Complex Regional Pain SyndromePhase 2NCT02094352
Randomized Controlled Trial of Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome
A Phase 2 study testing Ketamine Infusion + Epidural Infusion and Ketamine Booster Infusion in people with Complex Regional Pain Syndrome, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
The purpose of this study is to determine whether epidural and ketamine infusions are effective in the treatment of Complex Regional Pain Syndrome (CRPS). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Complex Regional Pain Syndrome
- What is being tested?
- Ketamine Infusion + Epidural Infusion and Ketamine Booster Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2014to 20 Apr 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must meet the Budapest CRPS criteria, including two or more symptom categories and three or more sign categories (as previously documented by a pain management physician or neurologist, or as observed on initial neurologic examination by the study investigator)
- Patients must have trialed at least three of the following therapies without relief judged adequate by the patient:
- Anti-depressants
- Anti-seizure medication
- Muscle relaxants
- Nerve blocks (somatic or sympathetic)
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- Non-opioid analgesics
- Non-steroidal anti-inflammatory drugs
- Opioid analgesics
- Physical therapy
- Spinal cord stimulator trial
- Patients of either gender between the ages of 18 and 65 inclusive
- Patient report of a NRS pain score of at least 5 in at least two out-patient pain management physician clinic visits
Who cannot join
- Patients younger than 18 or older than 65
- Patients who:
- Are pregnant
- Are affected with glaucoma
- Are affected with thyrotoxicosis
- Are lactating
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- Are on chronic anticoagulation therapy
- Have autonomic dysfunction with hemodynamic instability
- Have cardiac rhythm disturbance
- Have cerebrovascular disease
- Have conditions that would preclude central line placement
- Have conditions that would preclude epidural catheter placement
- Have congestive heart failure
- Have coronary artery disease
- Have creatinine level above 1.5
- Have electrolyte disturbance
- Have had previous reaction to IV contrast dye
- Have history of deep vein thrombosis
- Have history of systemic administration of ketamine for the treatment of pain
- Have liver disease
- Have known history of psychosis, significant thought disorder, or untreated (bipolar disorder depression or anxiety disorder ok)
- Have uncontrolled hypertension
- Any patient who is unable to provide consent due to cognitive difficulties
- Non-English speakers, as some of the instruments are only validated in English
- Patients with active litigation or workers compensation related to CRPS
- Patients with an intolerance or allergy to any medication planned as a component of the study
- Patients with known history of illegal drug use or alcohol dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Randomized Controlled Trial of Subanesthetic Intravenous Ketamine Infusion in Conjunction With Continuous Epidural Infusion for Treatment of Refractory Complex Regional Pain Syndrome
The purpose of this study is to determine whether epidural and ketamine infusions are effective in the treatment of Complex Regional Pain Syndrome (CRPS).
Read the detailed description
Potential patients must clear all study requirements to be enrolled. Study requirements include labwork, psychiatric evaluation, and cardiology evaluation.
Once enrolled, patients will be in one of two groups:
- Receives epidural infusion
- Receives epidural and ketamine infusions
The patient and study staff are blinded.
This study requires multiple visits to Hospital for Special Surgery in New York City over the course of three months and concludes with a final visit after six months. The study will only cover costs associated with the scheduled in-patient and out-patient visits. The study patient will be responsible for all other costs (including travel and hotel accommodations) that he/she may incur for participating in this study.
- Conditions
- Complex Regional Pain Syndrome
- Being tested
- Ketamine Infusion + Epidural Infusion, Control Group + Epidural infusion, Ketamine Booster Infusion, Control Group Booster Infusion
- Keywords
- Complex Regional Pain Syndrome, Pain management, Ketamine infusion
- Medical subject headings
- Complex Regional Pain Syndromes, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Infusion + Epidural InfusionDrug
Also called Ketamine, Epidural
The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
Control Group + Epidural infusionDrug
Also called Epidural
The saline and epidural infusions will be administered over 96 hours with appropriate titration.
Ketamine Booster InfusionDrug
Also called Ketamine
Patients will receive three ketamine booster infusions over the course of three months.
Control Group Booster InfusionDrug
Also called Saline
Patients will receive three saline booster infusions over the course of three months.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Infusion + Epidural Infusion + Booster Infusion | Experimental | Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three ketamine booster infusions over the course of three months. Receives: Drug: Ketamine Infusion + Epidural Infusion; Drug: Ketamine Booster Infusion |
| Control Group + Epidural Infusion + Booster Infusion | Placebo comparator | Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three saline booster infusions over the course of three months. Receives: Drug: Control Group + Epidural infusion; Drug: Control Group Booster Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
Evidence of changes in NRS pain scores between baseline and six months post infusion
Measured: 6 months post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study start24 Mar 2014
- Primary completion20 Apr 2015
- Study completion20 Apr 2015
Why it stopped: The study was unable to enroll efficiently despite trying various technique.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complex Regional Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I Richman, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094352
- Sponsor's protocol ID
- 2013-003
- Status last verified
- Jan 2018
- First submitted
- 23 Dec 2013
- Last updated
- 31 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Subanesthetic Intravenous Ketamine Infusion in Conjunction With Continuous Epidural Infusion for Treatment of Refractory Complex Regional Pain Syndrome
- ClinicalTrials.gov ID
- NCT02094352
- Acronym / sponsor ID
- 2013-003
- Conditions
- Complex Regional Pain Syndrome
- Keywords
- Complex Regional Pain Syndrome, Pain management, Ketamine infusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was unable to enroll efficiently despite trying various technique.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 24 Mar 2014 (actual)
- Primary completion
- 20 Apr 2015 (actual)
- Study completion
- 20 Apr 2015 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether epidural and ketamine infusions are effective in the treatment of Complex Regional Pain Syndrome (CRPS).
Detailed description
Potential patients must clear all study requirements to be enrolled. Study requirements include labwork, psychiatric evaluation, and cardiology evaluation.
Once enrolled, patients will be in one of two groups:
- Receives epidural infusion
- Receives epidural and ketamine infusions
The patient and study staff are blinded.
This study requires multiple visits to Hospital for Special Surgery in New York City over the course of three months and concludes with a final visit after six months. The study will only cover costs associated with the scheduled in-patient and out-patient visits. The study patient will be responsible for all other costs (including travel and hotel accommodations) that he/she may incur for participating in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Infusion + Epidural Infusion + Booster Infusion | Experimental | Drug: Ketamine Infusion + Epidural Infusion, Drug: Ketamine Booster InfusionInpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three ketamine booster infusions over the course of three months. |
| Control Group + Epidural Infusion + Booster Infusion | Placebo comparator | Drug: Control Group + Epidural infusion, Drug: Control Group Booster InfusionInpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion. Outpatient: Patients will receive three saline booster infusions over the course of three months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must meet the Budapest CRPS criteria, including two or more symptom categories and three or more sign categories (as previously documented by a pain management physician or neurologist, or as observed on initial neurologic examination by the study investigator)
- Patients must have trialed at least three of the following therapies without relief judged adequate by the patient:
- Anti-depressants
- Anti-seizure medication
- Muscle relaxants
Key exclusion criteria (27 listed)
- Patients younger than 18 or older than 65
- Patients who:
- Are pregnant
- Are affected with glaucoma
- Are affected with thyrotoxicosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine Infusion + Epidural InfusionAlso: Ketamine, EpiduralThe ketamine and epidural infusions will be administered over 96 hours with appropriate titration. | Drug | Ketamine Infusion + Epidural Infusion + Booster Infusion |
| Control Group + Epidural infusionAlso: EpiduralThe saline and epidural infusions will be administered over 96 hours with appropriate titration. | Drug | Control Group + Epidural Infusion + Booster Infusion |
| Ketamine Booster InfusionAlso: KetaminePatients will receive three ketamine booster infusions over the course of three months. | Drug | Ketamine Infusion + Epidural Infusion + Booster Infusion |
| Control Group Booster InfusionAlso: SalinePatients will receive three saline booster infusions over the course of three months. | Drug | Control Group + Epidural Infusion + Booster Infusion |
Primary outcome
Pain Reduction
Time frame: 6 months post infusion
Evidence of changes in NRS pain scores between baseline and six months post infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hospital for Special SurgeryLink provided by the sponsor.
Related trials for Complex Regional Pain Syndrome
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
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RecruitingPhase 3
Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
Complex Regional Pain Syndrome Type I
Recruiting
The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel I Richman, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine Infusion + Epidural Infusion and Ketamine Booster Infusion in people with Complex Regional Pain Syndrome, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction (time frame: 6 months post infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.