- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02815358
Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar Pain
June 12, 2019 updated by: Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil
- Federal University of Health Sciences of Porto Alegre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Segmental Stabilization Group
Patients receiving segmental stabilization exercises.
|
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.
|
|
Active Comparator: Control Group
Patients receiving home exercises.
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Home exercises include passive stretching and active mobilization of the spine.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anticipatory Postural Adjustment by means of Electromyography
Time Frame: change from pre to post-treatment (8 weeks)
|
Assessed by means of superficial electromyography
|
change from pre to post-treatment (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Disability level via the Oswestry Low Back Pain Questionnaire
Time Frame: change from pre to post-treatment (8 weeks)
|
change from pre to post-treatment (8 weeks)
|
|
Fear of pain and avoidance of physical activity via the Fear-avoidance beliefs Questionnaire
Time Frame: change from pre to post-treatment (8 weeks)
|
change from pre to post-treatment (8 weeks)
|
|
Prognosis or risk of poor clinical outcome via the STarT Back Screening Tool
Time Frame: change from pre to post-treatment (8 weeks)
|
change from pre to post-treatment (8 weeks)
|
|
Pain level via visual analogue scale
Time Frame: change from pre to post-treatment (8 weeks)
|
change from pre to post-treatment (8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
June 22, 2016
First Submitted That Met QC Criteria
June 23, 2016
First Posted (Estimate)
June 28, 2016
Study Record Updates
Last Update Posted (Actual)
June 13, 2019
Last Update Submitted That Met QC Criteria
June 12, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 923.642
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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