Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar Pain
Primary Purpose
Lumbar Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Segmental Stabilization Exercises
Home Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Pain
Eligibility Criteria
Inclusion Criteria:
- women aged between 18 and 65 years old
- chronic lumbar pain (at least 3 months)
- average pain intensity of ≥3 on a 10-point scale
Exclusion Criteria:
- presence of red flags (i.e.,tumor, known fractures, diagnosed inflammatory joint disease, etc);
- history of back surgery
- pregnancy
- less than 3 months of therapeutic treatment (physiotherapy) for low back pain
Sites / Locations
- Federal University of Health Sciences of Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Segmental Stabilization Group
Control Group
Arm Description
Patients receiving segmental stabilization exercises.
Patients receiving home exercises.
Outcomes
Primary Outcome Measures
Anticipatory Postural Adjustment by means of Electromyography
Assessed by means of superficial electromyography
Secondary Outcome Measures
Disability level via the Oswestry Low Back Pain Questionnaire
Fear of pain and avoidance of physical activity via the Fear-avoidance beliefs Questionnaire
Prognosis or risk of poor clinical outcome via the STarT Back Screening Tool
Pain level via visual analogue scale
Full Information
NCT ID
NCT02815358
First Posted
June 22, 2016
Last Updated
June 12, 2019
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02815358
Brief Title
Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
5. Study Description
Brief Summary
This study aims to verify the effects of a segmental stabilization exercise program on the anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be assessed by means of superficial electromyography focused on the registry of the onset of multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder flexion/extension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Segmental Stabilization Group
Arm Type
Experimental
Arm Description
Patients receiving segmental stabilization exercises.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients receiving home exercises.
Intervention Type
Other
Intervention Name(s)
Segmental Stabilization Exercises
Intervention Description
The stabilization program focuses on the reestablishment of motor control and coordination between deep and superficial trunk muscles. The exercise program is based on the following criteria progression: 1) Precise contraction of the transverse abdominal and multifidus muscles, keeping the lumbar spine in a neutral position (as the middle way between maximum flexion and extension, repeated three times); 2) Keep the neutral position for 10 repetitions of 10 seconds; 3) Perform exercises with lower limbs in different postures.
Intervention Type
Other
Intervention Name(s)
Home Exercises
Intervention Description
Home exercises include passive stretching and active mobilization of the spine.
Primary Outcome Measure Information:
Title
Anticipatory Postural Adjustment by means of Electromyography
Description
Assessed by means of superficial electromyography
Time Frame
change from pre to post-treatment (8 weeks)
Secondary Outcome Measure Information:
Title
Disability level via the Oswestry Low Back Pain Questionnaire
Time Frame
change from pre to post-treatment (8 weeks)
Title
Fear of pain and avoidance of physical activity via the Fear-avoidance beliefs Questionnaire
Time Frame
change from pre to post-treatment (8 weeks)
Title
Prognosis or risk of poor clinical outcome via the STarT Back Screening Tool
Time Frame
change from pre to post-treatment (8 weeks)
Title
Pain level via visual analogue scale
Time Frame
change from pre to post-treatment (8 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women aged between 18 and 65 years old
chronic lumbar pain (at least 3 months)
average pain intensity of ≥3 on a 10-point scale
Exclusion Criteria:
presence of red flags (i.e.,tumor, known fractures, diagnosed inflammatory joint disease, etc);
history of back surgery
pregnancy
less than 3 months of therapeutic treatment (physiotherapy) for low back pain
Facility Information:
Facility Name
Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar Pain
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