Phantom Limb Pain Clinical Trial
Official title:
Cryoanalgesia to Treat Phantom Limb Pain Following a Trans-Femoral (Above-Knee) Amputation: A Randomized, Sham-Controlled Pilot Study
When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain. Unfortunately, phantom pain goes away in only 16% of afflicted individuals, and there is currently no reliable definitive treatment. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and spinal cord that actually increase with worsening phantom pain. These abnormal changes may often be corrected by putting local anesthetic-called a "nerve block"-on the injured nerve, effectively keeping any "bad signals" from reaching the brain with a simultaneous resolution of the phantom limb pain. However, when the nerve block resolves after a few hours, the phantom pain returns. But, this demonstrates that the brain abnormalities-and phantom pain-that occur with an amputation are not necessarily fixed, and may be dependent upon the "bad" signals being sent from the injured nerve(s), suggesting that a very long peripheral nerve block-lasting many months rather than hours-may permanently reverse the abnormal changes in the brain, and provide definitive relief from phantom pain. A prolonged nerve block lasting a few months may be provided by freezing the nerve using a process called "cryoneurolysis". The ultimate objective of the proposed research study is to determine if cryoanalgesia is an effective treatment for intractable post-amputation phantom limb pain. The proposed pilot study will include subjects with an existing above-knee amputation who experience intractable daily phantom limb pain. A single ultrasound-guided treatment of cryoneurolysis (or sham block-determined randomly like a flip of a coin) will be applied to the major nerves of the thigh. Although not required, each subject may return 4-6 months later for the alternative treatment (if the first treatment is sham, then the second treatment would be cryoneurolysis) so that all participants have the option of receiving the active treatment. Subjects will be followed for a total of 12 months with data collected by telephone.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 2026 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult patients of at least 18 years of age 2. Trans-femoral traumatic or surgical amputation at least 12 weeks prior to enrollment distal to the hip (femoral head remaining) 3. Experiencing at least moderate phantom limb pain-defined as a 4 or higher on the Numeric Rating Scale (NRS; 0-10, 0= no pain; 10=worst imaginable pain)-at least daily for the previous 2 months 4. willing to avoid both changes to their analgesic regimen as well as elective surgical procedures from 1 month prior to and at least 4 months following the initial cryoneurolysis procedure. Exclusion Criteria: 1. allergy to amide local anesthetics 2. pregnancy 3. incarceration 4. inability to communicate with the investigators 5. morbid obesity (body mass index > 40 kg/m2) 6. possessing any contraindication specific to cryoneurolysis such as a localized infection at the treatment site, cryoglobulinemia, cold urticaria and Reynaud's Syndrome |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Epimed International, Varian Medical Systems |
United States,
Gabriel RA, Finneran JJ 4th, Trescot AM, Ilfeld BM. Ultrasound-Guided Percutaneous Cryoneurolysis for Postoperative Analgesia After Limb Amputation: A Case Series. A A Pract. 2019 Apr 1;12(7):231-234. doi: 10.1213/XAA.0000000000000893. — View Citation
Said ET, Marsh-Armstrong BP, Fischer SJ, Suresh PJ, Swisher MW, Trescot AM, Prologo JD, Abdullah B, Ilfeld BM. Relative Effects of Various Factors on Ice Ball Formation and Ablation Zone Size During Ultrasound-Guided Percutaneous Cryoneurolysis: A Laboratory Investigation to Inform Clinical Practice and Future Research. Pain Ther. 2023 Jun;12(3):771-783. doi: 10.1007/s40122-023-00497-y. Epub 2023 Mar 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average pain intensity change from baseline 1 month post-intervention | The "average" pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. The primary outcome will be the change from baseline in average pain intensity as measured with the numeric rating scale 1 month following the initial intervention. | Baseline and Month 1 | |
Secondary | Average Daily Phantom Pain intensity change from baseline | The "average" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Post-intervention days 1, 7, and Months 2, 3, 4, and 12 | |
Secondary | Worst Daily Phantom Pain intensity change from baseline | The "worst" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Least Daily Phantom Pain intensity change from baseline | The "least" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Current Daily Phantom Pain intensity change from baseline | The "current" phantom pain level measured using the numeric rating scale at the time of the data collection phone call. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | CROSSOVER Average Daily Phantom Pain intensity change from baseline | The "average" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | CROSSOVER Worst Phantom Pain intensity change from baseline | The "worst" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | CROSSOVER Least Phantom Pain intensity change from baseline | The "least" phantom pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | CROSSOVER Current Phantom Pain intensity change from baseline | The "current" phantom pain level measured using the numeric rating scale at the time of the data collection phone call. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | Average Daily Residual Limb Pain intensity change from baseline | The "average" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Worst Daily Residual Limb Pain intensity change from baseline | The "worst" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Least Daily Residual Limb Pain intensity change from baseline | The "least" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Current Residual Limb Pain intensity change from baseline | The "current" residual limb pain level measured using the numeric rating scale at the time of the data collection call. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | CROSSOVER Average Daily Residual Pain intensity change from baseline | The "average" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | CROSSOVER Worst Daily Residual Pain intensity change from baseline | The "worst" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | CROSSOVER Least Daily Residual Pain intensity change from baseline | The "least" residual limb pain level measured using the numeric rating scale for the previous 24 hours. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | CROSSOVER Current Residual Pain intensity change from baseline | The "current" residual limb pain level measured using the numeric rating scale at the time of the data collection phone call. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10=worst imaginable pain. | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | Patient Global Impression of Change, Initial intervention | This measure is a 7-point ordinal scale requiring the subject to rate the current severity of their global situation as it relates to phantom limb pain (as defined by each individual) compared to their baseline. This scale has the words "very much worse" to the left by the number one, and "very much improved" to the right, adjacent to the number seven. The words "no change" are in the middle of the scale above the number four. | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | CROSSOVER Patient Global Impression of Change | This measure is a 7-point ordinal scale requiring the subject to rate the current severity of their global situation as it relates to phantom limb pain (as defined by each individual) compared to their baseline. This scale has the words "very much worse" to the left by the number one, and "very much improved" to the right, adjacent to the number seven. The words "no change" are in the middle of the scale above the number four. | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | Brief Pain Inventory (interference sub scale), initial intervention | The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The brief Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average" and "current" pain levels using a 0-10 numeric rating scale;(2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0=complete relief,10=no relief] and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. This outcome will include the interference subscale. | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | CROSSOVER Brief Pain Inventory (interference sub scale) | The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The brief Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average" and "current" pain levels using a 0-10 numeric rating scale;(2) percentage of relief provided by pain treatments with one question [reported score is the percentage divided by 10 and then subtracted from 10: 0=complete relief,10=no relief] and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0=no interference;10=complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. This outcome will include the interference subscale. | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | Phantom Limb Pain Frequency, initial intervention | Number of occurrences of phantom limb pain experienced in the previous 24 hours | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Phantom Limb Pain Duration, initial intervention | Average duration of each phantom limb pain experienced in the previous 24 hours | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Residual Limb Pain Frequency, initial intervention | Number of occurrences of residual limb pain experienced in the previous 24 hours | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Residual Limb Pain Duration, initial intervention | Average duration of each residual limb pain experienced in the previous 24 hours | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Non-painful phantom sensations Frequency, initial intervention | Number of occurrences of non-painful phantom sensations experienced in the previous 24 hours | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Non-painful phantom sensations Duration, initial intervention | Average duration of non-painful phantom sensations experienced in the previous 24 hours | Post-intervention days 1, 7, and Months 1, 2, 3, 4, and 12 | |
Secondary | Phantom Limb Pain Frequency, CROSSOVER intervention | Number of occurrences of phantom limb pain experienced in the previous 24 hours | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | Residual Limb Pain Frequency, CROSSOVER intervention | Number of occurrences of residual limb pain experienced in the previous 24 hours | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | Phantom Limb Pain Duration, CROSSOVER intervention | Average duration of each phantom limb pain experienced in the previous 24 hours | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | Residual Limb Pain Duration, CROSSOVER intervention | Average duration of each residual limb pain experienced in the previous 24 hours | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | Non-painful phantom sensations Frequency, CROSSOVER intervention | Number of occurrences of non-painful sensations experienced in the previous 24 hours | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 | |
Secondary | Non-painful phantom sensations Duration, CROSSOVER intervention | Average duration of non-painful sensations experienced in the previous 24 hours | Following the CROSSOVER treatment on Days 1 and 7; Months 1, 2, 3, and 4 |
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