Clinical trial NCT05985811: Ketamine Enhances Analgesia and Mood in Chronic Pain Patients
Official title: Ketamine Analgesia Enhances Functional Quality and Mood in Chronic Pain Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mood Disorder; Opioid
Mood Insomnia
Keywords: Mood therapy
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult chronic pain clinic patients who have mood disorders; and undergoing routine regular ketamine injections for pain therapy.

Brief summary: Most chronic pain patients have mood disorders. The mood disorders may improve with better analgesia produced by Ketamine injections. A prospective study of patients undergoing interventional pain therapy using Ketamine injections. Pre-injection and post-injection patient data is collected. Pain is measured using numeric pain rating scale, and change in pain score by 2-points is considered significant. Sleep is measured using Likert sleep scale, and change in sleep score by 2-points is considered significant. Anxiety is measured using general anxiety disorder (GAD-7) scale, and change in anxiety score by 4-points is considered significant. Depression is measured using patient health questionnaire (PHQ-9), and change in depression score by 5-points is considered significant.

Detailed description: Chronic pain is usually associated with psychological and mood disorders. Many chronic pain patients have various forms of mood abnormalities; and these mood issues may improve with better analgesia produced by Ketamine injections.

This is a prospective observational study of consenting adult patients who are undergoing interventional pain management. The patients undergo routine interventional pain therapy using Ketamine injections. Pre-injection and post-injection patient data is collected using validated tools. Data collection includes patients' age, psychiatric diagnosis, pain score, sleep score, anxiety score and depression score.

Pain score is measured using the numeric pain rating scale, and a change in the pain score by 2-points is considered significant. Sleep score is measured using the Likert sleep scale, and a change in the sleep score by 2-points is considered significant. Anxiety is measured using the general anxiety disorder (GAD-7) scale, and a change in the anxiety score by 4-points is considered significant. Depression is measured using the patient health questionnaire (PHQ-9) scale, and a change in the depression score by 5-points is considered significant.

Data is analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value \<0.05 is considered significant.

Eligibility criteria: Inclusion Criteria:

* adult chronic pain patients
* associated mood disorder
* good treatment compliance
* associated chronic insomnia
* regular ketamine pain therapy injection
* consent for clinical record quality assurance review

Exclusion Criteria:

* severe cognitive disorder
* inability to provide consent
* major neuropsychiatric disorder
* cannabis use
* stimulant use
* substance abuse
* poor treatment compliance
* lack of ketamine pain therapy injection

Primary outcomes:
measure: Pain score, objective measurement using the validated Numeric Pain Rating scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Sleep quality score, objective measurement using the validated Likert sleep scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Salem Anaesthesia Pain Clinic
state: British Columbia
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olumuyiwa Bamgbade, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: