Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Smartwatches and rings may help predict pain relief from spinal implants

NCT ID NCT05659836

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether wearable devices like the Apple Watch and Oura Ring, along with digital surveys, can predict outcomes for chronic pain patients receiving spinal cord stimulation. Twenty-eight adults with long-term pain were implanted with Abbott's spinal cord stimulators and used the wearables to track their progress. The goal was to see if objective data from these devices could match or predict how patients report their pain and how their treatment settings are adjusted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Abbott Spinal Cord Stimulation (SCS) Systems with Apple Watch and Oura Ring
What this could lead to
If successful, this could help doctors better predict which chronic pain patients will benefit from spinal cord stimulation, improving treatment decisions.
What could go wrong
This is a small, early feasibility study with only 28 participants, so results may not apply to everyone. It focuses on data collection, not on proving the treatment works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

28 people

The number who actually took part.

Started

May 2021

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients at Chronic Pain Specialty Clinics

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject must provide written informed consent prior to any clinical investigation-related procedure. 2. Subject is at least 18 years of age or older at the time of enrollment. 3. Subject is scheduled to undergo trial of an Abbott neuromodulation system for chronic intractable pain at least 7 days after enrollment and commencement of the baseline data collection period. 4. Subject's scheduled trial duration for the Abbott neuromodulation system is at least 3 days. 5. Subject has a baseline (with no stimulation) pain NRS of ≥ 6. 6. Subject is willing to cooperate with the study requirements including completion of all office visits. 7. Subject agrees to wear the wearable sensing devices (Anne™ patch, Anne™ limb unit, Apple watch®, and Oura™ Ring). 8. Subject agrees to answer questionnaires regularly for the duration of the study. Exclusion Criteria: 1. Subject is enrolled, or intends to participate, in a competing or confounding clinical study, as determined by Abbott. 2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. 3. Subject is part of a vulnerable population. 4. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results. 5. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus. 6. Subject has, or is scheduled to receive, implantation of another neuromodulation system (e.g. DRG or SCS system or intrathecal pump) to address their chronic pain. 7. Subject has already participated in a SCS trial period before enrolling in the study. 8. Subject engages in a profession or other activity that could be damaging to the wearable sensors, as determined by the investigator. 9. Subject has a skin condition that could be exacerbated by use of the adhesive Anne™ sensor or the other wearables (e.g. skin allergy to adhesives, metals, plastics, hydrogels), as determined by the investigator. 10. Subject has a physical condition that makes it difficult to wear the wearable sensors, as determined by the investigator. 11. Subject has tremors (e.g. Parkinson's disease or Familial tremors). 12. Subject has sleep/wake schedule that would present a challenge in completing all clinical site visits or in use of the wearable devices and engagement in the surveys via the mobile device. 13. Subject is bedridden. 14. Subject has evidence of an active disruptive psychological or psychiatric disorder or social condition as determined by the investigator. 15. Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator. 16. Subject is immunocompromised. 17. Subject has history of cancer requiring active treatment in the last 12 months. 18. Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection. 19. Subject has life expectancy of less than 6 months. 20. Subject is involved in an injury claim under current litigation.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic pain are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Coastal Pain & Spinal Diagnostics

    Carlsbad, California, 92009, United States

  • Expert Pain

    Houston, Texas, 77079, United States

  • Goodman Campbell Brain & Spine

    Carmel, Indiana, 46032, United States

  • Pacific Research Institute

    Santa Rosa, California, 95403, United States

  • St. Louis Pain Consultants

    Chesterfield, Missouri, 63017, United States

  • The Orthopedic Institute

    Gainesville, Florida, 32607, United States

  • iSpine Clinics

    Burnsville, Minnesota, 55337, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.