Ketamine for Phantom Limb Pain
(PLP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests ketamine as a potential treatment for phantom limb pain, a condition affecting many amputees who feel pain in a limb that is no longer there. Researchers aim to determine if ketamine can provide relief when other pain medications have been ineffective. Participants will receive up to 16 ketamine treatments, administered as intramuscular injections, over six months to assess its impact on pain reduction. Individuals currently experiencing phantom limb pain and willing to participate in this year-long study might be suitable candidates. As a Phase 2 and Phase 3 trial, this research measures ketamine's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
You may need to stop or adjust some of your current medications. For example, you should not take certain medications that could interfere with ketamine, like some stimulants, alcohol, and certain CNS depressants, close to your ketamine sessions. It's important to discuss your specific medications with the study team to see what adjustments might be needed.
Is there any evidence suggesting that ketamine is likely to be safe for humans?
Research has shown that ketamine can help manage various types of pain, including phantom limb pain. Some studies found that ketamine reduced severe phantom limb pain when administered during and after surgery. Other research suggests that starting ketamine treatment soon after amputation might alleviate phantom limb pain.
Regarding safety, ketamine is usually well-tolerated in controlled settings. However, concerns exist about the long-term safety of repeated ketamine use. Although limited information is available on its use for long-term pain, researchers continue to study ketamine's safety.
Ketamine has been safely used for other purposes, such as anesthesia, suggesting it could be safe for new treatments like this one. Participants in the study will receive support during sessions to ensure their safety and comfort.12345Why do researchers think this study treatment might be promising for phantom limb pain?
Unlike the standard treatments for phantom limb pain, which often include medications like opioids or antidepressants, ketamine is unique because it targets the brain's NMDA receptors. This different mechanism of action could potentially alter pain perception more effectively. Researchers are excited because ketamine can be administered intramuscularly, allowing for rapid onset of relief within hours or days, whereas traditional treatments can take much longer to show effects. Additionally, ketamine's ability to modulate neural pathways offers hope for more sustainable pain management.
What evidence suggests that ketamine might be an effective treatment for phantom limb pain?
Research has shown that ketamine can help reduce phantom limb pain. In studies, all patients who took ketamine reported feeling less pain, as measured by tools like the Visual Analogue Scale (VAS) and the McGill Pain Questionnaire. These studies suggest that ketamine can increase pain tolerance, making patients less sensitive to pain. For some, ketamine significantly lowers pain levels, making it a promising treatment for this challenging condition. While it may not work for everyone, evidence suggests ketamine could effectively manage phantom limb pain. Participants in this trial will receive ketamine as part of the PLP Ketamine Intervention arm to evaluate its effectiveness in reducing phantom limb pain.36789
Are You a Good Fit for This Trial?
This trial is for individuals with Phantom Limb Pain (PLP), a condition often experienced by amputees. Participants should have a history of significant PLP and be willing to undergo multiple ketamine treatment sessions. The study excludes those who do not meet the minimum remission period of 7 days between treatments or respond inadequately to ketamine.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 16 ketamine sessions over six months, with dosage determined in the initial session and adjusted as needed.
Follow-up
Participants are monitored for safety and effectiveness after treatment using assessment tools like the McGill Pain Questionnaire.
What Are the Treatments Tested in This Trial?
Interventions
- IM Ketamine
Trial Overview
The study tests intramuscular (IM) administration of ketamine in varying doses, aiming to find an effective treatment for PLP. Over six months, each participant will receive up to 16 sessions, with dosage adjustments based on individual response and a maximum limit of 120mg per session.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Ketamine Research Foundation
Lead Sponsor
Citations
Phantom limb pain: a review of pharmacological management
Ketamine resulted in a reduction in pain in all 11 patients (VAS and McGill Pain Questionnaire). Ketamine increased pressure pain thresholds ...
The effect of ketamine on phantom pain
All 11 patients responded with a decrease in the rating of stump and phantom limb pain assessed by visual analogue scale (VAS) and McGill Pain Questionnaire ( ...
How Effective is Ketamine in the Management of Chronic ...
10% of the patients given ketamine exhibited a 50% or greater reduction in pain score after 3 weeks compared with 18% for placebo (Χ2 [3] = 1.1, p = 0.76) [ ...
4.
journals.lww.com
journals.lww.com/pain/abstract/1996/09000/the_effect_of_ketamine_on_phantom_pain__a_central.10.aspxThe effect of ketamine on phantom pain: a central...
All 11 patients responded with a decrease in the rating of stump and phantom limb pain assessed by visual analogue scale (VAS) and McGill Pain Questionnaire ( ...
(402) A retrospective investigation into the impact of early ...
This retrospective observational study tests the hypothesis that intravenous ketamine infusions initiated within 30 days of limb amputation will improve phantom ...
Ketamine for chronic pain: risks and benefits - PMC
Low dose ketamine produces strong analgesia in neuropathic pain states, presumably by inhibition of the N-methyl-D-aspartate receptor.
Prevention of severe phantom limb pain by perioperative ...
This investigation indicates that intra- and postoperative ketamine administration (for 72 h) may prevent severe and clinically relevant phantom limb pain.
Study Details | NCT07276542 | Clinical Trial Exploring the ...
Presence of phantom limb pain at the time of administration of ketamine. Willingness to participate in the study and follow-up over a year long ...
Ketamine for pain management
There is only very limited evidence for the use of ketamine in chronic noncancer pain and concerns and a lack of safety data concerning long-term or repeated ...
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