Low Back PainNCT03880370
RELATIONSHIP OF LUMBOPELVIC MUSCULATURE WITH FUNCTIONAL TESTS IN NON-PROFESSIONAL ATHLETES WITH LUMBAR DISC HERNIATION
An observational study of Low Back Pain and Herniated Lumbar Disk, run by Universidad Complutense de Madrid.
Trial summary
This is a control-case study. It has been designed to determine if there is a relationship between the cross sectional (thickness), through RUSI ultrasound, of the abdominal muscles, lumbar and hip muscles with the results of the functional tests, to determine its relevance in patients with low back pain and / or… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Low Back Pain, Herniated Lumbar Disk, Sciatica
- What is being tested?
- Questionnaires / scales, Ultrasound imaging and FLEXIBILITY
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 31 Dec 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 55 years
- All sexes
- Adult
Study population: Men and women between 18 and 55 years old. Non-professional sports practice equal to greater than 3 hours per week
Who may be able to join
- Age 18 to 55 years of age.
- Sports practice equal to greater than three hours per week.
- No low back pain or ciatalgia in the last 12 months.
Who cannot join
- Traumatic process or surgery in the lower back or lower limb in the last year.
- Alterations of the skin or local infection in the area to be examined or that impedes the ultrasonographic measurement or performance of the functional tests.
- Peripheral or central neurological pathology.
- Psychiatric pathology and / or cognitive alterations.
- Inflammatory and tumor diseases.
- Alterations that prevent the understanding of the indications and / or the performance of the tests.
Show all 9Show fewer
- Group selection criteria:
- Group 1(group without low back pain): No low back pain or ciatalgia in the last 12 months.
- Group 2 (low back pain group): History of at least one episode of low back pain and / or ciatalgia in the last 12 months lasting no longer than three months and diagnosis of hernia lumbar disc using MRI.
Trial locations and contacts
No sites are listed yet.
About this study
This is a control-case study. It has been designed to determine if there is a relationship between the cross sectional (thickness), through RUSI ultrasound, of the abdominal muscles, lumbar and hip muscles with the results of the functional tests, to determine its relevance in patients with low back pain and / or ciatalgia and lumbar disc herniation in non-professional athletes. The secondary objectives of the study will be to know if there is a relationship between the results of ultrasound measurements and functional tests with the result of the disability questionnaires, the amount of pain and its location, as well as determine the relevance, depending on the results of ultrasound measurements and test of the presence or not of a lumbar disc herniation.
- Conditions
- Low Back Pain, Herniated Lumbar Disk, Sciatica
- Being tested
- Questionnaires / scales, Ultrasound imaging, FLEXIBILITY, FUNCTIONAL TESTS
- Keywords
- ultrasound, functional test, herniated lumbar disk, low back pain
- Medical subject headings
- Low Back Pain, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires / scalesBehavioural
EVA, ROLAND MORRIS, OWESTRY and Global Questionnaire of Physical Activity (GPAQ)
Ultrasound imagingDiagnostic test
Rectus abdominis dominant side \& non-dominant side external oblique dominant side \& non-dominant side internal oblique dominant side \& non-dominant side transversus abdominis dominant side \& non-dominant side lumbar multififidus l4-l5-s1 gluteus medius dominant side \& non-dominant side
FLEXIBILITYDiagnostic test
weight-bearing lunge hip lateral rotation straight leg raise fingertip to floor test
FUNCTIONAL TESTSDiagnostic test
Star excursion balance test (sebt) prone bridging test Side bridging test Modified biering-sørensen
| Study group | Role | What they receive |
|---|---|---|
| group 1(group without low back pain) | Participants inclusion criteria an age 18 to 55 years of age who practice sports equal to greater than three hours per week who have not had low back pain or ciatalgia in the last 12 months. Receives: Behavioral: Questionnaires / scales; Diagnostic Test: Ultrasound imaging; Diagnostic Test: FLEXIBILITY; Diagnostic Test: FUNCTIONAL TESTS | |
| group 2 (low back pain group) | Participants inclusion criteria an age 18 and 55 years of age who practice sports equal to greater than three hours a week, with a history of at least one episode of low back pain and / or ciatalgia in the last 12 months lasting no longer than three months and diagnosis of hernia lumbar disc using MRI. Receives: Behavioral: Questionnaires / scales; Diagnostic Test: Ultrasound imaging; Diagnostic Test: FLEXIBILITY; Diagnostic Test: FUNCTIONAL TESTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound changes in muscle cross-sectional area produced of the transversus abdominis.
Ultrasound changes in muscle cross-sectional area produced of the transversus abdominis.
Measured: 5 minutes
Ultrasound changes in muscle cross-sectional area (CSA) produced of the internal oblique.
Ultrasound changes in muscle cross-sectional area (CSA) produced of the internal oblique.
Measured: 5 minutes
Ultrasound changes in muscle cross-sectional area (CSA)produced of the external oblique.
Ultrasound changes in muscle cross-sectional area (CSA) produced of the external oblique.
Measured: 5 minutes
Ultrasound changes in muscle cross-sectional area (CSA)produced of the rectus abdominis.
Ultrasound changes in muscle cross-sectional area (CSA)produced of the rectus abdominis.
Measured: 5 minutes
Ultrasound changes in muscle cross-sectional area (CSA)produced of the lumbar multifidus.
Ultrasound changes in muscle cross-sectional area (CSA)produced of the lumbar multifidus.
Measured: 5 minutes
Secondary outcomes (9)
Ultrasound changes in muscle cross-sectional area (CSA) produced of the gluteus medius.
Ultrasound changes in muscle cross-sectional area (CSA) produced of the gluteus medius.
Measured: 10 minutes
Functional test. Star excursion balance test (SEBT)
Test Position: Standing barefoot on a grid with an anterior, posteromedial and posterolateral line at a 45° angle away from the projected anterior line.
For the anterior test: most distal aspect of the toes aligned with the tape, centre of heel in line with the tape. For the posterior tests: most posterior aspect of the heel aligned with the tape and the second toe on the tape.
Test: Stand barefoot with the foot aligned to the tape and hands to the side. With the other leg, reach out as far as possible in the tested direction with the most distal part of the foot. 4 practice trials are mandatory in each direction, test each direction 3 times.
Measurement: Measure the reach distance in each direction and register the maximal reach distance in cm. The distances will be compared to each other and to the respective functional leg length. The best result is the longest distance
Measured: 10 minutes
Functional test. Side bridging test
Test Position:
Athlete is side-lying on an exercise mat. Both feet are in contact with the floor, the fore-arm perpendicular to the athlete's body. The other hand is holding the shoulder.
Test:
Athlete attains a side-bridge position, keeping both feet and one fore-arm in contact with the floor. Tester helps the athlete attain a neutral position of the lumbar spine and positions the head in the same line.
Two practice trials are allowed. Test both sides, with at least 10 minutes of rest between sides.
In some cases, only 1 side needs to be tested.
Measurement:
Measure the time the athlete is able to keep this neutral position. Correct the athlete's position if necessary, if he's unable to maintain the position for 2 consecutive seconds, stop the test. The best result is the longest time
Measured: 10 minutes
Functional test. Modified biering-sørensen
Test Position:
Prone position, the ASIS just over the edge of the treatment table. Arms crossed over shoulders.Neutral position of spine.
Test:
Instruct the athlete to maintain the neutral position as long as possible (surfaced at 4min).Test fails when the athlete is unable to maintain this position for more than 2 executive seconds (2 corrections allowed). Fail towards hyperextension/flexion. A horizontal cord at spina scapula level can be used to identify deficits.
Measurement:
Timing is recorded and marked in seconds. The best result is the longest time
Measured: 10 minutes
Functional test. Prone bridging test
Test Position:
Prone-lying with parallel forearms, thumbs up and straight legs.
Test:
Attain a bridging position with vertical upper arms and with the shoulder, greater trochanter and lateral malleolus in line. The head keeps in contact with an wall in front of a pacient to avoid excessive head movement. Two practice trials are allowed.
Measurement:
Measure the time the athlete is able to keep this frequency and the correct position. Correct the athlete's position if necessary, if he's unable to maintain the position or the frequency, stop the test. The best result is the longest time
Measured: 10 minutes
VAS escale
The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best).
Scoring and Interpretation: Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 1 minute
Roland-Morris Disability Questionnaire
It is used to 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: 5 minutes
The Owestry Disability Index
Interpretation:
Add the points of each section and place them in the following formula, in order to calculate your level of disability. total points / 50 X 100 =% disability (also known as: 'total points' divided by' 50 ', multiplied by' 100 = percentage of disability)
ODI score:
0% to 20% (minimum disability) 21% to 40% (moderate disability) 41% to 60% (severe disability) 61% to 80% (paralyzed) 81% -100%: These patients may be bedridden or may be exaggerating symptoms. A careful evaluation is recommended.
Measured: 5 minutes
Global Questionnaire on Physical Activity (GPAQ)
The Global Physical Activity Questionnaire was developed by WHO for physical activity surveillance in countries. It collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions (P1-P16). The domains are:
- Activity at work
- Travel to and from places
- Recreational activities METs (Metabolic Equivalents) are commonly used to express the intensity of physical activities, and are also used for the analysis of GPAQ data. Therefore, when calculating a person's overall energy expenditure using GPAQ data, 4 METs get assigned to the time spent in moderate activities, and 8 METs to the time spent in vigorous activities.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gustavo Plaza Manzano, Pt PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880370
- Sponsor's protocol ID
- 19/044-E_Tesis
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 22 Mar 2019
- Results posted
- 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 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELATIONSHIP OF LUMBOPELVIC MUSCULATURE WITH FUNCTIONAL TESTS IN NON-PROFESSIONAL ATHLETES WITH LUMBAR DISC HERNIATION
- ClinicalTrials.gov ID
- NCT03880370
- Acronym / sponsor ID
- 19/044-E_Tesis
- Conditions
- Low Back Pain, Herniated Lumbar Disk, Sciatica
- Keywords
- ultrasound, functional test, herniated lumbar disk, low back pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Mar 2019 (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.
This is a control-case study. It has been designed to determine if there is a relationship between the cross sectional (thickness), through RUSI ultrasound, of the abdominal muscles, lumbar and hip muscles with the results of the functional tests, to determine its relevance in patients with low back pain and / or ciatalgia and lumbar disc herniation in non-professional athletes. The secondary objectives of the study will be to know if there is a relationship between the results of ultrasound measurements and functional tests with the result of the disability questionnaires, the amount of pain and its location, as well as determine the relevance, depending on the results of ultrasound measurements and test of the presence or not of a lumbar disc herniation.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1(group without low back pain) | – | Behavioral: Questionnaires / scales, Diagnostic Test: Ultrasound imaging, Diagnostic Test: FLEXIBILITY, Diagnostic Test: FUNCTIONAL TESTSParticipants inclusion criteria an age 18 to 55 years of age who practice sports equal to greater than three hours per week who have not had low back pain or ciatalgia in the last 12 months. |
| group 2 (low back pain group) | – | Behavioral: Questionnaires / scales, Diagnostic Test: Ultrasound imaging, Diagnostic Test: FLEXIBILITY, Diagnostic Test: FUNCTIONAL TESTSParticipants inclusion criteria an age 18 and 55 years of age who practice sports equal to greater than three hours a week, with a history of at least one episode of low back pain and / or ciatalgia in the last 12 months lasting no longer than three months and diagnosis of hernia lumbar disc using MRI. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Men and women between 18 and 55 years old. Non-professional sports practice equal to greater than 3 hours per week
Key inclusion criteria (3 listed)
- Age 18 to 55 years of age.
- Sports practice equal to greater than three hours per week.
- No low back pain or ciatalgia in the last 12 months.
Key exclusion criteria (9 listed)
- Traumatic process or surgery in the lower back or lower limb in the last year.
- Alterations of the skin or local infection in the area to be examined or that impedes the ultrasonographic measurement or performance of the functional tests.
- Peripheral or central neurological pathology.
- Psychiatric pathology and / or cognitive alterations.
- Inflammatory and tumor diseases.
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 |
|---|---|---|
| Questionnaires / scalesEVA, ROLAND MORRIS, OWESTRY and Global Questionnaire of Physical Activity (GPAQ) | Behavioural | group 1(group without low back pain), group 2 (low back pain group) |
| Ultrasound imagingRectus abdominis dominant side \& non-dominant side external oblique dominant side \& non-dominant side internal oblique dominant side \& non-dominant side transversus abdominis dominant side \& non-dominant side lumbar multififidus l4-l5-s1 gluteus medius dominant side \& non-dominant side | Diagnostic test | group 1(group without low back pain), group 2 (low back pain group) |
| FLEXIBILITYweight-bearing lunge hip lateral rotation straight leg raise fingertip to floor test | Diagnostic test | group 1(group without low back pain), group 2 (low back pain group) |
| FUNCTIONAL TESTSStar excursion balance test (sebt) prone bridging test Side bridging test Modified biering-sørensen | Diagnostic test | group 1(group without low back pain), group 2 (low back pain group) |
Primary outcome
Ultrasound changes in muscle cross-sectional area produced of the transversus abdominis.
Time frame: 5 minutes
Ultrasound changes in muscle cross-sectional area produced of the transversus abdominis.
Ultrasound changes in muscle cross-sectional area (CSA) produced of the internal oblique.
Time frame: 5 minutes
Ultrasound changes in muscle cross-sectional area (CSA) produced of the internal oblique.
Ultrasound changes in muscle cross-sectional area (CSA)produced of the external oblique.
Time frame: 5 minutes
Ultrasound changes in muscle cross-sectional area (CSA) produced of the external oblique.
Ultrasound changes in muscle cross-sectional area (CSA)produced of the rectus abdominis.
Time frame: 5 minutes
Ultrasound changes in muscle cross-sectional area (CSA)produced of the rectus abdominis.
Ultrasound changes in muscle cross-sectional area (CSA)produced of the lumbar multifidus.
Time frame: 5 minutes
Ultrasound changes in muscle cross-sectional area (CSA)produced of the lumbar multifidus.
9 secondary outcomes
Ultrasound changes in muscle cross-sectional area (CSA) produced of the gluteus medius.
Time frame: 10 minutes
Functional test. Star excursion balance test (SEBT)
Time frame: 10 minutes
Functional test. Side bridging test
Time frame: 10 minutes
Functional test. Modified biering-sørensen
Time frame: 10 minutes
Functional test. Prone bridging test
Time frame: 10 minutes
VAS escale
Time frame: 1 minute
Roland-Morris Disability Questionnaire
Time frame: 5 minutes
The Owestry Disability Index
Time frame: 5 minutes
Global Questionnaire on Physical Activity (GPAQ)
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- 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.
Gustavo Plaza Manzano, Pt PhD principal investigator
Universidad Complutense de Madrid
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Herniated Lumbar Disk, run by Universidad Complutense de Madrid.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Miñambres Martin, Pt (+34 675 887 126, dminambr@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound changes in muscle cross-sectional area produced of the transversus abdominis. (time frame: 5 minutes). The study lists 5 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 22 Mar 2019.