M50 M51 M53 M54
Conditions
Interventions
Group 1: The low-risk group (G2: unimodal) contains during the rehabilitation period exclusively sensorimotor training.
The training is learned during the rehabilitation phase and should be completed
Sponsors
Universität Potsdam, Abteilung für Medizinische Soziologie und Psychobiologie
Eligibility
Sex/Gender
All
Age
25 Years to 60 Years
Inclusion criteria
Inclusion criteria: The sample includes male and female patients from 25 to 60 years old with the diagnoses ICD-10 M50-54
Exclusion criteria
Exclusion criteria: - < 6 months post operative - Acute infection/ cold - Pregnancy - Inflammatory rheumatic disease - Serious neurological disease (e.g. dementia (ICD-10 F00-F03), Alzheimer's, epilepsy) - Serious psychiatric illness (e.g. schizophrenia (ICD-10 F20), dysthymia (F34.1), emotionally unstable personality disorders such as borderline disorders (ICD-10 F60.3x),) - Intellectual impairment (like ICD-10 F70 to F79) - Language limitations (e.g. reduced German knowledge) - not able to stand and/or contraindication(s) to exercise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main objektives Upon admission into the rehabilitation center a clinical examination (regular orthopedic examination) is performed. After reviewing inclusion and exclusion criteria and subjects' consent to participate in the study the psychosocial risk screenings (“RSI” and “RPI-S”) and target criteria measurements (t0) are collected. The target criteria pain and impairment status are assessed using standardized questionnaires whereby the type (chronic/acute) and localization of pain are collected in a differential manner. The second target criteria is defined as the ability to function and participate, and is collected via days of work incapacity, work ability, and the subjective prognosis of employment (Subjective prognosis of gainful employment and Work Ability Index short form). In addition, functional parameters for testing mobility (Timed up and Go Test TUG, Chair-Rise-Test, one-legged stance test assessing neuromuscular control, trunk coordination as well as trunk mobility) are obtained in the clinics. These parameters can be measured again during the follow-up visits to the centers. The neuromuscular performance is assessed by COP Track measurements on the balance board in the one-legged stand. The mobility of the torso is determined by controlled bending of the trunk from an upright standing position, where the maximum extent of trunk flexion is measured by two acceleration sensors (Biovision, Wehrheim; size 1x1x1 cm, 1000 Hz, sensor position on pelvis below the sacrum and another sensor on the vertebral body of the 12th thoracic vertebra). The coordination of the pelvis and lumbar spine is determined by the ratio of lumbar spine rotation to pelvic rotation (lumbo-pelvic ratio, LPR) in the sagittal plane during maximum protrusion. The same test setup is used to measure the LPR as used to determine the range of motion of the trunk. The local dynamic stability of complex trunk movements is quantified by the method of non-linear time series analysis. For this | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives include exercise behavior (International Physical Activity Questionnaire; IPAQ), subjective well-being regarding stress, anxiety and depression (Trier Inventory for the assessment of Chronic Stress; TICS, Hospital Anxiety and Depression Scale; HADS), the Fear Avoidance Beliefs Questionnaire (FABQ-D) and health-related quality of life (Short form 12 Health Survey; SF-12). Furthermore, living context questions such as socioeconomic status and social support (Berlin Social Support Scale: BSSS) and patient satisfaction with the program will be collected. In order to assess the initial health status and later intervention success, the clinical data available during the initial clinical examination (regular orthopedic examination) and already documented clinical data concerning disease duration, previous therapies/medication, basic physiological status (RR, BMI, blood lipids) are collected. The therapy adherence is continuously monitored in the IRENA and home activity program though training diaries. In these diaries frequency and level of difficulty of the exercises are recorded as well as the degree of pain using an NRS scale (Numeric Rating Scale). Surveys from time 0 (t0) to time 3 (3) are online surveys developed in cooperation with the partner ProWebDB, which has experience in clinical trials. | — |
Countries
Germany
Contacts
Public ContactFelix Bestgen
Universität Potsdam, Abteilung für Medizinische Soziologie und Psychobiologie
Outcome results
None listed