Spine SurgeryNCT07737912
SpinePal Open Pilot
A study testing SpinePal in people with Spine Surgery, run by Trustees of Dartmouth College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery
- What is being tested?
- SpinePal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dartmouth Geisel School of Medicine
Lebanon, New Hampshire, 03766
About this study
Official title: 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
Read the 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.
- Conditions
- Spine Surgery
- Being tested
- SpinePal
- Keywords
- Spine Surgery, Digital Health, Digital Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpinePalDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SpinePal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Enrollment to 1 month post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start21 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Madelyn R. Frumkin, Trustees of Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737912
- Sponsor's protocol ID
- STUDY00033396
- Other IDs
- 5P30DA029926-15
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User-Centered Development of an App-Based Cognitive-Behavioral Intervention to Reduce Persistent Opioid Use and Opioid Related Problems Following Spine Surgery
- ClinicalTrials.gov ID
- NCT07737912
- Acronym / sponsor ID
- STUDY00033396
- Conditions
- Spine Surgery
- Keywords
- Spine Surgery, Digital Health, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 30 Jul 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.
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
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpinePal | Experimental | Device: SpinePalParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpinePalSpinePal 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. | Device | SpinePal |
Primary outcome
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Spine Surgery
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Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
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Active, not recruiting
High Dose Intensity Modulated Proton Radiation Treatment +/- Surgical Resection of Sarcomas of the Spine, Sacrum and Base of Skull
Chordoma of Spine, Chordoma of Sacrum
Not yet recruiting
A Prospective, Randomized, Two-Arm, Controlled, Single-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of ArtiFix® Dural Repair Sealant Graft in Cranial and Spine Surgery (NEOFIX Study)
CerebroSpinal Fluid (CSF) Leak, Dural Tear
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Recruiting
Evaluation of the Statistical Validity of Cervical Spine Measurements-Including Range of Motion, Strength, and Functional Test Results-for Return to Sport in Patients Who Have Undergone Surgery for Cervical Stenosis and/or Herniation.
Cervical Stenosis, Cervical Spine
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.
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?
A study testing SpinePal in people with Spine Surgery, run by Trustees of Dartmouth College 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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 15 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?
This study is still under way. Results are not available in the source record yet.
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?
Usability (time frame: Enrollment to the end of treatment at 1 month post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.