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Observational Study of Ketamine Infusions for the Treatment of Chronic Pain

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ClinicalTrials.gov Identifier: NCT05477004
Recruitment Status : Enrolling by invitation
First Posted : July 27, 2022
Last Update Posted : July 27, 2022
Sponsor:
Information provided by (Responsible Party):
Theresa Lii, Stanford University

Tracking Information
First Submitted Date July 21, 2022
First Posted Date July 27, 2022
Last Update Posted Date July 27, 2022
Actual Study Start Date June 1, 2022
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 25, 2022)
Change from baseline Patient Global Impression of Change (PGIC) in overall status; measured with PGIC Scale [ 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) ]
The PGIC Scale is a single-question 7-point Likert scale ranging from "Very much improved" to "Very much worse."
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 25, 2022)
Change from baseline average pain intensity; measured with Numeric Rating Scale (NRS) [ 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) ]
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 25, 2022)
  • Change from baseline opioid use; measured with 2 questions [ 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) ]
    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."
  • Change from baseline pain catastrophizing score; measured with Pain Catastrophizing Scale - Short Form [ 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) ]
    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.
  • Change from baseline pain interference score; measured with PROMIS 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) ]
    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.
  • Change from baseline physical function score; measured with PROMIS 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) ]
    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.
  • Change from baseline depression score; measured with PROMIS 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) ]
    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.
  • Change from baseline anxiety score; measured with PROMIS 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) ]
    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.
  • Change from baseline sleep disturbance score; measured with PROMIS 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) ]
    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.
  • Change from baseline global health score; measured with PROMIS Global Health [ 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) ]
    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.
  • Change from baseline body areas affected by pain; measured with CHOIR Body Map [ 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) ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Observational Study of Ketamine Infusions for the Treatment of Chronic Pain
Official Title Ketamine Infusion for the Treatment Chronic Pain in Adults: a Prospective Observational Study to Characterize Predictors and Outcomes
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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.
Condition Chronic Pain
Intervention Drug: Ketamine
A multi-day continuous ketamine infusion delivered intravenously at subanesthetic doses in a monitored setting
Other Name: Ketalar
Study Groups/Cohorts Open label ketamine
Patients who receive a ketamine infusion for the treatment of chronic pain in the course of usual clinical care
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 25, 2022)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2024
Estimated Primary Completion Date June 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Has been seen at Stanford's Pain Management Center for a doctor's visit at least once.
  • Is scheduled to undergo at least 1 ketamine infusion for the treatment of any chronic pain condition.
  • Have a valid email address and consents to receiving surveys by email.
  • Able to read, understand, and respond to English-language surveys on an electronic device such as a cell phone, tablet, or computer.
  • Able to read, understand, and provide written, dated informed consent.

Exclusion Criteria:

  • Has their ketamine infusion cancelled, which may occur before or after consenting to this study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05477004
Other Study ID Numbers 62561
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in the publication, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Supporting Materials: 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.
Current Responsible Party Theresa Lii, Stanford University
Original Responsible Party Same as current
Current Study Sponsor Theresa Lii
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Theresa Lii, MD Stanford University
PRS Account Stanford University
Verification Date July 2022