Low Back PainAxiSens-01NCT07643207
Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain
An observational study of Low Back Pain and Neck Pain, run by Ashkan Vaziri at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Neck Pain
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2026to 30 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy controls, individuals with neck pain, and individuals with low back pain.
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Low Back Pain, Neck Pain
- Keywords
- wearables, low back pain
- Medical subject headings
- Low Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Adults without low back or neck pain | |
| Low back pain group | Adults with low back pain | |
| Neck Pain | Adults with neck pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline Visit
Secondary outcomes (4)
Numeric Pain Rating Scale
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.
Measured: Baseline Visit
Neck Disability Index
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.
Measured: Baseline Visit
Oswestry Disability Index
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.
Measured: Baseline Visit
Pain, Enjoyment, General Activity (PEG-3)
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.
Measured: Baseline Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start12 Jun 2026
- Primary completion1 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ashkan Vaziri
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Ashkan Vaziri, BioSensics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643207
- Sponsor's protocol ID
- AxiSens-01
- Acronym
- AxiSens-01
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38626470
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain: A Single-Site Observational Feasibility and Validity Study
- ClinicalTrials.gov ID
- NCT07643207
- Acronym / sponsor ID
- AxiSens-01 / AxiSens-01
- Conditions
- Low Back Pain, Neck Pain
- Keywords
- wearables, low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ashkan VaziriIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Adults without low back or neck pain |
| Low back pain group | – | –Adults with low back pain |
| Neck Pain | – | –Adults with neck pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy controls, individuals with neck pain, and individuals with low back pain.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Group discrimination between control/low back pain/neck pain - Peak lumbar flexion range of motion
Time frame: 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.
Group discrimination between control/low back pain/neck pain - Peak cervical flexion range of motion
Time frame: 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.
Group discrimination between control/low back pain/neck pain - Angular variability
Time frame: 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.
Group discrimination between control/low back pain/neck pain - Cervical flexor endurance time
Time frame: Baseline Visit
AxiSens system shall discriminate between groups based on endurance time during the Cervical Flexor Endurance test.
Group discrimination between control/low back pain/neck pain - Five times sit-to-stand completion time
Time frame: Baseline Visit
AxiSens system shall discriminate between groups based on completion time during the five times sit-to-stand test.
4 secondary outcomes
Numeric Pain Rating Scale
Time frame: Baseline Visit
Neck Disability Index
Time frame: Baseline Visit
Oswestry Disability Index
Time frame: Baseline Visit
Pain, Enjoyment, General Activity (PEG-3)
Time frame: Baseline Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 38626470Zulbaran-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Neck Pain, run by Ashkan Vaziri at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group discrimination between control/low back pain/neck pain - Peak lumbar flexion range of motion (time frame: Baseline Visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07643207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.