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Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain (AxiSens-01)

16 czerwca 2026 zaktualizowane przez: Ashkan Vaziri

Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain: A Single-Site Observational Feasibility and Validity Study

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Szczegółowy opis

Low back and neck pain are among the most common, costly, and disabling musculoskeletal conditions in the United States and worldwide. Low back pain is the leading cause of years lived with disability globally, and neck pain is consistently within the top ten. Both are leading drivers of healthcare expenditure, exceeding spending on diabetes, heart disease, and cancer in some recent analyses. Despite this magnitude, the clinical assessment of spine function remains heavily reliant on subjective self-report and clinician examination, with limited use of objective, quantitative, point-of-care measurement tools.

Wearable sensors, particularly inertial measurement units (IMUs), have matured into a credible technology base for objective musculoskeletal assessment. Multiple research groups have published validation studies establishing the accuracy of IMU-based segmental kinematics against optical motion capture, and feasibility studies demonstrating the utility of wearable kinematics in occupational and clinical settings. Most published wearable-spine assessment work to date has focused on lumbar kinematics in isolation, with cervical kinematic assessment less well-developed and integrated full-spine kinematic assessment relatively rare.

Recent peer-reviewed work demonstrated the feasibility of using wearable IMU technology to objectively assess cervical and upper-back posture in high-risk professional populations during prolonged work tasks. This work established that IMU-based monitoring of upper-body kinematics is feasible in real-world settings and that the methodology generates objective, reproducible data suitable for biofeedback and longitudinal monitoring. The current study extends this established methodology to a broader spine assessment configuration covering cervical, thoracic, lumbar, and pelvic segments, and integrated with validated patient-reported outcome instruments to enable a holistic biopsychosocial assessment of spine function.

The objective of this study is to evaluate the ability of a wearable, multi-modal spine assessment system - AxiSens - to discriminate between adults with low back or neck pain and healthy controls, and to characterize its intra-rater repeatability and workflow feasibility. There is no investigational therapeutic intervention. All participants undergo the same wearable-sensor-based spine assessment procedures in a single on-site visit. Approximately 20 participants will be enrolled, comprising approximately 10 participants in the LBP/Neck Pain group and approximately 10 participants in the Control group.

To support intra-rater repeatability characterization within this single-visit design, the AxiSens wearable assessment is performed twice within the visit by a single trained operator, with sensor doffing and re-donning between the two assessments and a short rest interval. The two within-visit assessments support estimation of the intra-rater repeatability of AxiSens-derived kinematic and composite outcomes.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

20

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Massachusetts
      • Newton, Massachusetts, Stany Zjednoczone, 02458
        • BioSensics LLC

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Control
Adults without low back or neck pain
Low back pain group
Adults with low back pain
Neck Pain
Adults with neck pain

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Group discrimination between control/low back pain/neck pain - Peak lumbar flexion range of motion
Ramy czasowe: Baseline Visit
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
Ramy czasowe: Baseline Visit
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
Ramy czasowe: Baseline Visit
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
Ramy czasowe: Baseline Visit
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
Ramy czasowe: Baseline Visit
AxiSens system shall discriminate between groups based on completion time during the five times sit-to-stand test.
Baseline Visit

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Numeric Pain Rating Scale
Ramy czasowe: Baseline Visit
The Numeric Pain Rating Scale (NPRS) is an 11-point, self-reported assessment tool where 0 means "no pain" and 10 represents the "worst pain imaginable." It is scored simply by recording the whole number indicated by the patient, usually evaluated for current, average, or worst pain levels.
Baseline Visit
Neck Disability Index
Ramy czasowe: Baseline Visit
The Neck Disability Index (NDI) is a 10-question survey that measures how neck pain affects activities of daily life. Each section is scored from 0 to 5, where 5 is a worst outcome. The total is calculated as a percentage to determine the level of functional disability.
Baseline Visit
Oswestry Disability Index
Ramy czasowe: Baseline Visit

The Oswestry Disability Index (ODI) is the gold standard patient-reported questionnaire used to quantify functional disability in individuals with low back pain. It evaluates 10 everyday activities, such as personal care, lifting, walking, and sleeping.

Each of the 10 sections is rated on a 6-point scale from 0 to 5, where 0 indicates no disability and 5 represents the most severe disability.
Baseline Visit
Pain, Enjoyment, General Activity (PEG-3)
Ramy czasowe: Baseline Visit
The PEG-3 is used to assess chronic pain. Patients rate their pain, enjoyment of life, and general activity on a scale of 0 to 10 based on the past week. A higher score indicates a worst outcome.
Baseline Visit

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ashkan Vaziri

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

12 czerwca 2026

Zakończenie podstawowe (Szacowany)

15 lipca 2026

Ukończenie studiów (Szacowany)

30 lipca 2026

Daty rejestracji na studia

Pierwszy przesłany

5 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

11 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • AxiSens-01

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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