An observational study in Chronic Pain, sponsored by Theresa Lii. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Theresa Lii · Observational
This observational study will collect prospectively specified data on patient characteristics and clinically relevant outcomes in patients who receive a ketamine infusion at Stanford Pain Management Center for the treatment of chronic pain, with the goal of identifying treatment responders and relationships between patient characteristics and treatment response.
Ketamine is a type of anesthetic drug which has been used off-label to treat chronic pain. The effectiveness of intravenous ketamine and its duration of effect are not well-understood. There is high variability in response to ketamine, and it remains unclear which patient characteristics are associated with favorable outcomes. This observational study will collect a wide range of patient-reported outcomes via digital surveys: once at baseline before treatment, and up to 7 follow-up surveys for up to 12 months following a single ketamine infusion. Survey data will be supplemented by clinical data obtained from electronic medical records.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 753 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →This is the only study on the registry with Theresa Lii as lead sponsor.
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This study population consists of adults who receive a ketamine infusion for the treatment of any chronic pain condition. All patients who are scheduled for a ketamine infusion through Stanford's Pain Management Center during this study's enrollment period are contacted for screening.
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.
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.
Patients who receive a ketamine infusion for the treatment of chronic pain in the course of usual clinical care
Drug: Ketamine
A multi-day continuous ketamine infusion delivered intravenously at subanesthetic doses in a monitored setting
Also known as: Ketalar
Change from baseline Patient Global Impression of Change (PGIC) in overall status; measured with PGIC Scale
The PGIC Scale is a single-question 7-point Likert scale ranging from "Very much improved" to "Very much worse."
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Change from baseline average pain intensity; measured with Numeric Rating Scale (NRS)
Participants rate their average pain intensity over the last 7 days using whole numbers on a 0-to-10 scale, with higher values indicative of more pain.
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Change from baseline opioid use; measured with 2 questions
Question 1: Participants are asked whether they have used any opioid medications since their last ketamine infusion (yes/no). Question 2: Participants are asked to rate how their opioid use has changed on a 4-point scale ranging from "I have not used any opioids since my last ketamine infusion" to "I am using more opioids after my last ketamine infusion."
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Change from baseline pain catastrophizing score; measured with Pain Catastrophizing Scale - Short Form
Pain Catastrophizing Scale - Short Form is a 4-item scale with a total score ranging from 0-16, with higher scores indicative of more catastrophizing.
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Change from baseline pain interference score; measured with PROMIS Pain Interference
PROMIS Pain Interference is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more pain interference.
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Change from baseline physical function score; measured with PROMIS Physical Function
PROMIS Physical Function is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of better physical function.
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Change from baseline depression score; measured with PROMIS Depression
PROMIS Depression is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more depression.
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Change from baseline anxiety score; measured with PROMIS Anxiety
PROMIS Anxiety is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more anxiety.
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Change from baseline sleep disturbance score; measured with PROMIS Sleep Disturbance
PROMIS Sleep Disturbance is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of more sleep disturbance.
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Change from baseline global health score; measured with PROMIS Global Health
PROMIS Global Health is a computerized adaptive test with results reported as a T-score (mean score of 50 and standard deviation of 10), with higher T-scores indicative of better overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Change from baseline body areas affected by pain; measured with CHOIR Body Map
CHOIR Body Map is a validated self-report body map where participants select areas of the body affected by pain, with a higher number of selected areas indicative of more widespread pain.
Time frame: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, 12 months (or up to the time of their next ketamine infusion)
Plan to share: Yes — Individual participant data that underlie the results reported in the publication, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Analytic code
Time frame: Immediately following publication. No end date.
Access criteria: IPD may be shared upon reasonable request to researchers who provide a methodologically sound proposal.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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