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OpenTrials
Enrolling by Invitation

NCT Number: NCT07737912

SpinePal Open Pilot

SpinePal is a self-guided digital intervention developed for patients undergoing spine surgery. The goal of this study is to learn if SpinePal is acceptable to people undergoing spine surgery. The main question it aims to answer are:

* Is the SpinePal platform considered usable and acceptable by people undergoing spine surgery? * Is the SpinePal intervention feasible among people undergoing spine surgery?

Participants will:

* Take a screening questionnaire * Engage with SpinePal for about 2 weeks before surgery and 4 weeks after surgery * Wear a smartwatch * Complete questionnaires about 4 weeks after surgery * Complete a brief virtual interview to share feedback with the study team

Enrolling by Invitation

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Key information

Conditions

Spine Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Geisel School of Medicine

Lebanon, New Hampshire, 03766, United States

About this study

SpinePal will be piloted in a sample of N = 10 patients who are scheduled to undergo lumbar or cervical spine surgery. A pre-surgery enrollment visit will occur via Zoom at least 2 weeks prior to the patient's surgery. Prior to the visit, the participant will complete screening and baseline measures. The research coordinator will then provide instructions for accessing SpinePal, including a unique user ID and password assigned to the participant. During the enrollment visit, participants will also be provided with instructions for completing physiological monitoring via a wrist-worn Garmin Vivosmart 5. The Garmin will be used to passively collect data on physiological arousal (i.e., heart rate variability), physical activity, and sleep throughout the open pilot. To enable collecting this Garmin data, the research coordinator will also assist participants with downloading and logging into a Labfront account on their smartphone.

Participants will be instructed to use SpinePal for 2-4 weeks leading up to surgery, and for at least 1 month after surgery. Participants will receive daily reminders via push notifications delivered to their smartphone. SpinePal will collect background app usage data to assess adherence and track usage of specific tools.

At 1-month postoperative, participants will receive a link to a REDCap survey including the System Usability Scale (SUS) and Client Satisfaction Questionnaire (CSQ-8), which will serve as the primary outcomes in combination with adherence based on app meta-data. Participants will also repeat surveys conducted preoperatively. The participant will then complete a 30-minute semi-structured exit interview with the research coordinator to gather additional feedback on the intervention framework, platform, content, and procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • English-speaking
  • Able and willing to provide informed consent
  • Scheduled for lumbar or cervical fusion surgery at least 2 weeks from the date of enrollment
  • Owns a smartphone with reliable internet and/or data access
  • Willing to engage with SpinePal and physiological monitoring via wrist-worn Garmin

Exclusion criteria

  • Undergoing surgery for infection, malignancy, or trauma
  • Undergoing isolated thoracic fusion
  • Undergoing another major surgery within 3 months
  • Active suicidal ideation and/or severe mental illness (e.g., psychosis)

Treatment and study plan

SpinePal

Device

SpinePal is a web-based app designed to support patients undergoing spine surgery. The app includes tailored pain education, cognitive-behavioral skills, mindfulness and relaxation activities, and guided imagery exercises. SpinePal was developed through an iterative refinement process with patients who previously underwent surgery and experienced persistent pain, impairment, and opioid use.

Primary outcomes

  1. Usability

    Time frame: Enrollment to the end of treatment at 1 month post-surgery

    Usability is measured by participant responses on the System Usability Scale (SUS). The SUS score will range from 0 to 100, where higher scores indicate better usability.

  2. Acceptability

    Time frame: Enrollment to the end of treatment at 1 month post-surgery

    Intervention acceptability is measured by participant responses on the Client Satisfaction Questionnaire-8 (CSQ-8).

  3. Feasibility

    Time frame: Enrollment to 1 month post-surgery

    Feasibility will be assessed via app meta-data. Engagement rates will be quantified based on the frequency and duration of interactions with the application during the clinical trial period.

Sponsors and collaborators

Lead sponsor

Trustees of Dartmouth College

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

User-Centered Development of an App-Based Cognitive-Behavioral Intervention to Reduce Persistent Opioid Use and Opioid Related Problems Following Spine Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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