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

NCT03493360 | Completed

• 1 other identifier: 14-CED/2018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• Pain location

  Baseline

• Pain location

  Immediately after the intervention (at 30 minutes)

• Disability

  Baseline

• Disability

  Immediately after the intervention (at 30 minutes)

• Catastrophizing

  Baseline

Study Arms (2)

Visual feedback

EXPERIMENTAL

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

Other: Visual feedback

No visual feedback

ACTIVE COMPARATOR

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

Interventions

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.

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.

No visual feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aveiro University: lead

Study Sites (1)

Escola Superior de Saúde

Aveiro, Portugal

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Feedback, Sensory

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Feedback, Physiological; Homeostasis; Physiological Phenomena

Study Officials

• Anabela Silva, PhD

  Aveiro University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 10, 2018
• Study Start: April 10, 2018
• Primary Completion: June 28, 2018
• Study Completion: August 28, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)