Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain

Part of paid clinical trials in Newton, Massachusetts.

Sponsor
Ashkan Vaziri
Study ID
NCT07643207
Status
Active Not Recruiting

Conditions

  • Low Back Pain
  • Neck Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Study Details

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 Dates

First listed
Jun 11, 2026
Start date
Jun 12, 2026
Status verified
Jun 2026
Primary completion
Jul 15, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Control
    Adults without low back or neck pain
  • Arm: Low back pain group
    Adults with low back pain
  • Arm: Neck Pain
    Adults with neck pain

Primary Outcome Measure

Group discrimination between control/low back pain/neck pain - Peak lumbar flexion range of motion [ Time Frame: Baseline Visit ]

Locations (1)

FacilityCityStateZIPSite coordinators
BioSensics LLCNewtonMassachusetts02458-

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By research site
BioSensics LLC· Newton, MA

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