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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03880370
Other study ID # 19/044-E_Tesis
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date December 31, 2019

Study information

Verified date March 2019
Source Universidad Complutense de Madrid
Contact Diego Miñambres Martin, Pt
Phone +34 675 887 126
Email dminambr@ucm.es
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaires / scales
EVA, ROLAND MORRIS, OWESTRY and Global Questionnaire of Physical Activity (GPAQ)
Diagnostic Test:
Ultrasound imaging
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
FLEXIBILITY
weight-bearing lunge hip lateral rotation straight leg raise fingertip to floor test
FUNCTIONAL TESTS
Star excursion balance test (sebt) prone bridging test Side bridging test Modified biering-sørensen

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad Complutense de Madrid

Outcome

Type Measure Description Time frame Safety issue
Primary Ultrasound changes in muscle cross-sectional area produced of the transversus abdominis. Ultrasound changes in muscle cross-sectional area produced of the transversus abdominis. 5 minutes
Primary 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. 5 minutes
Primary 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. 5 minutes
Primary 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. 5 minutes
Primary 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. 5 minutes
Secondary 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. 10 minutes
Secondary 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
10 minutes
Secondary 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
10 minutes
Secondary 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
10 minutes
Secondary 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
10 minutes
Secondary 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.
1 minute
Secondary 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). 5 minutes
Secondary 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.
5 minutes
Secondary 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.
5 minutes
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