M54
Conditions
Interventions
Group 1: The study consists of a series of micro-randomised single-case studies (n-of-1 studies). Each single-case study comprises two assessment phases. Two groups of participants will be included
the inclusion criteria are chronic low back pain or the absence of chronic pain (regardless of location).
Following a one-week baseline phase, participants enter a 60-day intervention phase. At the en
Sponsors
MSB Medical School Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Work involving a predominantly seated position (e.g. office work) • No chronic pain or chronic low back pain (lasting > 12 weeks) • Sufficient knowledge of German and the ability to understand and work through the questionnaires and instruction materials
Exclusion criteria
Exclusion criteria: • Working less than part-time • Chronic pain in any part of the body, except for low back pain • Participation in professional, competitive or elite sport • Current participation in another study • Acute infection • Current pregnancy • BMI > 29.444 • Postural problems/abnormalities of the lower limbs • Recently operated hip • Tumours, bone metastases • Sensory impairments or neurological disorders • Osteoporosis • Spinal fracture • Inflammation of the spine • Prior spinal surgery • Potent drug therapy (opioids, antiepileptics, muscle relaxants)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable (efficacy) is the number of back exercises performed per day. This is assessed daily over a period of 68 days via self-report using diary-based assessments. For validation purposes, event-based sampling using an accelerometer is additionally implemented, where participants mark the relevant event (i.e., initiation of back exercises) in time by briefly tapping the sensor. The primary outcome variable (feasibility) is the number of days participants remain in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints (efficacy) are recorded daily: Passive, continuous monitoring • Sedentary behaviour (device-based, via Move 4 accelerometer, at work vs. during leisure time; duration of periods spent sitting) • Physical activity (device-based, via Move 4 accelerometer, at work vs. during leisure time) Time-based monitoring (end of day) • Low back pain – pain intensity (self-report, adapted from Von Korff et al., 1992) • Low back health (self-report, adapted from Kolodziejczak-Krupp et al., 2025) • Back movement, posture, mobility, and muscle tension in the lower back (self-report, self-generated items) • Psychological resources and risk factors for engaging in back exercises based on the Health Action Process Approach (Schwarzer, 2008), the Fear-Avoidance Model (Lethem et al., 1983) and the Physical Activity-Mediated Demand-Control (pamDC) Model (Häuser & Mojzisch, 2017). o Habit strength of back exercises (self-report, adapted from Di Maio et al., 2021; Gardner et al., 2012) o Intrinsic reward experience (self-report, adapted from Wiedemann et al., 2014) o Self-efficacy (self-report, adapted from Sniehotta et al., 2005) o Intention (self-report, adapted from Inauen et al., 2016) o Social support (self-report, adapted from Bolger et al., 2023; Scholz et al., 2016) o Action control (self-report, adapted from Berli et al., 2018) o Plan enactment (self-report, adapted from Fleig et al., 2017) o Positive and negative affect (self-report; adapted from Swendsen et al., 2000) o Perceived time pressure and job control (self-report, adapted from Semmer et al., 1999) o Perceived stress (adapted from Cohen et al., 1983; Reichenberger et al., 2021) o Social and physical context The following secondary outcomes (feasibility) are assessed at the end of the study: During the final interview, participants are asked about their experiences with the study (feasibility, acceptability, reactivity) | — |
Countries
Germany
Contacts
Public ContactLena Fleig
MSB Medical School Berlin
Outcome results
None listed