An interventional study of cryoablation in Phantom Limb Pain, Stump Neuralgia and Pain, Phantom, sponsored by Military Institute od Medicine National Research Institute. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-25.
Sponsored by Military Institute od Medicine National Research Institute · Not applicable, Interventional, and Treatment
Assessment of pain intensity on the NRS. Assessment of the quality of life by SF-36 and AIS. Diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound control with confirmation of the correct position of the needle using a peripheral nerve stimulator.
Reassessment of pain intensity on the NRS 30 minutes after local anesthetic block.
Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.
If pain intensity on the NRS reduced by less than 2 points, reassessment 60 minutes after local anesthetic block.
Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.
If pain intensity on the NRS reduces by less than 2 points 60 minutes after local anesthetic block cryoablation will not be performed.
Cryoablation effect will be evaluated 24 hours, 7 days, 30 days, 3 months, 6 months post procedure.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's planned enrollment of 50 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Military Institute od Medicine National Research Institute is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
peripheral nerve cryoablation
Procedure: cryoablation
cryoablation of nerve responsible for phantom limb pain
Reduction of pain
Assessment of pain intensity pre- and post - cryoablation on the NRS (numeric rating scale). Numeric Rating Scale (NRS) is a unidimensional measure of pain intensity in adults. This is a 11-point numeric scale ranges from '0' (minimum, "no pain") to '10' (maximum, "pain as bad as one can imagine"). The lower the NRS value, the better clinical outcome.
Time frame: T1: before cryoablation; T2: 24 hours after cryoablation; T3: 7 days after cryoablation; T4: 30 days after cryoablation; T5: 3 months after cryoablation; T6: 6 months after cryoablation.
The quality of life (SF-36)
Assessment of the quality of life pre- and post - cryoablation on SF-36. 36-Item Short Form Survey (SF-36) is a 36-item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. For each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning).
Time frame: A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.
The quality of life (AIS)
Assessment of the quality of life pre- and post - cryoablation on AIS. The Acceptance of Illness Scale (AIS) consists of eight statements describing negative impact of poor health status and its consequences for patients' functioning. The scoring for each statement varies from 1 (poor adaptation to the disease) to 5 (full acceptance of the disease). The total score ranges between 8 and 40. The lower score, the poorer acceptance of disease and more severe restrictions caused by condition. A high score means acceptance of patient's own health status and lack of negative emotions related to illness.
Time frame: A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.
Started Feb 2018 (actual). Primary completion is estimated for Jun 2019, 16 months after the start.
Of 61 non-industry interventional studies with no phase under Phantom Limb, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 16 months is below that.
Counting every sponsor, half of 64 studies reached it within 34 months; a quarter within 13 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Military Institute od Medicine National Research Institute