Trial document




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  DRKS00021696

Trial Description

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Title

A multimodal intervention approach for cross-sectoral care of degenerative diseases of the spine

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Trial Acronym

MultiMove

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to investigate the effectiveness of a multimodal exercise program specifically designed for patients with a degenerative spinal disease and chronic low back pain. Degenerative changes in the spine are understood to be age- and stress-related changes in the intervertebral discs, vertebral bodies and vertebral joints. These changes are often accompanied by initially acute and then chronic low back pain. The pain experience cannot be clearly attributed to a specific nociceptive source, but is influenced by various biological, psychological and social aspects. Therefore, the pain is not only perceived as a physical limitation, but is accompanied by further psychological and social limitations and finally reduces the quality of life. Consequently the pain needs to be addressed in its complexity. Therefore a multimodal movement therapy "MultiMove" was developed. It includes specific strengthening exercises for the trunk muscles, balance, coordination and cognition exercises.
In the study, patients take part in the MultiMove twice a week for 12 weeks in addition to the standard therapy (physiotherapy and pain therapy). It is expected that patients will show a significant increase in mobility and thus a reduction in pain and an improved quality of life through the movement intervention.

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Brief Summary in Scientific Language

The aim of the project is to investigate the efficacy of a multimodal exercise program specifically designed for patients with cdegenerative spinal disease and chronic low back pain. With a lifetime prevalence of about 85 %, low back pain represents not only an individual but also an economic health problem. The chronic course of low back pain in particular is associated with an increased number of days of incapacity to work and early retirement. While chronic low back pain has various aetilogical causes, in many cases it cannot be clearly attributed to a specific nociceptive source. Degenerative spinal diseases are often associated with chronic low back pain. In addition to the pain, these patients show insufficient muscular stabilization, impaired balance and a changed gait pattern. Furthermore, the impairment is not only perceived on a physical but also on a psychological level, which influences the overall quality of life. International and national guidelines for treatment of chronic low back pain show that the current treatments only provide small to moderate and short-term effects. They also recommend a multimodal approach for rehabilitation. Considering the factors which increase the risk of a chronic condition, not only workplace-related risk factors are mentioned , but also psychosocial (e.g. poor cognitive functioning) and individual factors (e.g. weakness of the back and abdominal muscles) are emphasised. Therefore, a multimodal exercise program was developed for the project, called MultiMove, that directly addresses psychosocial and individual risk factors. Here, a dance-therapeutic approach forms the core element of the intervention, since dancing automatically requires functional mobility, coordinative and cognitive skills as well as social interactions. Furthermore, dance-therapeutic interventions have already been successfully used for healthy elderly people and in the field of neurological rehabilitation. The dance intervention will be accompanied by exercises targeting the deep muscles of the back and coordinative-cognitive tasks, in order to address the individual and psychosocial risk factors described above. MultiMove will be evaluated as a randomized controlled study in three consecutive phases. The aim is to contribute to a networked, multidisciplinary care of elderly people (> 50 years) with degenerative spinal diseases. For this purpose, MultiMove will be compared in the first phase together with the conservative standard treatment (physio-/pain therapy), while in the second phase the movement intervention will be tested in the context of inpatient rehabilitation. After successful implementation of MultiMove in rehabilitation, the program will be transferred in the third phase to medical prevention. Due to the treatment, we expect an improved mobility (e.g. Timed Up-and-Go Test - TUG) as well as a pain reduction (e.g. Oswestry Disability Index - ODI). This is expected to be associated with an improved quality of life (e.g. European Quality of Life 5 Dimensions 5 Level Version - EQ-5D-5) also in the long term (follow-up 3 months).

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

Yes

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Description IPD sharing plan:

can be provided upon request

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Organizational Data

  •   DRKS00021696
  •   2020/07/10
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  •   yes
  •   Approved
  •   182/18, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

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Health Condition or Problem studied

  •   M54 -  Dorsalgia
  •   M48.0 -  Spinal stenosis
  •   M54.5 -  Low back pain
  •   M54.4 -  Lumbago with sciatica
  •   M54.16 -  [generalization M54.1: Radiculopathy]
  •   M41.5 -  Other secondary scoliosis
  •   M43.1 -  Spondylolisthesis
  •   M42.1 -  Adult osteochondrosis of spine
  •   M51.2 -  Other specified intervertebral disc displacement
  •   M47.8 -  Other spondylosis
  •   M53.2 -  Spinal instabilities
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Interventions/Observational Groups

  •   Intervention group: In addition to the standard therapy the patients will participate in the multimodal movement intervention (main focus on dance therapeutic elements combined with strengthening exercises for the back muscles and motor-cognitive exercises) over 12 weeks twice a week.
  •   Control group: Standard physiotherapy and pain therapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Pre (t1), post (t1+3 months) and follow-up measurement (t1+6 months)
1) Instrument: Timed Up-and-Go Test (TUG); Content: mobility, walking ability, balance, risk of falling

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Secondary Outcome

Pre (t1)- Post (t1+3 months) and follow-up (t1+6 months) measurements

Mobility/ Pain:
1) Instrument: Oswestry Disability Index (ODI) by Fairbank et al. (2000) - German version by Mannion et al. (2006); Content: Functional status and quality of life restrictions
2) Instrument: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5); Content: Health Status/Quality of Life 5 Dimensions: Agility/mobility, ability to take care of oneself, everyday activities, pain/ physical complaints and fear/depression
3) Gait analysis with wireless inertial sensors; content: kinematic variables gait speed, double step length, width, cadence; Minimal Toe Clearance (MTC)) and their variability
4) 6-min walking test; contents: gait stability, risk of falling and cardiovascular/pulmonary performance
5)Balance performance assessment on a force plate
6) numerical rating scale (NRS) from 0 - no pain to-10 - pain as bad as it could be ; Content: Subjective perception of pain
7) Deutscher Schmerzfragebogen(German pain questionnaire) (Deutsche Schmerzgesellschaft e.V.: 2015.2); content: individual questions on chronic pain
8) Freiburger Fragebogen zur körperlichen Aktivität (Freiburg questionnaire on physical activity) (Frey et al. 1999); content: self-assessment of everyday activity
9) sensor-based measuring device (mobbe® med) will be used to assess trunk range of motion

Cognition:
1) Performance in the dual-task task (calculating and walking at the same time); Content: estimation of cognitive and motor reserves; ability to perform two tasks simultaneously
2) Functional near-infrared spectroscopy (fNIRS); contents: oxy- and deoxyhaemoglobin concentrations of the prefontal cortex, premotor cortex, supplementary motor areas
3) Farb-Wort-Interferenztest (Colour-word interference test) (FWIT) (Bäumler, 1985); Contents: congruence, incongruence; reaction time (s) - processing speed, influence of stress
4) Trail Making Test (TMT-A, TMT-B; Reitan, 1958); Content: divided attention; executive function

Risk factors for chronic pain
1) Tampa Scale of Kinesiophobia Contents German version (TSK-GV) (Rusu et al., 2014): self-report questionnaire measuring the fear of movement and reinjury
2) Coping Strategies-Questionnaire-German (CSQ-D) version (Original: Rosenstiel and Keefe 1983; German translation by Verra et al. 2006); Content: Coping strategies for chronic pain

Additional measurements:
Level of fatigue and depressive symptoms at measurement day will be estimated trough the fatigue subscale of the Profile of Mood States (POMS-F) (MCNair, Lorr & Dropplemann,1992) and the Beck Depression Inventory II (BDI-II) (Hautzinger, Keller & Kühner, 2006).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2020/09/01
  •   450
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

- 50 years or older
- Patients with degenerative spinal diseases
- Back pain (for at least 3 months) and/or claudicatio spinalis
- NRS over the last 4 weeks ≥ 4
- Informed consent

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Exclusion Criteria

> 2 previous operations of the spine
- fusion > 3 segments
- Patients with strength reductions < 4/5 (according to Janda)
- Walking aids or free walking distance under 300m
- congenital spinal defects
- neurological diseases (stroke, MS)
- Other diseases (musculoskeletal, cardiovascular, mental) that would prevent the intervention

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Addresses

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    • Otto-von-Guericke Universität Magdeburg, Institut III, Bereich Sportwissenschaft
    • Mr.  Prof. Dr. habil.  Lutz  Schega 
    • Zschokkestr. 32, Gebäude 40-D
    • 39104  Magdeburg
    • Germany
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    • Klinikum Magdeburg gGmbH, Klinik für Orthopädie II
    • Mr.  PD Dr. med. habil.  Jörg  Franke 
    • Birkenallee 34
    • 39130  Magdeburg
    • Germany
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    • Otto-von-Guericke Universität Magdeburg, Institut III, Bereich Sportwissenschaft
    • Ms.  Britta  Kaps 
    • Zschokkestr. 32, Gebäude 40
    • 39104  Magdeburg
    • Germany
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    • Klinikum Magdeburg gGmbh, Klinik für Orthopädie II
    • Ms.  Anne  Wustmann 
    • Birkenallee 34
    • 39130  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • EFRE-Europäischer Fonds für regionale Entwicklung / Investitionsbank Sachsen-Anhalt
    • Domplatz 12
    • 39104  Magdeburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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