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

NCT07643207 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-06-17

No results posted yet for this study

Summary

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.

Conditions

  • Low Back Pain
  • Neck Pain

Sponsors & Collaborators

  • Ashkan Vaziri

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-12
Primary Completion
2026-07-15
Completion
2026-07-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07643207 on ClinicalTrials.gov