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Study Participation

For this study we are looking for people aged 18 to 64 years:

-who do not suffer from back pain
-who suffer from chronic lower back pain (>3 months)

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Inclusion criteria & study procedure

You are eligible to participate in the study if you are

  • are not currently participating in any other study
  • are not a professional, competitive or elite athlete
  • are not overweight
  • are not pregnant
  • do not suffer from rheumatism, osteoporosis or acute infections
  • do not suffer from any active systemic diseases (e.g. tuberculosis, collagenosis, multiple sclerosis, autoimmune diseases, acquired immune deficiency syndrome)
  • have no internal diseases that pose a potential risk during the measurements (e.g. heart disease) and/or influence the findings
  • have had no previous spinal surgeries; and
  • have no abnormal posture or lower limb anomalies.

How does the study proceed?

The study takes about 180 min in total and is divided in time as follows:

1) Medical history (day 1).

The anamnesis (medical history) focuses in particular on risk factors with an urgent need for treatment (such as bone fractures, osteoporosis, infection, tumour), psychosocial risk factors (such as depression, passive pain behaviour) and workplace-related risk factors (such as heavy physical work). You will then be asked to complete questionnaires about your health status or back pain, your physical activity and your motivation to be physically active.

2) Physical (clinical) examination (day 1)

The clinical examination includes assessment of your organ functions, vital signs (temperature, heart rate, blood pressure), neurological functions (coordination, reflexes, sensitivity) and posture, shape, orientation and movement of the lumbar spine.

Based on the inclusion and exclusion criteria and your findings, it will be clarified whether you can take part in further examinations.

3) Back shape measurement (day 1)

First, your vertebral bodies are marked from C7 (lowest cervical vertebra) to S3 (middle sacral vertebra). C7 and S3 are the starting and end points of the measurement. You are then measured in a relaxed standing position, in maximum forward and backward flexion. During the static position, the examiner moves the MediMouse along the marked lines. This measurement is repeated five times.

4) Magnetic resonance imaging (day 2)

MRI diagnostics provide images of your spine and the surrounding tissues, as well as of injuries or malpositions. Before the MRI examination, you will be provided with markers on your skin so that we can match the subsequent back measurements with the spinal structures. These skin markers are applied (painlessly) over the lumbar spine.

5) Gait analysis (day 2)

The movements of the ankle, knee and hip joints as well as individual segments of the spine are measured in order to identify possible abnormalities in gait and to what extent these affect the back. We use optical methods to record the movement of individual joints. Marker movements are recorded with cameras. Based on the marker positions in the individual camera images, the movement can be calculated.

6) Back function measurement (day 2)

A special hollow plaster (painless) is stuck to your back on both sides of the spine. A sensor band is inserted into each of these. You will then be asked to bend as far as possible forwards, backwards and to both sides, and to rotate your upper body to the left and right. Each exercise is repeated three times.

Basic examination completed.

7) Long-term functional measurement (24-hour measurement)

For selected study participants, we also offer long-term functional analyses. These long-term measurements will be used in the future to diagnose back diseases. Beforehand, it is necessary to record the movement patterns of many people in order to determine normal values. For this purpose, you will be equipped with 3 systems. The selection procedure for these examinations is random.
-Long-term - back function

After the back function measurement (see previous page), the measuring system remains on your back for 24 hours. The measurement system continues to record upper body movements.
-Physical activity

Daily physical activity is determined with the help of a pedometer (= pedometer), which is attached to a belt or the waistband of your trousers.
-walking and physical activity behaviour

The study participants are also equipped with instrumented shoe insoles that provide information about the user's gait and movement behaviour.

They will be asked to return to the Charité after about 24 hours to have the measurement systems removed. These measurements will be repeated three times on different days within 14 days. For this purpose, the back function measurement described above (20 min) is carried out before each long-term examination. This is necessary because we have to relate the results of your long-term analyses to the short-term clinical analyses. After the back function measurement, the measurement systems remain on your back again for 24 hours. At the end of the 24-hour measurement, you will return to the Charité to have the measurement system removed.

We ask you to wear short and tight-fitting trousers for the measurement. Men are asked to take the measurements with their upper body exposed, women with a sports bra.

You will receive more detailed information from our experts on site.

Registration

The contact details will be published from 01.01.2022.