Visual Feedback in Chronic Low Back Pain of Pregnant and Nonpregnant Women
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Visual feedback
No visual feedback
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- The sample will consist of 15 pregnant participants (ideally between the 2nd and 3rd trimester of gestation) with chronic idiopathic low back pain and a group of 15 non-pregnant women with chronic idiopathic low back pain.
Exclusion Criteria:
- Pregnant women with risk pregnancy will be excluded as well as low back pain with a known cause (e.g. radiculopathy) and all participants with serious pathologies (e.g. history of trauma, surgery for less than 12 months, neurological pathologies, tumors).
Sites / Locations
- Escola Superior de Saúde
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Visual feedback
No visual feedback
Arm Description
Participants will be asked to perform movements of the low back while looking at a mirror for visual feedback.
Participants will be asked to perform movements of the low back while the mirrors are covered and no visual feedback is provided.
Outcomes
Primary Outcome Measures
Pain intensity
Measured using the visual analogue scale, which measures pain intensity (range: 0-10 and higher values are indicative of higher pain intensity)
Pain intensity
Measured using the visual analogue scale, which measures pain intensity (range: 0-10 and higher values are indicative of higher pain intensity)
Secondary Outcome Measures
Pain location
Measured using a body chart
Pain location
Measured using a body chart
Disability
Assessed using the Roland Morris Questionnaire, which assesses low back pain associated disability (range: 0-24 and higher values indicate higher disability)
Disability
Assessed using the Roland Morris Questionnaire, which assesses low back pain associated disability (range: 0-24 and higher values indicate higher disability)
Catastrophizing
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Catastrophizing
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Low back perception
Assessed by asking participants to draw how they perceive their low back to be
Low back perception
Assessed by asking participants to draw how they perceive their low back to be
Flexion range of motion
The distance between the 3rd finger and the floor is measured with a ruler when participants lean forward.
Flexion range of motion
The distance between the 3rd finger and the floor is measured with a ruler when participants lean forward.
Time taken to sit and stand 5 times
Measured using the sit-to-stand test, i.e., the time, in seconds, that a participant takes to sit and stand from a common chair 5 consecutive times.
Time taken to sit and stand 5 times
Measured using the sit-to-stand test, i.e., the time, in seconds, that a participant takes to sit and stand from a common chair 5 consecutive times.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03493360
Brief Title
Visual Feedback in Chronic Low Back Pain of Pregnant and Nonpregnant Women
Official Title
Feedback Visual na Lombalgia crónica da grávida e da não grávida/ Visual Feedback in Chronic Low Back Pain of Pregnant and Nonpregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this study are to:
Evaluate the effect of visual feedback on the intensity of low back pain, range of motion and function of pregnant and non-pregnant women with chronic low back pain.
Determine the association between low back pain, catastrophizing, fear of movement and low back perception/image.
Detailed Description
It is antecipated that 15 pregnant women with low back pain and 15 non-pregnant women with low back pain will enter the study. Each group will receive two different interventions, one consisting of visual feedback when performing 10 repetitions of low back flexion, extension and right and left side-flexion and another intervention consisting of the same low back movements without visual feedback. Participants will be assessed for pain intensity, pain location, disability, kinesiophobia, catastrophizing, perception of the low back, flexion range of motion and time to perform the sit to stand test both at baseline and after the intervention.
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
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visual feedback
Arm Type
Experimental
Arm Description
Participants will be asked to perform movements of the low back while looking at a mirror for visual feedback.
Arm Title
No visual feedback
Arm Type
Active Comparator
Arm Description
Participants will be asked to perform movements of the low back while the mirrors are covered and no visual feedback is provided.
Intervention Type
Other
Intervention Name(s)
Visual feedback
Intervention Description
Participants will be asked to perform 10 repetitions of low back flexion, extension and lateral side-flexions while looking at their back in a mirror for visual feedback.
Intervention Type
Other
Intervention Name(s)
No visual feedback
Intervention Description
Participants will be asked to perform 10 repetitions of low back flexion, extension and lateral side-flexions while looking at a mirror that is covered and no visual feedback is provided.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Measured using the visual analogue scale, which measures pain intensity (range: 0-10 and higher values are indicative of higher pain intensity)
Time Frame
Baseline
Title
Pain intensity
Description
Measured using the visual analogue scale, which measures pain intensity (range: 0-10 and higher values are indicative of higher pain intensity)
Time Frame
Immediately after the intervention (at 30 minutes)
Secondary Outcome Measure Information:
Title
Pain location
Description
Measured using a body chart
Time Frame
Baseline
Title
Pain location
Description
Measured using a body chart
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Disability
Description
Assessed using the Roland Morris Questionnaire, which assesses low back pain associated disability (range: 0-24 and higher values indicate higher disability)
Time Frame
Baseline
Title
Disability
Description
Assessed using the Roland Morris Questionnaire, which assesses low back pain associated disability (range: 0-24 and higher values indicate higher disability)
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Catastrophizing
Description
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Time Frame
Baseline
Title
Catastrophizing
Description
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Low back perception
Description
Assessed by asking participants to draw how they perceive their low back to be
Time Frame
Baseline
Title
Low back perception
Description
Assessed by asking participants to draw how they perceive their low back to be
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Flexion range of motion
Description
The distance between the 3rd finger and the floor is measured with a ruler when participants lean forward.
Time Frame
Baseline
Title
Flexion range of motion
Description
The distance between the 3rd finger and the floor is measured with a ruler when participants lean forward.
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Time taken to sit and stand 5 times
Description
Measured using the sit-to-stand test, i.e., the time, in seconds, that a participant takes to sit and stand from a common chair 5 consecutive times.
Time Frame
Baseline
Title
Time taken to sit and stand 5 times
Description
Measured using the sit-to-stand test, i.e., the time, in seconds, that a participant takes to sit and stand from a common chair 5 consecutive times.
Time Frame
Immediately after the intervention (at 30 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The sample will consist of 15 pregnant participants (ideally between the 2nd and 3rd trimester of gestation) with chronic idiopathic low back pain and a group of 15 non-pregnant women with chronic idiopathic low back pain.
Exclusion Criteria:
Pregnant women with risk pregnancy will be excluded as well as low back pain with a known cause (e.g. radiculopathy) and all participants with serious pathologies (e.g. history of trauma, surgery for less than 12 months, neurological pathologies, tumors).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anabela Silva, PhD
Organizational Affiliation
Aveiro University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola Superior de Saúde
City
Aveiro
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Visual Feedback in Chronic Low Back Pain of Pregnant and Nonpregnant Women
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