This is a single-site, prospective, observational, single-visit feasibility and validity study. Adult participants with and without low back or neck pain will be screened, consented, and enrolled to undergo a structured wearable-sensor-based spine assessment in a single on-site visit.
Approximately 20 participants will be enrolled at a single site:
* Approximately 10 adults with self-reported chronic or subacute low back or neck pain (LBP/Neck Pain group)
* Approximately 10 adults without current back or neck pain (Control group)
The AxiSens battery includes the Fingertip-to-Floor (FTF) test for lumbar flexion, the Chin-to-Chest (CTC) test for cervical flexion, a seated Trunk Stability Test on an unstable surface, the Cervical Flexor Endurance Test, the five-times sit-to-stand F5xSTS) test, and a brief functional task module covering overhead and forward reach.
To support intra-rater repeatability characterization, the AxiSens wearable assessment is performed twice within the same visit by a single trained operator, with sensor doffing and re-donning between the two assessments. A short rest interval is provided between the two assessments.
Following the on-site assessment, participants complete a brief end-of-session usability and tolerability questionnaire and the Technology Acceptance Model (TAM) questionnaire.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Male or female, aged 18-65 years
* Fluent in English (able to speak and read)
* Ambulatory without the need for a walking aid
* Able to independently perform all study activities safely, as determined by the investigator
* Willing and able to provide informed consent and comply with all study procedures
For LBP/Neck Pain participants:
* Self-reported low back or neck pain present for at least 4 weeks (subacute or chronic), with current Numeric Pain Rating Scale (NPRS) score of 3 or higher in the past 7 days
* No history of spine surgery within the past 12 months
For Control participants:
• No current low back or neck pain (NPRS \< 2 in the past 30 days) and no history of clinically significant spine condition or spine surgery
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded from the study:
* History of spine fracture, spinal deformity (e.g., scoliosis with Cobb angle \> 25°), or spinal cord injury
* Active radicular signs requiring imaging or specialist referral, as determined by the investigator
* Neurological, vestibular, or musculoskeletal condition that would interfere with safe performance of the study tasks
* Pregnant individuals
* Skin condition or adhesive sensitivity precluding sensor application
* Body mass index (BMI) \< 18 kg/m² or \> 40 kg/m²
* Inability to provide informed consent or comply with study procedures
Primary outcome measure(s)
Group discrimination between control/low back pain/neck pain - Peak lumbar flexion range of motion — Baseline Visit AxiSens system shall discriminate between groups based on peak lumbar flexion range of motion and lumbopelvic coordination ration during the Fingertip to Floor test.
Group discrimination between control/low back pain/neck pain - Peak cervical flexion range of motion — Baseline Visit AxiSens system shall discriminate between groups based on peak cervical flexion range of motion and cervicothoracic coordination ration during the Chin to Chest test.
Group discrimination between control/low back pain/neck pain - Angular variability — Baseline Visit AxiSens system shall discriminate between groups based on angular variability of the sagittal and frontal planes during the Trunk Stability test in eyes open and eyes closed conditions.
Group discrimination between control/low back pain/neck pain - Cervical flexor endurance time — Baseline Visit AxiSens system shall discriminate between groups based on endurance time during the Cervical Flexor Endurance test.
Group discrimination between control/low back pain/neck pain - Five times sit-to-stand completion time — Baseline Visit AxiSens system shall discriminate between groups based on completion time during the five times sit-to-stand test.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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