- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03880370
RELATIONSHIP OF LUMBOPELVIC MUSCULATURE WITH FUNCTIONAL TESTS IN NON-PROFESSIONAL ATHLETES WITH LUMBAR DISC HERNIATION
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
EVA, ROLAND MORRIS, OWESTRY and Global Questionnaire of Physical Activity (GPAQ)
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
weight-bearing lunge hip lateral rotation straight leg raise fingertip to floor test
Star excursion balance test (sebt) prone bridging test Side bridging test Modified biering-sørensen
|
|
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.
|
EVA, ROLAND MORRIS, OWESTRY and Global Questionnaire of Physical Activity (GPAQ)
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
weight-bearing lunge hip lateral rotation straight leg raise fingertip to floor test
Star excursion balance test (sebt) prone bridging test Side bridging test Modified biering-sørensen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 minutes
|
|
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.
|
5 minutes
|
|
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.
|
5 minutes
|
|
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.
|
5 minutes
|
|
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.
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasound changes in muscle cross-sectional area (CSA) produced of the gluteus medius.
Time Frame: 10 minutes
|
Ultrasound changes in muscle cross-sectional area (CSA) produced of the gluteus medius.
|
10 minutes
|
|
Functional test. Star excursion balance test (SEBT)
Time Frame: 10 minutes
|
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 |
10 minutes
|
|
Functional test. Side bridging test
Time Frame: 10 minutes
|
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 |
10 minutes
|
|
Functional test. Modified biering-sørensen
Time Frame: 10 minutes
|
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 |
10 minutes
|
|
Functional test. Prone bridging test
Time Frame: 10 minutes
|
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 |
10 minutes
|
|
VAS escale
Time Frame: 1 minute
|
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. |
1 minute
|
|
Roland-Morris Disability Questionnaire
Time Frame: 5 minutes
|
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).
|
5 minutes
|
|
The Owestry Disability Index
Time Frame: 5 minutes
|
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. |
5 minutes
|
|
Global Questionnaire on Physical Activity (GPAQ)
Time Frame: 5 minutes
|
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:
|
5 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gustavo Plaza Manzano, Pt PhD, Universidad Complutense de Madrid
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Neuromuscular Diseases
- Sciatic Neuropathy
- Mononeuropathies
- Peripheral Nervous System Diseases
- Neuralgia
- Pathological Conditions, Anatomical
- Spinal Diseases
- Bone Diseases
- Hernia
- Back Pain
- Low Back Pain
- Sciatica
- Intervertebral Disc Displacement
Other Study ID Numbers
- 19/044-E_Tesis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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