Trial document



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  DRKS00028770

Trial Description

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Title

Non-inferiority of a hybrid outpatient rehabilitation due to musculoskeletal disorders: a randomized controlled trial

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Trial Acronym

HIRE

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URL of the Trial

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Brief Summary in Lay Language

The non-inferiority study we are planning compares a hybrid rehabilitation for back pain with digital seminars and rehabilitation in which the seminars are conducted conventionally with face-to-face meetings. The study is planned in the setting of eight outpatient orthopedic rehabilitation centers. Content wise both groups follow the standard therapy (‘curriculum back school’). We examine the non-inferiority of the hybrid rehabilitation model. The digital application is provided by the online therapy platform 'Caspar'. Access is enabled through an app or internet browser. 18 to 65 year old rehabilitants with back pain are included in the study. If the hybrid rehabilitation proves to be as similarly effective as conventional rehabilitation, rehabilitants and rehabilitation centers are provided with an alternative form of rehabilitation that allows for more flexibility in rehabilitation care. Scientific research suggests that telerehabilitation in physical therapy could be comparable to in-person physical therapy or to be better than non-rehabilitation for various musculoskeletal and internal disorders, including back pain. This study is primarily intended to evaluate the effectiveness of a hybrid rehabilitation compared to conventional rehabilitation on pain-specific self-efficacy.

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Brief Summary in Scientific Language

Digital or tele rehabilitative therapy are becoming increasingly important in the rehabilitative setting and open up the opportunity for more flexible implementation of rehabilitation. Over the last decade, the usage of technology in rehabilitation has grown exponentially, paving the way for the development of telerehabilitation. Not least due to the pandemic, digital applications were often the only form of rehabilitative care. Especially in aftercare, tele rehabilitative applications can help to consolidate the achieved treatment success and integrate therapeutic measures in the sense of effective secondary prevention into the everyday life of the rehabilitants. Furthermore, therapy dropout rates can be reduced and therapy accessibility improved. Since approx. 80% of all at least 14-year-olds use the Internet regularly the accessibility of digital applications in the population is assumed to be high. Current studies on digital therapy are mainly limited to rehabilitation aftercare or prevention in the outpatient sector. Nonetheless, scientific research suggests that telerehabilitation in physical therapy may be comparable to in-person physical therapy or to be better than non-rehabilitation for various musculoskeletal and internal disorders, including back pain. The study we are planning compares a hybrid rehabilitation that digitally implements the curriculum ‘back school’ (standard therapy) with a rehabilitation that conventionally implements the curriculum ‘back school’ as face-to-face meetings. The digital application is provided by the online therapy platform 'Caspar'. Access is enabled through an app or internet browser. 18-65-year-old rehabilitants with back pain (ICD-10 M50 to M54, ongoing treatment and subsequent treatment) are included in the study. The project takes place within the framework of a multi-center randomized controlled study. Eight rehabilitation centers are involved and recruit 20 participants for the control and intervention group each (N=320). At four measurement time points (start of rehab, end of rehab, 3 months after the end of rehab, 12 months after the end of rehab), the rehabilitants will be questioned quantitatively using written questionnaires. In order to examine the qualitative structure and processes of the research project, random sample guided interviews with rehabilitants, doctors and therapists will be carried out. Further, the online usage of the digital rehab program by the rehabilitants will be recorded in the Caspar application. As the primary goal, the study compares pain-specific self-efficacy between the hybrid rehabilitation group and the conventional rehabilitation group. As the secondary goal, the study compares additional outcomes, such as: motivation, knowledge, ability to function and work.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00028770
  •   2022/04/05
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  •   yes
  •   Approved
  •   21-462, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  •   U1111-1264-9325 
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Health Condition or Problem studied

  •   M50-M54 -  Other dorsopathies
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Interventions/Observational Groups

  •   The participants in the intervention group are prescribed the curriculum ‘back school’ (C651) from the Bund-Deutsche Rentenversicherung (German Pension Insurance Association, GPIA). It will be realized digitally by using the Caspar application. The back school curriculum consists of seven modules (module 1= basics, module 2= back health and movement behavior, module 3= body perception and spinal column stabilization, module 4= psychological factors, module 5= posture and movement sequences in everyday life and at work, module 6= physical activity in the everyday life part 1, module 7 = physical activity in everyday life part 2), takes three weeks for each participant and is realized within seven meetings (30-60 min. per meeting). The implementation of the modules will be carried out through digital education, interaction, homework and tests for the rehabilitants. Experienced physical therapists will guide the modules. Personal electronic devices of the participants, such as smartphones or laptops, are used to take part in the courses and to follow the modules, which means that they are not tied to a specific location. Therapists and doctors are able to provide multimedia content for the rehabilitants online (e.g. on etiopathology of back pain or physical homework exercises). This digital content is available for the participants of the hybrid rehab at any time. An overview of the content of the modules follows.
  •   The participants in the control group are prescribed the before listed seven modules as curriculum back school (C651) of the GPIA. The curriculum back school represents the standard therapy in all participating rehabilitation centers as face-to-face meetings. The implementation of the modules will be carried out by education, interaction, homework and tests for the rehabilitants, but with analogue materials. Experienced physical therapists will guide the modules.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is pain-specific self-efficacy and is collected by using a questionnaire (FESS) at all four measurement points (start of rehab, end of rehab, 3 months after the end of rehab, 12 months after the end of rehab). A total score is calculated, with a higher value representing a greater degree of pain-specific self-efficacy (range 10 to 60) (Mangels et al. 2009).

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Secondary Outcome

As the secondary goal, the study collects additional data at all four measurement time points by questionnaire. The following categories are included: disorder and treatment knowledge (Meng et al., 2009), cognitive and behavioral pain management (Geissner, 1999), motivational self-efficacy (Schwarzer et al., 2007), work ability (Ilmarinen, 2007), health and functional ability (Wirtz, 2005), general health (Nübling et al., 2005), medical treatment (own construction), occupational situation (own construction), sociodemographic information (Deck & Röckel, 1999), electronic health literacy (Norman & Skinner, 2006), patient satisfaction (Attkisson & Zwick, 1982), information behavior (own construction), report of medical and therapeutic treatment during the rehabilitation (own construction). Furthermore, participants in the intervention group receive questions on practicability (Brooke, 1986; Thielsch, 2017) and user behaviour (own construction) of the digital application.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2022/04/11
  •   320
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Rehabilitants with back pain are included (ICD-10 M50 to M54, ongoing treatment and subsequent treatment).

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Exclusion Criteria

Rehabilitants without a stable internet connection, without an appropriate electronic device for playing internet browser or app-related videos and without a suitable camera for communication purposes as well as a lack of German language skills are excluded.

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Addresses

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    • Universität zu Lübeck
    • Mr.  Prof. Dr.  Matthias  Bethge 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie, Sektion Rehabilitation und Arbeit
    • Mr.  Prof. Dr.  Matthias  Bethge 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu Lübeck
    • Mr.  Richard  Albers 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Bund
    • Ms.  Dr.  Ullrike  Worringen 
    • 10704  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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