Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain (NCT07643207) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain
United States20 participantsStarted 2026-06-12
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is in the 'NA' phase, which suggests it's more of a measurement and observation study than a treatment trial — does that mean joining it wouldn't change my current care for low back or neck pain at all, and if so, how might it still be useful for me?
2The study is actively enrolling but no longer recruiting, so I can't join right now — but given that it's measuring things like how far I can bend my spine and how long I can hold certain positions, are these kinds of wearable movement assessments something my care team could do for me outside of a trial to help guide my treatment?
3The trial is comparing movement patterns — like lumbar and cervical flexion range of motion and how long I can hold neck muscles active — between people with and without back or neck pain. Based on where I am with my symptoms, would my doctor expect my results on these kinds of tests to look different, and what would that tell us about my condition?
4Since this study seems focused on whether wearable sensors can tell apart people with low back pain, neck pain, and no pain at all, what does my doctor think the practical value of that kind of technology might be for my own diagnosis or monitoring going forward?
5The trial measures a 'five times sit-to-stand' test alongside spine movement — is that kind of functional testing already part of how my doctor evaluates my condition, and should it be, given what I'm dealing with?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Group discrimination between control/low back pain/neck pain - Peak lumbar flexion range of motion
Timeframe: Baseline Visit
2
Group discrimination between control/low back pain/neck pain - Peak cervical flexion range of motion
Timeframe: Baseline Visit
3
Group discrimination between control/low back pain/neck pain - Angular variability
Timeframe: Baseline Visit
4
Group discrimination between control/low back pain/neck pain - Cervical flexor endurance time
Timeframe: Baseline Visit
5
Group discrimination between control/low back pain/neck pain - Five times sit-to-stand completion time