Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain (NCT07643207)
Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain: A Single-Site Observational Feasibility and Validity Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: BioSensics LLC — Newton, Massachusetts
Age range: 18 Years to 65 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- BioSensics LLC — Newton, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Low Back Pain
- Nonpharmacologic Pain Management in FQHC Primary Care Clinics — Salt Lake City, Utah
- Non-surgical Spinal Decompression Therapy and Outcomes — Stanford, California
- Non-pharmacological Treatment for Pain After Spine Surgery — Honolulu, Hawaii
- TeleYoga for Chronic Low Back Pain: A Quantitative and Qualitative Study — Kansas City, Kansas
- SMART Stepped Care Management for Low Back Pain in the Military Health System — Schofield Barracks, Hawaii
- Intracept Intraosseous Basivertebral Nerve Ablation — Farmington, Utah
Explore by condition: All Low Back Pain clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.