The influence of an instrument-assisted, myofascial treatment of the lumbar spine on structural and functional properties of the lower back.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012252

Enrollment

150

Registered

2018-06-20

Start date

2017-10-30

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy athletes

Interventions

Group 1: Intervention group A: Consists of a standardised, single, instrument-assisted, myofascial treatment of the lower back using a specially designed tool made from surgical steel. The interventio

Eligibility

Sex/Gender

All

Age

15 Years to 35 Years

Inclusion criteria

Inclusion criteria: male and female athlets at the age of 15 up to 35; do their sports competition oriented; at least three training sessions about 90 minutes per week, sport-healthy

Exclusion criteria

Exclusion criteria: Acute injuries of the musculoskeletal system; chronic diseases; back pain for the last four weeks

Design outcomes

Primary

Measure	Time frame
Primary endpoint will be the thickness, stiffness and shear motion of the tissue layers of the thoracolumbar structures measured by ultrasound in millimeters (mm). This will be assessed at baseline, immediately after and 45 minutes after the treatment. For this purpose, a linear 3.8 cm ultrasound transducer will be aligned longitudinally and placed centrally with its medial edge, 2 cm laterally to the interspinous space of L2/L3. This will be recorded by a single ultrasonic beam focused on the thoracolumbar fascia at a depth of 3.2 cm. During the measurement, the treatment table will be turned around its rotation axis electrically between the base and the center into a so-called roof position of 45 degrees. This will result in a passive flexion of the torso at the level of the spina iliac anterior superior. An ultrasound recording will be taken for the total duration of the movement via a cine-loop function, from which the measurement parameters mentioned above will be generated. After this, the treatment table will be moved back into its initial position and the tissue rigidity of the lower back will be determined by a specific force gauge (F100, Sauter) attached to the ultrasound transducer. Therefore, an ultrasound image of the initial position as well as a second image of a pressure application of 5 Newton (N) (± 0.25) to the ultrasound transducer and a third image of 10 N (± 0.25) will be taken. Following this, the thickness of each individual tissue layer will be measured three times in millimeters, without and with both of the two different pressure applications. The difference between these measurements (with and without applied pressure) provides information on tissue rigidity (Jafari et al. 2017).	—

Measure

Time frame

Primary endpoint will be the thickness, stiffness and shear motion of the tissue layers of the thoracolumbar structures measured by ultrasound in millimeters (mm). This will be assessed at baseline, immediately after and 45 minutes after the treatment. For this purpose, a linear 3.8 cm ultrasound transducer will be aligned longitudinally and placed centrally with its medial edge, 2 cm laterally to the interspinous space of L2/L3. This will be recorded by a single ultrasonic beam focused on the thoracolumbar fascia at a depth of 3.2 cm. During the measurement, the treatment table will be turned around its rotation axis electrically between the base and the center into a so-called roof position of 45 degrees. This will result in a passive flexion of the torso at the level of the spina iliac anterior superior. An ultrasound recording will be taken for the total duration of the movement via a cine-loop function, from which the measurement parameters mentioned above will be generated. After this, the treatment table will be moved back into its initial position and the tissue rigidity of the lower back will be determined by a specific force gauge (F100, Sauter) attached to the ultrasound transducer. Therefore, an ultrasound image of the initial position as well as a second image of a pressure application of 5 Newton (N) (± 0.25) to the ultrasound transducer and a third image of 10 N (± 0.25) will be taken. Following this, the thickness of each individual tissue layer will be measured three times in millimeters, without and with both of the two different pressure applications. The difference between these measurements (with and without applied pressure) provides information on tissue rigidity (Jafari et al. 2017).

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Secondary

Measure	Time frame
The secondary endpoints will be based on mobility tests for the hip, the lumbar and the thoracic spine as well as the results of an indentometry and algometry measurements. In addition, a segmental bio-impedance analysis and electromyography will be performed, body temperature will be taken and data will be derived from a specifically developed questionnaire. To determine hip mobility, the investigator will perform a passive Straight Leg Raise Test on the participant in a supine position. The movement will be performed until the palpation hand, placed at the pelvis, will detect a pelvic rotation or a firm resistance. The hip flexion will be measured in degree in a neutral pelvic position and straight legs. For the lumbar and thoracic spine, a double inclinometer measurement will be taken on the participant in an upright position. The first inclinometer will be placed centrally on the sacrum, bordering on the base of the sacrum. The second has its contact points on the spinous processes Th12 and L1. To take the measurements of the thoracic spine, the inclinometer will remain on Th12 and L1, while the second will be placed with its contact points on the spinous processes Th1 and Th2. During both measurement cycles, the participant will firstly perform a maximum passive and then active flexion of the upper part of the body from an upright position. For this purpose, the participant will allow the upper part of its body to be brought into flexion passively following the law of gravity, followed by muscle activation to reach the maximum of flexion. The extent of mobility of the lumbar and thoracic spine will be measured in degrees (°). Indentometry will be performed using an indentometer and will define the stiffness of the tissue at four different points. First of all, the measurements will be taken in the treated area 2.5 cm laterally to the interspinous space of the spinous processes L2 and L3. Additional measurements will then be taken at two points in the adjac	—

Measure

Time frame

The secondary endpoints will be based on mobility tests for the hip, the lumbar and the thoracic spine as well as the results of an indentometry and algometry measurements. In addition, a segmental bio-impedance analysis and electromyography will be performed, body temperature will be taken and data will be derived from a specifically developed questionnaire. To determine hip mobility, the investigator will perform a passive Straight Leg Raise Test on the participant in a supine position. The movement will be performed until the palpation hand, placed at the pelvis, will detect a pelvic rotation or a firm resistance. The hip flexion will be measured in degree in a neutral pelvic position and straight legs. For the lumbar and thoracic spine, a double inclinometer measurement will be taken on the participant in an upright position. The first inclinometer will be placed centrally on the sacrum, bordering on the base of the sacrum. The second has its contact points on the spinous processes Th12 and L1. To take the measurements of the thoracic spine, the inclinometer will remain on Th12 and L1, while the second will be placed with its contact points on the spinous processes Th1 and Th2. During both measurement cycles, the participant will firstly perform a maximum passive and then active flexion of the upper part of the body from an upright position. For this purpose, the participant will allow the upper part of its body to be brought into flexion passively following the law of gravity, followed by muscle activation to reach the maximum of flexion. The extent of mobility of the lumbar and thoracic spine will be measured in degrees (°). Indentometry will be performed using an indentometer and will define the stiffness of the tissue at four different points. First of all, the measurements will be taken in the treated area 2.5 cm laterally to the interspinous space of the spinous processes L2 and L3. Additional measurements will then be taken at two points in the adjac

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Countries

Germany

Contacts

Public ContactPatrick Weber

Physiotherapie Weber

weberpatrick87@gmx.de004922336280730

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 27, 2026