Trial document





This trial has been registered retrospectively.
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  DRKS00012252

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Resulting from previous research findings on myofascial structures the use of myofascial treatment alongside physical training in leisure and competitive exercise has become increasingly popular. In terms of therapy, specially developed devices are being used to treat myofascial tissue at a deeper and more extensive level and in a more targeted manner. So far, little is known about their actual benefits. Therefore, the aim of this study is to examine the effects on instrument-assisted soft tissue treatment at the lower back of healthy athletes.
The study will include athletes between the ages of 15 and 35. Alongside their regular training sessions of a minimum of 3 x 90 minutes per week, they are expected to practice their sport at a competitive level. In addition, they should be fit, healthy and free from any acute musculoskeletal injuries, should not have had any back complaints in the past four weeks and should not be suffering from any chronic diseases.
The focus of this research will be to detect any changes in tissue consistency, pain perception and functional and structural mobility in those participants subjected to the instrument-assisted treatment (group A). Two control groups will be established (group B: heat; group C: placebo-ultrasound). Group A will receive a standardized treatment at the lower back using a specially designed tool made from surgical steel. Group B will receive a heat treatment by placing a hot pack on the lower back, while group C will receive an ultrasound treatment by a therapeutically inactive ultrasound scanner. In each case the treatment will be applied on the right side of the lower back for one time for a period of eight minutes. The following procedure to determine the effects of the treatment will be identical for all three groups, with measurements taken at three time points (immediately before, immediately after and 45 minutes after the end of the treatment) and from both sides of the body. Prior to this each participant’s height, weight and body composition will be recorded; additionally, skin fold thickness at the area which shall be treated will be assessed. During the three measurement cycles, participants will undergo a measurement of muscle tension at rest, a segmental measurement of electric tissue resistance, a temperature reading and the generation of a thermal image. Furthermore, tissue rigidity and pressure pain will be measured, followed by a diagnostic ultrasound reading and tests to measure mobility of the hip joint, the lumbar and the thoracic spine. In addition to these single interventions, participants in group A will undergo ten instrument-assisted treatments over a period of five weeks to assess the long-term effects. Their results will be compared with those of control-group C, which will continue to participate in the additional measurement procedures but will receive no more placebo treatment.

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Brief Summary in Scientific Language

Resulting from the previous research findings on myofascial structures the use of myofascial treatment alongside physical training in leisure and competitive exercise has become increasingly popular. In terms of therapy, specially developed devices are being used to treat myofascial tissue at a deeper and more extensive level and in a more targeted manner. So far, little is known about their actual benefits. Therefore, the aim of this study is to research the effects on instrument-assisted soft tissue treatment at the lower back of healthy athletes.
The study will include athletes between the ages of 15 and 35. Alongside their regular training sessions of a minimum of 3 x 90 minutes per week, they are expected to practice their sport at a competitive level. In addition, they should be healthy and free from any acute musculoskeletal injuries, should not have had any back complaints in the past four weeks and should not be suffering from any chronic diseases.
The focus of this research will be to detect any changes in tissue consistency, pain perception and functional and structural mobility in those participants subjected to the instrument-assisted treatment (group A). Two control groups will be established (group B: heat; group C: placebo-ultrasound). Group A will receive a standardized treatment at the lower back using a specially designed tool made from surgical steel. Group B will receive a heat treatment by placing a hot pack on the lower back, while group C will receive an ultrasound treatment by a therapeutically inactive ultrasound scanner. In each case the treatment will be applied on the right side of the lower back for one time for a period of eight minutes. The following procedure to determine the effects of the treatment will be identical for all three groups, with measurements taken at three time points (immediately before, immediately after and 45 minutes after the end of the treatment) and from both sides of the body. Prior to this, each participant’s height and weight will be recorded followed by a medical bio-impedance analysis and a caliper measurement to determine the skin fold thickness at the area which shall be treated. During the three measurement cycles, participants will undergo an electromyography, a segmental bio-impedance measurement, a temperature reading and the generation of a thermal image. Furthermore, an indentometry measurement will be taken to read tissue rigidity and an algometry measurement to determine pressure pain threshold, followed by a diagnostic ultrasound reading (thickness, stiffness and shear motion of the myofascial tissue layers) and tests to measure mobility of the hip joint, the lumbar and the thoracic spine. In addition to these single interventions, participants in group A will undergo ten instrument-assisted treatments over a period of five weeks to assess the long-term effects. Their results will be compared with those of control-group C, which will continue to participate in the additional measurement procedures but will receive no more placebo treatment.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012252
  •   2018/06/20
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  •   yes
  •   Approved
  •   080/2017, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

  •   U1111-1196-4167 
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Health Condition or Problem studied

  •   healthy athletes
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Interventions/Observational Groups

  •   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 intervention protocol corresponds approximately eight minutes and includes two different techniques. In doing so, the treatment tool will be jerked firstly and in the second technique moved slowly from different directions through the tissue. The procedure to determine the effects of the treatment will be identical for all three groups, with measurements taken at three time points (immediately before, immediately after and 45 minutes after the end of the treatment) and from both sides of the body. In addition to these single interventions, participants in group A will undergo ten instrument-assisted treatments over a period of five weeks to assess the long-term effects. Their results will be compared with those of control-group C, which will continue to participate in the additional measurement procedures but will receive no more placebo treatment.
  •   Control group B: Hot-pack-intervention of the lower back for eight minutes
  •   Control group C: Placebo intervention of the lower back with a inactivated, therapeutic ultrasound device for eight minutes
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Placebo, Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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 Outcome

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 adjacent area, one 2.5 cm laterally to the spinous process Th 6 and the other 20 cm distally to the tuber ischiadicum on the line connecting the tuber ischiadicum and the center of the popliteal area. The fourth measurement point will represent a reference point which will be situated on the contralateral M. triceps brachii 10 cm cranially to the olecranon on the line connecting the olecranon and the dorso-lateral corner of the acromion. The measurements which will be taken at all four points will represent the force shown in Newton at a penetration depth of 10 mm as well as the depth of penetration into the tissue at the pressure pain threshold in millimeters and the pressure applied per area (N∙(cm²)-1). For this research, the pressure pain threshold will be defined as an entering pain as a result of the constant increase in pressure of 5 Newton per second (N∙s-1) and should be clearly differentiated from a feeling of pressure. In this study, the force applied per area at the pressure pain threshold will represent the algometry measurement.

To determine the electrical resistance of the paravertebral structures of the lumbar spine, a segmental bio-impedance analysis will be carried out. For this purpose, two additional electrodes (measurement electrodes) will be applied on the athletes’ backs. One of the electrodes will be placed 1 cm laterally to the spinous process Th12 and the other will be placed 1 cm laterally to the center line of the sacrum adjacent to the sacrum base. For the energized pair of electrodes, the respective proximal hand- and foot-electrode of the medical bio-impedance measurement test will be used, which are attached accordingly to the left side of the body. The combined electrical resistance (the reactance and resistance) of the paravertebral structures between the electrodes will be measured in Ohm (Ω) together with the corresponding phase angle in degrees (°).

The EMG measurement (NeuroTrac Simplex, Verity Medical ltd.) will determine the muscle tone at rest. For this purpose, one of the two electrodes will be applied 1 cm laterally to the thoracic spine and 1 cm cranially to the upper electrode of the impedance measurement. The second electrode will be attached 1 cm laterally to the center line of the sacrum and 1 cm caudally to the lower electrode (of the impedance measurement). The corresponding reference electrode will be placed centrally on the right M. triceps brachii on the line connecting the dorso-lateral corner of the acromion and the olecranon. The electrical activity of the muscular system will be measured in microvolt (µV).
The body temperature will be taken at the same measurement points as the indentometric procedure in degrees centigrade (°C) using a multifunctional thermometer.

A specially designed questionnaire will provide information on the athletic career and lifestyle of each participant as well as any changes he or she will perceive subjectively by the long-term effect of the instrument-assisted myofascial interventions.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/10/30
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   15   Years
  •   35   Years
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Additional 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

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Exclusion Criteria

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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Physiotherapie Weber
    • 50354  Hürth
    • Germany
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    • Physiotherapie Weber
    • Mr.  M.Sc.  Patrick  Weber 
    • Decksteiner Straße 77
    • 50354  Hürth
    • Germany
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    • Physiotherapie Weber
    • Mr.  M.Sc.  Patrick  Weber 
    • Decksteiner Straße 77
    • 50354  Hürth
    • Germany
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Sources of Monetary or Material Support

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    • Physiotherapie Weber
    • Mr.  M.Sc.  Patrick  Weber 
    • 50354  Hürth
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.