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Completed

NCT Number: NCT03493360

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola Superior de Saúde

Aveiro, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Visual feedback

Other

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.

No visual feedback

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Registry information

Official study title

Feedback Visual na Lombalgia crónica da grávida e da não grávida/ Visual Feedback in Chronic Low Back Pain of Pregnant and Nonpregnant Women

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2018
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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