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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
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
June 22, 2016
Last Updated
June 12, 2019
Sponsor
Federal University of Health Science of Porto Alegre
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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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