in Patients With Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Mansueto Gomes-Neto, PhD
- Phone Number: +557199188277
- Email: mansueto.neto@ufba.br
Study Contact Backup
- Name: Mansueto Gomes-Neto
- Phone Number: +557132838910
- Email: netofisio@gmail.com
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil, 41950350
- Recruiting
- Mansueto Gomes Neto
-
Contact:
- Mansueto G Neto, PhD
- Phone Number: 7132838910
- Email: fisioterapia.ics@hotmail.com
-
Contact:
- Mansueto G Neto, PhD
- Email: netofisio@gmail.com
-
Sub-Investigator:
- Thiago Y Fukuda, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
Conventional physical therapy plus the addition of hip posterolateral complex strengthening
|
Active Comparator: Conventional physical therapy
Conventional physical therapy (Combination of manual therapy techniques and exercises for spinal segmental stabilization)
|
Conventional physical therapy (combination of manual therapy techniques and exercises for spinal segmental stabilization)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 6 weeks
|
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
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength
Time Frame: 6 weeks
|
A previously calibrated manual hand-held dynamometer will be used to measure maximum isometric strength of abduction and hip extension
|
6 weeks
|
Functioning (activities and participation)
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Movement analysis with a 2-D system
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 6 months
|
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 months
|
Disability
Time Frame: 6 months
|
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 months
|
Functioning (activities and participation)
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mansueto G Neto, UFBA
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUBahia LBP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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