Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia

March 31, 2025 updated by: Wilderman Medical Clinic

A Two-part Study to Access the Safety and Efficacy of Ketamine Intravenous Infusions in the Treatment of Fibromyalgia

Previous studies of intravenous ketamine, which is a non-competitive N-methyl-D aspartate receptor antagonist, for fibromyalgia pain relief are limited to three studies. Two studies have focused on short-term pain relief of intravenous ketamine by measuring the patients' pain levels immediately before and after the infusion. Currently, existing studies used short-term infusions (30-40 minutes) of sub-anesthetic doses of ketamine for pain relief in fibromyalgia patients, whereas the Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists recommend infusing IV ketamine for at least two hours and a minimal total dose of 80 mg.

The rationale of this study is to expand on the existing data of safety and efficacy of intravenous ketamine to relieve fibromyalgia pain. Specifically, this investigation will add data to fill the existing gap regarding the short- and long-term pain relief in the treatment of fibromyalgia with intravenous ketamine infusions. The study will also attempt to determine safety and tolerability. In addition, the characteristics of treatment responders versus non-responders will be assessed in an effort to determine whether specific characteristics can be used to predict treatment response in this group of patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study consists of two parts. The first part is a single-centre, retrospective chart review to analyze and summarize the investigators' experience with intravenous ketamine infusions in the treatment of patients with fibromyalgia who received at least four infusions for pain management. For the second part, patients who already received at least three intravenous ketamine infusions (for optimal dose determination) will be enrolled in an open single-group prospective study to receive one intravenous ketamine treatment. In this prospective study, the investigators will evaluate infusion effectiveness, safety, and tolerability as well as the influence of patients' demographic and medical characteristics, including depression status and ketamine dissociation symptoms, on the treatment outcome.

This two-part study aims to evaluate whether intravenous ketamine is effective in reducing pain in patients diagnosed with fibromyalgia. To achieve this goal, the study will assess the effect of intravenous ketamine infusions on short- and long-term pain relief. The study will also evaluate the safety and tolerability of ketamine infusions in fibromyalgia patients and factors that may have an impact on the treatment outcome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Thornhill, Ontario, Canada, L4J 1W3
        • Wilderman Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from Wilderman Medical Clinic, a chronic pain clinic located in Thornhill, Ontario. The clinic consists of state-of-the-art out-patient facilities, an interdisciplinary team and nursing support.

Description

Inclusion criteria:

To be included in Part 1 of the study, patients must fulfil the following criteria:

  • Given written consent to permit Wilderman Medical Clinic investigators to use their medical and demographic information in research studies.
  • Male or female >18 years of age
  • Having been diagnosed with fibromyalgia
  • Received at least 4 IV ketamine infusion(s)
  • Made at least one rating of pain (NRS) immediately before the intervention and one after the intervention
  • Had follow-up data recorded on the follow-up visit: percentage and duration of pain relief

To be included in Part 2 of the study, patients must fulfil the following criteria:

  • Male or female >18 years of age
  • Given the written Informed Consent Form to participate in the study
  • Having been diagnosed with fibromyalgia
  • Having been prescribed IV ketamine infusions treatment
  • Passed safety screening for ketamine infusions
  • Had at least 3 IV ketamine infusions for dose optimization
  • Willingness and ability to comply with the study procedure and the ability to follow verbal and written instructions

Exclusion Criteria:

Patients will be excluded from Part 1 of the study if they meet any of the following criteria:

  • Age less than 18 years old
  • Absence of signed Informed Consent Form
  • Patients who received less than 4 IV ketamine infusion(s)
  • Insufficient information to conduct analysis (e.g. absence of pain ratings or follow up measurements)

Patients will be excluded from the Part II of the study if they meet any of the following criteria:

  • Age less than 18 years old
  • Absence of signed Informed Consent Form
  • Received less than 3 IV ketamine infusions
  • Have any contradictions to the administration of intravenous ketamine (known allergy to ketamine or fail to pass Ketamine treatment screening)
  • Diagnosis of dementia or other cognitive impairments
  • Any clinically significant acute or chronic medical condition that in the judgment of Investigator may preclude the use of intravenous ketamine or compromise patient safety, limit patient's ability to complete the study, and/or compromise the objectives of the study.
  • Participation in any other clinical study within 3 months prior to screening and during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Prospective Study Group

A total of approximately 30 patients diagnosed with fibromyalgia will be selected for participation in the study, all of whom will be treated with one IV ketamine infusion for pain relief according to their regular schedule of IV ketamine infusions.

Each patient will be evaluated at baseline (prior to ketamine infusion), 40 minutes post-infusion, and at follow up visits.
Drug: Intravenous Ketamine Infusions
Ketamine will be slowly infused with the routine target dose 1.5-2 mg/kg over 3-4 hours.
Retrospective Study group

A total of approximately 20 patients will be selected for participation in the study, all of whom were treated with IV ketamine infusions. Information regarding clinically relevant outcomes will be obtained from chart reviews from patients who meet the eligibility criteria.

The patient's response to treatment will be assessed.
Drug: Intravenous Ketamine Infusions
Ketamine will be slowly infused with the routine target dose 1.5-2 mg/kg over 3-4 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS)
Time Frame: Baseline visit: immediately before IV ketamine infusion
The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).
Baseline visit: immediately before IV ketamine infusion
Numeric Rating Scale (NRS)
Time Frame: Baseline visit: immediately after the IV ketamine infusion
The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).
Baseline visit: immediately after the IV ketamine infusion
Numeric Rating Scale (NRS)
Time Frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
The NRS is a standardized, one-dimensional measure of pain intensity. The pain intensity is rated by the participant using a scale from 0-10; 0 being the least (no pain) to 10 (worst pain imaginable).
Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Integral of pain relief
Time Frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
IPR is a multidimensional measure combining the duration of patients' pain relief (in days) and the percentage of pain relief that they had experienced. IPR seeks to tap into a fuller picture of the patients' pain relief, since it not only measures current pain levels, but patients' experience of pain, both in duration and percentage of relief, over a longer period of time. The scale has no restrictions, beginning at 0 (no treatment effect). Therefore, the higher the IPR value, the more effective the treatment was at reducing pain
Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Clinician-Administered Dissociative States Scale (CADSS)
Time Frame: Baseline visit: immediately before IV ketamine infusion
The CADSS is a 27-item scale with 19 subject-rated items and 8 items scored by an observer. The subjective component consists of 19 items which are administered by a clinician who begins each question with the phrase "at this time" and then reads the item to the subject. The subject then endorses one of a range of possible responses: 0 = not at all, 1 = slightly, 2 = moderately, 3 = considerably, 4 = extremely. The subject's response on these 0 to 4 scales is recorded and the clinician moves on to the next item. Three non-empirically derived subscales for the CADSS have been proposed: amnesia (two items), depersonalization (five items), and derealization (12 items).
Baseline visit: immediately before IV ketamine infusion
The Clinician-Administered Dissociative States Scale (CADSS)
Time Frame: Baseline visit: 40 minutes after the IV ketamine infusion
The CADSS is a 27-item scale with 19 subject-rated items and 8 items scored by an observer. The subjective component consists of 19 items which are administered by a clinician who begins each question with the phrase "at this time" and then reads the item to the subject. The subject then endorses one of a range of possible responses: 0 = not at all, 1 = slightly, 2 = moderately, 3 = considerably, 4 = extremely. The subject's response on these 0 to 4 scales is recorded and the clinician moves on to the next item. Three non-empirically derived subscales for the CADSS have been proposed: amnesia (two items), depersonalization (five items), and derealization (12 items).
Baseline visit: 40 minutes after the IV ketamine infusion
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline visit: before IV ketamine infusion
PHQ-9 is endorsed by the National Institute for Health and Clinical Excellence for use in primary care in measuring baseline depression severity and responsiveness to treatment. The 9 items on the PHQ-9 consist of the 9 criteria on which the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) depressive disorder diagnoses are based. A 4-point scale indicates a degree of severity; items are rated from 0 (not at all) to 3 (nearly every day).
Baseline visit: before IV ketamine infusion
Patient Health Questionnaire (PHQ-9)
Time Frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
PHQ-9 is endorsed by the National Institute for Health and Clinical Excellence for use in primary care in measuring baseline depression severity and responsiveness to treatment. The 9 items on the PHQ-9 consist of the 9 criteria on which the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) depressive disorder diagnoses are based. A 4-point scale indicates a degree of severity; items are rated from 0 (not at all) to 3 (nearly every day).
Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Time Frame: Baseline visit: before IV ketamine infusion
The LANSS is a simple and valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). S-LANSS is a modified version of the LANSS pain scale to make it capable of self-completion.
Baseline visit: before IV ketamine infusion
Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Time Frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
The LANSS is a simple and valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). S-LANSS is a modified version of the LANSS pain scale to make it capable of self-completion.
Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Fibromyalgia Impact Questionnaire, Revised (FIQR)
Time Frame: Baseline visit: before IV ketamine infusion
The Fibromyalgia Impact Questionnaire (FIQ) is a commonly used instrument in the evaluation of fibromyalgia patients. The revised FIQ has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. All questions are framed in the context of the past 7 days. The FIQR is divided into three linked sets of domains: (a) 'function' (contains 9 questions), (b) 'overall impact' (contains 2 questions), and (c) 'symptoms' (contains 10 questions). The FIQR is an updated version of the FIQ that has good psychometric properties, can be completed in less than 2 minutes and is easy to score.
Baseline visit: before IV ketamine infusion
Fibromyalgia Impact Questionnaire, Revised (FIQR)
Time Frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
The Fibromyalgia Impact Questionnaire (FIQ) is a commonly used instrument in the evaluation of fibromyalgia patients. The revised FIQ has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. All questions are framed in the context of the past 7 days. The FIQR is divided into three linked sets of domains: (a) 'function' (contains 9 questions), (b) 'overall impact' (contains 2 questions), and (c) 'symptoms' (contains 10 questions). The FIQR is an updated version of the FIQ that has good psychometric properties, can be completed in less than 2 minutes and is easy to score.
Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Patients Global Impression of Change (PGIC)
Time Frame: Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
PGIC is a seven-point single-item scale ranging from 'very much worse' to 'very much improved' worse' with 'no change' as the mid-point that evaluates improvement with treatment during a clinical trial.
Follow-up visits at 1, 2, 3, and 4 weeks after the IV ketamine infusion
Periprocedural adverse effects
Time Frame: Baseline visit: During the infusion
Variations of heart rate (beats per minute)
Baseline visit: During the infusion
Periprocedural adverse effects
Time Frame: Baseline visit: During the infusion
Variations of blood pressure (mmHg)
Baseline visit: During the infusion
Periprocedural adverse effects
Time Frame: Baseline visit: During the infusion
Variations of pulse oxygen saturation (percentage of hemoglobin carrying oxygen)
Baseline visit: During the infusion
Periprocedural adverse effects
Time Frame: Baseline visit: During the infusion
Presence of dizziness, nausea, chest pain, shortness of breast
Baseline visit: During the infusion
Postprocedural adverse effects
Time Frame: Baseline visit: During 60-90 minutes after the procedure
Variations of heart rate (beats per minute)
Baseline visit: During 60-90 minutes after the procedure
Postprocedural adverse effects
Time Frame: Baseline visit: During 60-90 minutes after the procedure
Variations of blood pressure (mmHg)
Baseline visit: During 60-90 minutes after the procedure
Postprocedural adverse effects
Time Frame: Baseline visit: During 60-90 minutes after the procedure
Variations of pulse oxygen saturation (percentage of hemoglobin carrying oxygen)
Baseline visit: During 60-90 minutes after the procedure
Postprocedural adverse effects
Time Frame: Baseline visit: During 60-90 minutes after the procedure
Presence of dizziness, nausea, chest pain, shortness of breast
Baseline visit: During 60-90 minutes after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wilderman Medical Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Igor Wilderman, MD, Wilderman Medical Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WMC003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be available according to reasonable demands.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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