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Sensor-Based Measurement of Fear Avoidance and Movement Patterns of Healthy Individuals with Mechanically Induced Lower Back Pain during Movement Tasks: Study Protocol for an Experimental Non-Interventional Study

Sensor-Based Measurement of Fear Avoidance and Movement Patterns of Healthy Individuals with Mechanically Induced Lower Back Pain during Movement Tasks: Study Protocol for an Experimental Non-Interventional Study - InterFEARence

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038643
Enrollment
76
Registered
2025-12-15
Start date
2025-06-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanically Induced Primary Lower Back Pain

Interventions

Group 1: Participants will perform standardized movement tasks (Back Performance Scale, Sit-To-Stand-Test) first with and then without wearing a back pain simulator in a crossover design. Group 2: Par

Sponsors

Friedrich-Alexander-Universität Erlangen-Nürnberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Sufficient knowledge of German (native speaker or C2 level) 2) Body mass index (BMI) between = 18 and = 25 (due to the limited size range of the back pain simulator and Xsens suit) 3) Body height = 155 cm (setup requirement for back pain simulator and Xsens suit) 4) Good physical and mental health state (see exclusion criteria)

Exclusion criteria

Exclusion criteria: 1) Chronic back pain 2) Depression (exceed cut-off score for clinically relevant depression symptoms of 22 on the General Depression Scale (Allgemeine Depressionsskala; ADS-L; Hautzinger, 2012) 3) Serious diseases or conditions (e.g. cancer, severe epilepsy, acute psychosis); serious psychological disorders will be screened via the Web Screening Questionnaire for Common Mental Disorders (WSQ; Donkers et al., 2009) 4) Acute infectious diseases (e.g. HIV/AIDS) 5) Current pregnancy 6) Acute herniation (e.g. spinal disc herniation) 7) Acute back pain (ranging on a scale from 0 = no pain to 10 = worst imaginable pain between = 5 and = 10) 8) Acute muscle and/or skeletal pain interfering with daily activities 9) Diseases of the nerve roots and spine injuries 10) Osteoporosis of the spine or back 11) Surgery on or near the spine 12) Diabetes mellitus (back pain simulator requirement, inter alia because of associated skin and soft tissue changes and higher risk of skin infections; e.g. Gkogkolou & Böhm, 2014) References: Hautzinger M. Allgemeine Depressionsskala: ADS; Manual. Hogrefe; 2012. Donker T, van Straten A, Marks IM, Cuijpers P, others. A brief Web-based screening questionnaire for common mental disorders: development and validation. J Med Internet Res. 2009;11(3):e1134. Gkogkolou P, Böhm M. Skin disorders in diabetes mellitus. JDDG J Dtsch Dermatol Ges. 2014;12(10):847–64.

Design outcomes

Primary

MeasureTime frame
Constructs measured: pain, fear of movement, mobility/performance, and stress. Measures: - Pain: VAS (Visual Analogue Scale) for pain intensity (0 = no pain; 10 = extreme pain). - Fear of movement: VAS scale for fear of movement before each task (0 = no fear; 10 = extreme fear). - Mobility/performance: -- task-related ratings of motion impairment: VAS Scale for motion impairment (0 = no impairment; 10 = total impairment) -- lumbar range of motion, lumbar flexion and movement velocity (assessed with inertial measurement unit (IMU)-based motion capture suit Xsens and EmpkinS holographic 6D wireless locating technique and integrated localizable electromyography radio transponders) -- Observer ratings of movement execution: participants’ performance of the movement execution for the six movement tasks will be rated by a trained observer in both conditions. The scale ranges from 0 to 3 with lower ratings showing a better performance. - Stress: -- emotional distress: VAS scale of emotional distress (0 = no emotional distress; 10 = extreme emotional distress) -- SSSQ-G (German version of the Short Stress State Questionnaire; Ringgold et al., 2024) with 24 items on a 5-point Likert scale -- HRV (measured with a wearable electrocardiogram (ECG) sensor (1-channel ECG)). Assessment Time Points SSSQ-G will be collected before the first set of movements tasks, twice in between the two sets of movements tasks, and after the second set of movement tasks (4 times). VAS (pain, fear of movement, task-related ratings of motion impairment and emotional distress) and Observer ratings will be collected after every movement task (12 times). Lumbar range of motion, lumbar flexion and movement velocity as well as HRV will be collected continously during the movement tasks.

Secondary

MeasureTime frame
Constructs measured: fear avoidance, depressivity, emotional pain processing, pain catastrophizing Measures: - TSK-G (modified German version of the Tampa Scale for Kinesiophobia; Houben et al., 2005) with 11 items - ADS-L (General Depressivity Scale; Hautzinger et al., 2012) with 20 items - AEQ (Avoidance Endurance Questionnaire; Hasenbring et al., 2009) with 49 items - FESV (German version of the emotional pain processing questionnaire; Geissner, 1999, 2001) with 38 items - PCS (Pain Catastrophizing Scale; Meyer et al., 2008) with 13 items - PSS (Percieved Stress Scale; Klein et al., 2016) with 10 items Assessment Time Points: TSK-G, ADS-L, AEQ, FESV and PCS will be conducted in the online-questionnaire before the lab appointment.

Countries

Germany

Contacts

Public ContactCornelia Weise

Friedrich-Alexander-Universität Erlangen-Nürnberg

cornelia.weise@fau.de091318520887

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026