SpinePal Open Pilot

NCT07737912 | Enrolling By Invitation

• 2 other identifiers: STUDY000333965P30DA029926-15
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spine Surgery

Keywords

Spine Surgery; Digital Health; Digital Intervention

Outcome Measures

Primary Outcomes (3)

• Usability

  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

  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

  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

Study Arms (1)

SpinePal

EXPERIMENTAL

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

Interventions

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.

SpinePal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Dartmouth Geisel School of Medicine

Lebanon, New Hampshire, 03766, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)