Clinical trial NCT03493360: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Aveiro University
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: Immediately after the intervention (at 30 minutes)
Secondary outcomes:
measure: Pain location
timeFrame: Baseline
measure: Pain location
timeFrame: Immediately after the intervention (at 30 minutes)
measure: Disability
timeFrame: Baseline
measure: Disability
timeFrame: Immediately after the intervention (at 30 minutes)
measure: Catastrophizing
timeFrame: Baseline
measure: Catastrophizing
timeFrame: Immediately after the intervention (at 30 minutes)
measure: Low back perception
timeFrame: Baseline
measure: Low back perception
timeFrame: Immediately after the intervention (at 30 minutes)
measure: Flexion range of motion
timeFrame: Baseline
measure: Flexion range of motion
timeFrame: Immediately after the intervention (at 30 minutes)
measure: Time taken to sit and stand 5 times
timeFrame: Baseline
measure: Time taken to sit and stand 5 times
timeFrame: Immediately after the intervention (at 30 minutes)
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: Escola Superior de Saúde
Study officials:
affiliation: Aveiro University
name: Anabela Silva, PhD
role: PRINCIPAL_INVESTIGATOR
References: