An interventional study of SpinePal in Spine Surgery, sponsored by Trustees of Dartmouth College. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Trustees of Dartmouth College · Not applicable, Interventional, and Device feasibility
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:
Participants will:
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.
Trustees of Dartmouth College is the lead sponsor of 38 studies on the registry; 17 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: Enrollment to 1 month post-surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2027, 5 months later.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: start Aug 2026 → Oct 2026, primary completion Dec 2026 → Apr 2027 and completion Dec 2026 → Apr 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Trustees of Dartmouth College