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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493360
• Other study ID #: 14-CED/2018
• Status: Completed
• Phase: N/A
• Start date: April 10, 2018
• Est. completion date: August 28, 2018

Study information

• Verified date: September 2018
• Source: Aveiro University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Portugal	Escola Superior de Saúde	Aveiro

Sponsors (1)

Lead Sponsor	Collaborator
Aveiro University

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Measured using the visual analogue scale, which measures pain intensity (range: 0-10 and higher values are indicative of higher pain intensity)	Baseline
Primary	Pain intensity	Measured using the visual analogue scale, which measures pain intensity (range: 0-10 and higher values are indicative of higher pain intensity)	Immediately after the intervention (at 30 minutes)
Secondary	Pain location	Measured using a body chart	Baseline
Secondary	Pain location	Measured using a body chart	Immediately after the intervention (at 30 minutes)
Secondary	Disability	Assessed using the Roland Morris Questionnaire, which assesses low back pain associated disability (range: 0-24 and higher values indicate higher disability)	Baseline
Secondary	Disability	Assessed using the Roland Morris Questionnaire, which assesses low back pain associated disability (range: 0-24 and higher values indicate higher disability)	Immediately after the intervention (at 30 minutes)
Secondary	Catastrophizing	Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)	Baseline
Secondary	Catastrophizing	Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)	Immediately after the intervention (at 30 minutes)
Secondary	Low back perception	Assessed by asking participants to draw how they perceive their low back to be	Baseline
Secondary	Low back perception	Assessed by asking participants to draw how they perceive their low back to be	Immediately after the intervention (at 30 minutes)
Secondary	Flexion range of motion	The distance between the 3rd finger and the floor is measured with a ruler when participants lean forward.	Baseline
Secondary	Flexion range of motion	The distance between the 3rd finger and the floor is measured with a ruler when participants lean forward.	Immediately after the intervention (at 30 minutes)
Secondary	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.	Baseline
Secondary	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.	Immediately after the intervention (at 30 minutes)