Chronic Low Back PainNCT03635242
Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Healed Patients
A study testing Experimental. Therapeutic program in people with Chronic Low Back Pain and Postural Low Back Pain, run by University of Extremadura at 1 site in Spain.
Trial summary
Pretending with the use of accelerometers and pressure platform, determine indicators that are useful to therapists to assess postural control and balance, to subsequently allow to evaluate the effect of therapeutic interventions through therapeutic exercise of motor control in patients with chronic low back pain . Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain, Postural Low Back Pain
- What is being tested?
- Experimental. Therapeutic program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jun 2018to 9 Oct 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- low back pain with painful perception on a daily or almost daily basis for more than three months of clinical course, with or without pain radiating to the lower extremities above the knee.
- not having metal implants in the spine
- own ability to read and write
- and access the study voluntarily.
Who cannot join
- vestibular disorders
- without severe visual impairment
- no medication intake with a potential effect on balance during the 90 days prior to data collection
- physiotherapy treatment 2 weeks before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Post-treatment Healed Patients by Therapeutic Exercise
Pretending with the use of accelerometers and pressure platform, determine indicators that are useful to therapists to assess postural control and balance, to subsequently allow to evaluate the effect of therapeutic interventions through therapeutic exercise of motor control in patients with chronic low back pain .
Read the detailed description
The records are made simultaneously with the different evaluation equipment, accelerometer and pressure platform. The tests are performed in a control group of healthy subjects, and in an experimental group with DLC receiving a program of therapeutic exercise based and pain education based on neuroscience.
After the collection of the records, the behavior patterns in both groups are evaluated, the possible differences among them are established for the clinimetric indicators analyzed related to the postural control, as well as a characteristic of the sample.
Subsequently, through the evaluation after the intervention of the experimental group we will analyze the effect of a physiotherapy treatment based on the therapeutic exercise of motor control on parameters related to postural control and clinical variables (perceived pain, mechanosensitivity, disability and proprioceptive repositioning of the lumbar spine )
- Conditions
- Chronic Low Back Pain, Postural Low Back Pain
- Being tested
- Control. no therapeutic program, Experimental. Therapeutic program
- Keywords
- postural control, Chronic Low Back Pain, therapeutic excercise, healed patients
- 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.
Control. no therapeutic programOther
The control group continued to perform their daily activities without changing any habit. Group of healthy subjects Assessment of postural control through accelerometry and pressure platform
Experimental. Therapeutic programOther
People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months.
Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform
| Study group | Role | What they receive |
|---|---|---|
| Control. no therapeutic program | Active comparator | The control group continued to perform their daily activities without changing any habit. Group of healthy subjects Assessment of postural control through accelerometry and pressure platform Receives: Other: Control. no therapeutic program |
| Experimental. Therapeutic program | Experimental | People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months.
Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform Receives: Other: Experimental. Therapeutic program |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure platform and accelerometry
Stay for 30 seconds each test on a pressure platform. Accelerometer in the pelvis (center of mass), fixed by velcro tape. Application of the Romberg test. (Standing with open eyes and closed on stable and unstable surface).The unit of the accelerometer is mg (1 mg = 0.001) and the kinetic energy of the signal is measured in Julians x 10-6 The displacement unit of the pressure center of the platform is millimeters
Measured: 4 weeks
Secondary outcomes (10)
weight
Descriptive variable. Its unit of measurement is Kilograms
Measured: 4 weeks
Height
Descriptive variable. Its unit of measurement is meters
Measured: 4 weeks
age
Descriptive variable. Its unit of measurement is years
Measured: 4 weeks
EVA (Visual Analog Scale).
Used for pain assessment in an analogical way, that is, by means of a line of 10 centimeters. 0 (absence of pain); 10 (maximum pain)
Measured: 4 weeks
Algometry
Algometry at 5 cm from the spinous process of L3 and in lateral epicondyl (Bilateral)
Measured: 4 weeks
Joint Position Sense (JPS)
Joint Position Sense (JPS) to evaluate the proprioceptive joint positioning of the lumbar spine with a digital goniometer at 30º flexion in standing and sitting
Measured: 4 weeks
Roland Morris
determine the degree of disability. The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)
Measured: 4 weeks
Oswestry Disability Index
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability
Scoring instructions For each section of the total possible score is 5: if the first statement is mark ed the section score = 0; if the last statement is marked, it = 5.
Measured: 4 weeks
Pain Catastrophizing Scale (PCS)
it measures the catastrophic thoughts before the pain, that is, the negative thought before the pain. In the PCS, people take the painful past experience as a reference and indicate the degree to which they experience certain thoughts and feelings. The PCS is composed of 13 items, on a Likert scale of 5 points that goes from 0 (never) to 4 (always).
Higher scores indicate higher levels of catastrophism
Measured: 4 weeks
The Tampa Kinesiofobia Scale (TSK)
It is commonly used in clinical practice to quantify pain levels related to fear of activity or to a new injury in patients with back pain. Patients with high levels of kinesiofobia are often considered at greater risk of developing long-term activity limitation and chronicity
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start8 Jun 2018
- Primary completion8 Aug 2018
- Study completion9 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Caña Pino, University of Extremadura
- Investigators
- Luis LE Espejo-Antúnez, PhD, Study director, Universidad de Extremadura. Facultad de Medicina (Badajoz). SpainMª Dolores MD Apolo-Arenas, PhD, Study director, Universidad de Extremadura. Facultad de Medicina (Badajoz). SpainAlejandro Caña-Pino, PT,MSc, Principal investigator, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635242
- Sponsor's protocol ID
- 08062018
- Status last verified
- Mar 2020
- First submitted
- 10 Aug 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Post-treatment Healed Patients by Therapeutic Exercise
- ClinicalTrials.gov ID
- NCT03635242
- Acronym / sponsor ID
- 08062018
- Conditions
- Chronic Low Back Pain, Postural Low Back Pain
- Keywords
- postural control, Chronic Low Back Pain, therapeutic excercise, healed patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 17 Aug 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.
Pretending with the use of accelerometers and pressure platform, determine indicators that are useful to therapists to assess postural control and balance, to subsequently allow to evaluate the effect of therapeutic interventions through therapeutic exercise of motor control in patients with chronic low back pain .
Detailed description
The records are made simultaneously with the different evaluation equipment, accelerometer and pressure platform. The tests are performed in a control group of healthy subjects, and in an experimental group with DLC receiving a program of therapeutic exercise based and pain education based on neuroscience.
After the collection of the records, the behavior patterns in both groups are evaluated, the possible differences among them are established for the clinimetric indicators analyzed related to the postural control, as well as a characteristic of the sample.
Subsequently, through the evaluation after the intervention of the experimental group we will analyze the effect of a physiotherapy treatment based on the therapeutic exercise of motor control on parameters related to postural control and clinical variables (perceived pain, mechanosensitivity, disability and proprioceptive repositioning of the lumbar spine )
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control. no therapeutic program | Active comparator | Other: Control. no therapeutic programThe control group continued to perform their daily activities without changing any habit. Group of healthy subjects Assessment of postural control through accelerometry and pressure platform |
| Experimental. Therapeutic program | Experimental | Other: Experimental. Therapeutic programPeople with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months. Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- low back pain with painful perception on a daily or almost daily basis for more than three months of clinical course, with or without pain radiating to the lower extremities above the knee.
- not having metal implants in the spine
- own ability to read and write
- and access the study voluntarily.
Key exclusion criteria (4 listed)
- vestibular disorders
- without severe visual impairment
- no medication intake with a potential effect on balance during the 90 days prior to data collection
- physiotherapy treatment 2 weeks before the study
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 |
|---|---|---|
| Control. no therapeutic programThe control group continued to perform their daily activities without changing any habit. Group of healthy subjects Assessment of postural control through accelerometry and pressure platform | Other | Control. no therapeutic program |
| Experimental. Therapeutic programPeople with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months. Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform | Other | Experimental. Therapeutic program |
Primary outcome
pressure platform and accelerometry
Time frame: 4 weeks
Stay for 30 seconds each test on a pressure platform. Accelerometer in the pelvis (center of mass), fixed by velcro tape. Application of the Romberg test. (Standing with open eyes and closed on stable and unstable surface).The unit of the accelerometer is mg (1 mg = 0.001) and the kinetic energy of the signal is measured in Julians x 10-6 The displacement unit of the pressure center of the platform is millimeters
10 secondary outcomes
weight
Time frame: 4 weeks
Height
Time frame: 4 weeks
age
Time frame: 4 weeks
EVA (Visual Analog Scale).
Time frame: 4 weeks
Algometry
Time frame: 4 weeks
Joint Position Sense (JPS)
Time frame: 4 weeks
Roland Morris
Time frame: 4 weeks
Oswestry Disability Index
Time frame: 4 weeks
Pain Catastrophizing Scale (PCS)
Time frame: 4 weeks
The Tampa Kinesiofobia Scale (TSK)
Time frame: 4 weeks
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 17 Mar 2020.
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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.
Luis LE Espejo-Antúnez, PhD study director
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Mª Dolores MD Apolo-Arenas, PhD study director
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Alejandro Caña-Pino, PT,MSc principal investigator
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental. Therapeutic program in people with Chronic Low Back Pain and Postural Low Back Pain, run by University of Extremadura at 1 site in Spain.
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 4 inclusion and 4 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 17 Mar 2020. 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 Spain. 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?
pressure platform and accelerometry (time frame: 4 weeks). 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 17 Mar 2020.