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Visual Feedback in Chronic Low Back Pain of Pregnant and Nonpregnant Women

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ClinicalTrials.gov Identifier: NCT03493360
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Anabela G Silva, Aveiro University

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Visual feedback Other: No visual feedback Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : June 28, 2018
Actual Study Completion Date : August 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Visual feedback
Participants will be asked to perform movements of the low back while looking at a mirror for visual feedback.
Other: Visual feedback
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.

Active Comparator: No visual feedback
Participants will be asked to perform movements of the low back while the mirrors are covered and no visual feedback is provided.
Other: No visual feedback
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 Measures :
  1. Pain intensity [ Time Frame: Baseline ]
    Measured using the visual analogue scale, which measures pain intensity (range: 0-10 and higher values are indicative of higher pain intensity)

  2. Pain intensity [ Time Frame: Immediately after the intervention (at 30 minutes) ]
    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 :
  1. Pain location [ Time Frame: Baseline ]
    Measured using a body chart

  2. Pain location [ Time Frame: Immediately after the intervention (at 30 minutes) ]
    Measured using a body chart

  3. Disability [ Time Frame: Baseline ]
    Assessed using the Roland Morris Questionnaire, which assesses low back pain associated disability (range: 0-24 and higher values indicate higher disability)

  4. Disability [ Time Frame: Immediately after the intervention (at 30 minutes) ]
    Assessed using the Roland Morris Questionnaire, which assesses low back pain associated disability (range: 0-24 and higher values indicate higher disability)

  5. Catastrophizing [ Time Frame: Baseline ]
    Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)

  6. Catastrophizing [ Time Frame: Immediately after the intervention (at 30 minutes) ]
    Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)

  7. Low back perception [ Time Frame: Baseline ]
    Assessed by asking participants to draw how they perceive their low back to be

  8. Low back perception [ Time Frame: Immediately after the intervention (at 30 minutes) ]
    Assessed by asking participants to draw how they perceive their low back to be

  9. Flexion range of motion [ Time Frame: Baseline ]
    The distance between the 3rd finger and the floor is measured with a ruler when participants lean forward.

  10. Flexion range of motion [ Time Frame: Immediately after the intervention (at 30 minutes) ]
    The distance between the 3rd finger and the floor is measured with a ruler when participants lean forward.

  11. Time taken to sit and stand 5 times [ Time Frame: Baseline ]
    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.

  12. Time taken to sit and stand 5 times [ Time Frame: Immediately after the intervention (at 30 minutes) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493360


Locations
Portugal
Escola Superior de Saúde
Aveiro, Portugal
Sponsors and Collaborators
Aveiro University
Investigators
Principal Investigator: Anabela Silva, PhD Aveiro University

Responsible Party: Anabela G Silva, Assistant Professor, Aveiro University
ClinicalTrials.gov Identifier: NCT03493360     History of Changes
Other Study ID Numbers: 14-CED/2018
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms