Low Back PainNCT03493360
Visual Feedback in Chronic Low Back Pain of Pregnant and Nonpregnant Women
A study testing Visual feedback and No visual feedback in people with Low Back Pain, run by Aveiro University at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Visual feedback and No visual feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Apr 2018to 28 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Visual feedback, No visual feedback
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual feedbackOther
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 feedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Visual feedback | Experimental | Participants will be asked to perform movements of the low back while looking at a mirror for visual feedback. Receives: 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. Receives: Other: No visual feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured using the visual analogue scale, which measures pain intensity (range: 0-10 and higher values are indicative of higher pain intensity)
Measured: 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)
Measured: Immediately after the intervention (at 30 minutes)
Secondary outcomes (12)
Pain location
Measured using a body chart
Measured: Baseline
Pain location
Measured using a body chart
Measured: Immediately after the intervention (at 30 minutes)
Disability
Assessed using the Roland Morris Questionnaire, which assesses low back pain associated disability (range: 0-24 and higher values indicate higher disability)
Measured: Baseline
Disability
Assessed using the Roland Morris Questionnaire, which assesses low back pain associated disability (range: 0-24 and higher values indicate higher disability)
Measured: Immediately after the intervention (at 30 minutes)
Catastrophizing
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Measured: Baseline
Catastrophizing
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Measured: Immediately after the intervention (at 30 minutes)
Low back perception
Assessed by asking participants to draw how they perceive their low back to be
Measured: Baseline
Low back perception
Assessed by asking participants to draw how they perceive their low back to be
Measured: Immediately after the intervention (at 30 minutes)
Flexion range of motion
The distance between the 3rd finger and the floor is measured with a ruler when participants lean forward.
Measured: Baseline
Flexion range of motion
The distance between the 3rd finger and the floor is measured with a ruler when participants lean forward.
Measured: Immediately after the intervention (at 30 minutes)
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.
Measured: Baseline
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.
Measured: Immediately after the intervention (at 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start10 Apr 2018
- Primary completion28 Jun 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
- Investigators
- Anabela Silva, PhD, Principal investigator, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493360
- Sponsor's protocol ID
- 14-CED/2018
- Status last verified
- Sep 2018
- First submitted
- 4 Apr 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03493360
- Acronym / sponsor ID
- 14-CED/2018
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual feedback | Experimental | Other: Visual feedbackParticipants will be asked to perform movements of the low back while looking at a mirror for visual feedback. |
| No visual feedback | Active comparator | Other: No visual feedbackParticipants will be asked to perform movements of the low back while the mirrors are covered and no visual feedback is provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual feedbackParticipants 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. | Other | Visual feedback |
| No visual feedbackParticipants 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. | Other | No visual feedback |
Primary outcome
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)
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)
12 secondary outcomes
Pain location
Time frame: Baseline
Pain location
Time frame: Immediately after the intervention (at 30 minutes)
Disability
Time frame: Baseline
Disability
Time frame: Immediately after the intervention (at 30 minutes)
Catastrophizing
Time frame: Baseline
Catastrophizing
Time frame: Immediately after the intervention (at 30 minutes)
Low back perception
Time frame: Baseline
Low back perception
Time frame: Immediately after the intervention (at 30 minutes)
Flexion range of motion
Time frame: Baseline
Flexion range of motion
Time frame: Immediately after the intervention (at 30 minutes)
Time taken to sit and stand 5 times
Time frame: Baseline
Time taken to sit and stand 5 times
Time frame: Immediately after the intervention (at 30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anabela Silva, PhD principal investigator
Aveiro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual feedback and No visual feedback in people with Low Back Pain, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.