M54
Conditions
Interventions
Group 1: At baseline (T0), participants with chronic low back pain provide data on the following aspects: Occurrence of low back pain according to the time-based criterion of the past 12 weeks, age, g
Wanner et al., 2016), medication intake (Harden et al., 2005), pain intensity and pain disability (CPG, von Korff et al., 1992
Klasen et al., 2004), pain catastrophizing (PCS
Sullivan et al., 1995
Meyer et al., 2008), pain self-efficacy (PSEQ, Nicholas, 2007
FESS, Mangels et al., 2009), avoidance-endurance (AE-FS, Wolff et al., 2018), responses of significant others to pain (WHYMPI, Kerns et al., 1985
Patienten MPI-D Teil 2, Flor et al., 1990), social support (F-SozU K-14
Fydrich et al., 2007), physical activity (leisure): Risk perception (Lippke et al., 2004), outcome expectancies (Meng et al., 2009), intention, self-efficacy, and action planning (Knoll et al., 2017
Sniehotta et al., 2005), self-control (SCS-K-D
Bertrams & Dickhäuser, 2009
Singh, 2022), perceived stress (PSS-10, Cohen et al., 1983
Klein et al., 2016), and back mobility and posture (PAS SBK, Cramer et al., 2018).
On the following 14 days, participants with low back pain wear an activity sensor/accelerometer Move 4 by movisens,
Sponsors
MSB Medical School Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Written inform consent • Individuals with chronic low back pain or asymptomatic individuals aged 18 to 64 years • Pain duration >12 weeks • Pain localization: lumbopelvic region • Indications for surgery: disc degeneration, facet joint arthrosis, spondylolisthesis
Exclusion criteria
Exclusion criteria: • Professional, competitive, and top athletes • Acute infections • Abuse of addictive substances • Pregnancy • BMI >28 kg/m2 • Central or peripheral neurologic impairments (e.g., spinal cord injury, radicular symptoms, sensory deficits) • Irritated, inflamed, and infected tissues in the measuring areas of the back • Spinal fractures • Osteoporosis • Tumor diseases and bone metastases • Previous spinal surgery • Strong drug therapy (opioids, muscle relaxants, antiepileptics) • Intake of long-acting antihistamines and/or systemic glucocorticoids and/or immunosuppressive drugs • Rheumatic diseases • Active systemic diseases (e.g., tuberculosis, collagenosis, multiple sclerosis, autoimmune diseases, acquired immune deficiency syndrome) • Internal diseases that pose a potential risk to the study participants during the measurements (e.g., coronary heart diseases) and/or influence the findings • Malpositions or anomalies of the lower extremities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical activity (leisure), which is the primary outcome, will be assessed at baseline (T0) and follow-up (T2, T3) assessments using self-reports (i.e., IPAQ long, Craig et al., 2003; Wanner et al., 2016), and during the 14-days intensive study period, using accelerometers (i.e., Move 4 activity sensors). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity, which is the secondary outcome, will be assessed at baseline (T0) and follow-ups (T2, T3) using the German version of the Chronic Pain Grade Questionnaire (CPG, von Korff et al., 1992; Klasen et al., 2004). For the ambulatory assessment, pain intensity will be assessed with a single item based on the CPG questionnaire. Subjective health with regard to participants’ lower back (i.e., back health), which is an additional secondary outcome, will be assessed at baseline (T0) and follow-ups (T2, T3) using an adapted item 1 from the Short-Form-Health-Survey-12 (SF-12, Morfeld, Kirchberger, & Bullinger, 2011). For the ambulatory assessment, back health will be assessed with a single item based on the adapted SF-12 item. Additionally, theory-based psychological resources and risk factors as proposed in the Health Action Process Approach (HAPA, Schwarzer, 2008) and the Fear-Avoidance Model (Lethem et al., 1983) will be examined in the context of physical activity. In addition to physical activity, medication intake will be assessed. | — |
Countries
Germany
Contacts
Public ContactKarolina Kolodziejczak
MSB Medical School Berlin
Outcome results
None listed