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

NCT07643207 | Not Yet Recruiting

• 1 other identifier: AxiSens-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

wearables; low back pain

Outcome Measures

Primary Outcomes (5)

• Group discrimination between control/low back pain/neck pain - Peak lumbar flexion range of motion

  AxiSens system shall discriminate between groups based on peak lumbar flexion range of motion and lumbopelvic coordination ration during the Fingertip to Floor test.

  Baseline Visit

• Group discrimination between control/low back pain/neck pain - Peak cervical flexion range of motion

  AxiSens system shall discriminate between groups based on peak cervical flexion range of motion and cervicothoracic coordination ration during the Chin to Chest test.

  Baseline Visit

• Group discrimination between control/low back pain/neck pain - Angular variability

  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.

  Baseline Visit

• Group discrimination between control/low back pain/neck pain - Cervical flexor endurance time

  AxiSens system shall discriminate between groups based on endurance time during the Cervical Flexor Endurance test.

  Baseline Visit

• Group discrimination between control/low back pain/neck pain - Five times sit-to-stand completion time

  AxiSens system shall discriminate between groups based on completion time during the five times sit-to-stand test.

  Baseline Visit

Secondary Outcomes (4)

• Numeric Pain Rating Scale

  Baseline Visit

• Neck Disability Index

  Baseline Visit

• Oswestry Disability Index

  Baseline Visit

• Pain, Enjoyment, General Activity (PEG-3)

  Baseline Visit

Study Arms (3)

Control

Adults without low back or neck pain

Low back pain group

Adults with low back pain

Neck Pain

Adults with neck pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy controls, individuals with neck pain, and individuals with low back pain.

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

Sponsors & Collaborators

• Ashkan Vaziri: lead

Study Sites (1)

BioSensics LLC

Newton, Massachusetts, 02458, United States

Location

Related Publications (1)

• Zulbaran-Rojas A, Rouzi MD, Zahiri M, Ouattas A, Walter CM, Nguyen H, Bidadi S, Najafi B, Lemole GM. Objective assessment of postural ergonomics in neurosurgery: integrating wearable technology in the operating room. J Neurosurg Spine. 2024 Apr 19;41(1):135-145. doi: 10.3171/2024.1.SPINE231001. Print 2024 Jul 1.

  PMID: 38626470 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ashkan Vaziri, PhD

CONTACT

888-589-6213; ashkan.vaziri@biosensics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO and Founder

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 11, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

US (1)