Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain
Running, not enrolling
Conditions studied: Low Back Pain, Neck Pain
In brief
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.
Key facts
- Study ID
- NCT07643207
- Run by
- Ashkan Vaziri
- People needed
- 20
- Starts
- 2026-06-12
- Expected to finish
- 2026-07-30
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- BioSensics LLC — Newton, Massachusetts, United States
Full record on ClinicalTrials.gov
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