SpinePal Open Pilot

July 30, 2026 updated by: Madelyn R. Frumkin, Trustees of Dartmouth College

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

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 questions the investigators aim 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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth Geisel School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SpinePal
Participants will have access to SpinePal from 2 weeks before surgery through 4 weeks after surgery. Participants can use SpinePal as much or as little as they want.
Device: SpinePal
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Enrollment to the end of treatment at 1 month post-surgery
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).
Enrollment to the end of treatment at 1 month post-surgery
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.
Enrollment to 1 month post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trustees of Dartmouth College

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 27, 2026

First Submitted That Met QC Criteria

July 27, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

July 31, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00033396
  • 5P30DA029926-15 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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