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

NCT ID: NCT03493360

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-10

Study Completion Date

2018-08-28

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Visual feedback

Participants will be asked to perform movements of the low back while looking at a mirror for visual feedback.

Group Type EXPERIMENTAL

Visual feedback

Intervention Type 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

Participants will be asked to perform movements of the low back while the mirrors are covered and no visual feedback is provided.

Group Type ACTIVE_COMPARATOR

No visual feedback

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aveiro University

OTHER

Sponsor Role lead

Responsible Party

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Anabela G Silva

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anabela Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Aveiro University

Locations

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Escola Superior de Saúde

Aveiro, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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14-CED/2018

Identifier Type: -

Identifier Source: org_study_id

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