Lower Limb Amputation Above KneeAMPUPHANTOMNCT03789435
Pain in Trans Femoral and Trans Tibial Amputees
An observational study of Lower Limb Amputation Above Knee and Lower Limb Amputation Below Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the perioperative phase correlates with good pain control in the immediate post-operative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
- What is being tested?
- Questionnaire
- How many people
- 73 participants
- Where
- 1 siteItaly
- Study dates
- 7 Mar 2019to 30 Sep 2019
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients amputated above and below the knee at the Orthopedic Divisions of the Rizzoli Orthopedic Institute
Who may be able to join
- Patients undergoing trans-tibial and trans-femoral amputation of any etiology at the Rizzoli Orthopedic Institute from 2015 to 2017
- Presence of analgesia data for surgery in a computerized record (SIR, Rizzoli information system)
- Patients who have accepted to join the study
Who cannot join
- Patients with a medical record inaccessible via SIR (not yet digitized)
- Deceased patients
- Patients under the age of 18
- Non-ambulatory patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medium-term Incidence Study of Phantom Limb Syndrome in Trans Femoral and Trans Tibial Amputated Patients
Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the perioperative phase correlates with good pain control in the immediate post-operative, expressed in terms of reduced demand for opiates by the patient undergoing amputation. of lower limb. Few are studies that highlight the effectiveness of such treatments in the medium and long-term prevention of phantom limb syndrome.
The study aims to evaluate the incidence in the medium term of the phantom limb in trans femoral and trans tibial amputees and the possible relationship with the use of adequate pre and perioperative analgesia using peridural and peripheral nerve catheters. The results of the study could provide indications about the need to modify both the perioperative analgesic therapy protocol and also rehabilitation for lower limb amputation surgery in order to reduce the prevalence of phantom limb syndrome with consequent improvement in quality of life.
Read the detailed description
The prevalence of phantom limb varies from 50-90% in amputated patients. When present, it is difficult to manage and has a significant impact on the patient's quality of life. The causes that determine the development and above all the persistence of this remote syndrome are not known, however some studies report the importance of psychological factors, also related to the time of use of the prosthesis.
After an amputation it is possible to have different pictures of residual pain that are classified as:
- Stump pain (residual limb pain -RLP): described as burning, shock, cut, hypersensitivity of the stump (post-surgical nociceptive, neurogenic, protesigenic, arthrogenic, ischemic, sympathetic, from adhesive scar tissue or hetero topical ossifications, has a incidence of 74% and may persist up to 14 years after amputation.
- Phantom limb pain (PLP) pain: described as a similar neuropathic (cutting, traction, shock pain) and as a similar nociceptive (deaf, cramp-like, compressive), is present in the first 6 months after amputation, but can last for years, and affects up to 85% of patients.
- Phantom limb sensations (phantom sensations - PSs): non-painful perceptions from the part of the body lost after deafferentation or amputation (kinetic, kinesthetic and exteroceptive), is common in the postoperative period, in one third of patients within 24 hours , in three quarters of patients within 4 days, and in 90% of patients, persist within 6 months of surgery.
At present, the scientific evidence shows that the infusion of local anesthetics with perioperative epidural and perineural catheters correlates with good pain control in the immediate post-operative period expressed in terms of reduced opiate demand by of the patient undergoing limb amputation. However, there are no studies on the medium to long-term incidence of phantom limb syndrome in patients who have been treated with multimodal analgesic protocols. Only the observational study performed by Borghi et al. showed that a 3% incidence of phantom limb syndrome in patients treated with prolonged infusion for an average of 30 days with a 0.5% ropivacaine perineural catheter was shown 12 months after limb amputation surgery. Based on this experience for years at the Rizzoli Orthopedic Institute, peridural and peripheral catheters are applied with a dedicated protocol. At present, however, there is no further assessment of the incidence of phantom limb in patients amputated to the IOR who have followed the protocols in use.
Aim The study aims to evaluate the incidence of phantom pain in the medium term, the sensation of phantom limb and the pain of the stump in amputated trans femoral and trans tibial patients operated on the IOR who followed the perioperative analgesic protocol with use of catheters peridural and peripheral nerves. The results of the study could provide indications about the need to modify the perioperative and rehabilitative analgesic therapy protocol for lower limb amputation surgery to favor a reduction in the intensity, prevalence and frequency of phantom limb syndrome with consequent improvement in the quality of life.
Methods Administration (post delivery and supervised compilation by telephone) of the Prosthetic Evaluation Questionnaire (PEQ), of the Houghton Scale of Prosthetic Use in People with Lower-Extremity Amputations and collection of general information : presence and severity of the stump pain, phantom limb pain and phantom limb sensation, weight, height, type of prosthesis and time of use, specific rehabilitation for phantom limb, pharmacological therapy in place.
Type of anesthesia used during surgery and general and local analgesic therapy (perinervous or peridural catheters) used will be retrieved from clinical folders.
Timetable Month 1
- Request to the Institute Informatic System of the identification of patient records with amputation above or below the knee in the years 2015-2017
- Search for computerized folders and data collection of anesthesia and analgesia in a database Month 2
- Identification of patients eligible for the study with consultation of the registry for the search for the deceased
- Sending patient questionnaires and phone calls for completion Month 3
- Collection of questionnaires
- Completion of the database
- Statistic analysis
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireDiagnostic test
A questionnaire from which the session dedicated to the evaluation of the stump pain, the phantom limb and the sensation of the phantom limb has been extracted will be administered: this is the Prosthetic Evaluation Questionnaire (PEQ) validated in Italian by Ferrero et al. 2005.
In the questionnaire sent to patients will be asked also for anthropometric data (weight, height) in addition to the characteristics of the worn prosthesis and if they have followed a period of rehabilitation.The time of use of the prosthesis will be evaluated through the Houghton Scale of Prosthetic Use in People with Lower- Extremity Amputations (19)
| Study group | Role | What they receive |
|---|---|---|
| Amputees | Patients underwent trans-tibial and trans-femoral amputation of any etiology at the Rizzoli Orthopedic Institute from 2015 to 2017 with the presence of analgesia data for surgery in a computerized record (SIR, Rizzoli information system). A questionnaire for the detection of residual limb pain will be administrate to all the survivors. Receives: Diagnostic Test: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid-term incidence (1 to 3 years) of pain in the stump or phantom limb and phantom limb sensation in amputated trans femoral and trans tibial patients treated at IOR from 2015 to 2017.
Data will be obtained by means of questionnaire sent to patients.
Measured: 7 days
Evaluation of the type of anesthesia and perioperative analgesic treatment with peripheral nerve block effected and of the use of the prosthesis to evaluate possible relations with the presence and the entity of the phantom limb.
Anesthesia data will be retrieved from patient records.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start7 Mar 2019
- Primary completion31 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Above KneeStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 73 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- I.R.C.C.S. Fondazione Santa Lucia
- Responsible party
- Principal investigator, Mariagrazia Benedetti, Istituto Ortopedico Rizzoli
- Investigators
- Maria Grazia Benedetti, Principal investigator, IRCCS-Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789435
- Sponsor's protocol ID
- 0013569
- Acronym
- AMPUPHANTOM
- Status last verified
- Jan 2020
- First submitted
- 27 Dec 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium-term Incidence Study of Phantom Limb Syndrome in Trans Femoral and Trans Tibial Amputated Patients
- ClinicalTrials.gov ID
- NCT03789435
- Acronym / sponsor ID
- AMPUPHANTOM / 0013569
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- I.R.C.C.S. Fondazione Santa Lucia
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the perioperative phase correlates with good pain control in the immediate post-operative, expressed in terms of reduced demand for opiates by the patient undergoing amputation. of lower limb. Few are studies that highlight the effectiveness of such treatments in the medium and long-term prevention of phantom limb syndrome.
The study aims to evaluate the incidence in the medium term of the phantom limb in trans femoral and trans tibial amputees and the possible relationship with the use of adequate pre and perioperative analgesia using peridural and peripheral nerve catheters. The results of the study could provide indications about the need to modify both the perioperative analgesic therapy protocol and also rehabilitation for lower limb amputation surgery in order to reduce the prevalence of phantom limb syndrome with consequent improvement in quality of life.
Detailed description
The prevalence of phantom limb varies from 50-90% in amputated patients. When present, it is difficult to manage and has a significant impact on the patient's quality of life. The causes that determine the development and above all the persistence of this remote syndrome are not known, however some studies report the importance of psychological factors, also related to the time of use of the prosthesis.
After an amputation it is possible to have different pictures of residual pain that are classified as:
- Stump pain (residual limb pain -RLP): described as burning, shock, cut, hypersensitivity of the stump (post-surgical nociceptive, neurogenic, protesigenic, arthrogenic, ischemic, sympathetic, from adhesive scar tissue or hetero topical ossifications, has a incidence of 74% and may persist up to 14 years after amputation.
- Phantom limb pain (PLP) pain: described as a similar neuropathic (cutting, traction, shock pain) and as a similar nociceptive (deaf, cramp-like, compressive), is present in the first 6 months after amputation, but can last for years, and affects up to 85% of patients.
- Phantom limb sensations (phantom sensations - PSs): non-painful perceptions from the part of the body lost after deafferentation or amputation (kinetic, kinesthetic and exteroceptive), is common in the postoperative period, in one third of patients within 24 hours , in three quarters of patients within 4 days, and in 90% of patients, persist within 6 months of surgery.
At present, the scientific evidence shows that the infusion of local anesthetics with perioperative epidural and perineural catheters correlates with good pain control in the immediate post-operative period expressed in terms of reduced opiate demand by of the patient undergoing limb amputation. However, there are no studies on the medium to long-term incidence of phantom limb syndrome in patients who have been treated with multimodal analgesic protocols. Only the observational study performed by Borghi et al. showed that a 3% incidence of phantom limb syndrome in patients treated with prolonged infusion for an average of 30 days with a 0.5% ropivacaine perineural catheter was shown 12 months after limb amputation surgery. Based on this experience for years at the Rizzoli Orthopedic Institute, peridural and peripheral catheters are applied with a dedicated protocol. At present, however, there is no further assessment of the incidence of phantom limb in patients amputated to the IOR who have followed the protocols in use.
Aim The study aims to evaluate the incidence of phantom pain in the medium term, the sensation of phantom limb and the pain of the stump in amputated trans femoral and trans tibial patients operated on the IOR who followed the perioperative analgesic protocol with use of catheters peridural and peripheral nerves. The results of the study could provide indications about the need to modify the perioperative and rehabilitative analgesic therapy protocol for lower limb amputation surgery to favor a reduction in the intensity, prevalence and frequency of phantom limb syndrome with consequent improvement in the quality of life.
Methods Administration (post delivery and supervised compilation by telephone) of the Prosthetic Evaluation Questionnaire (PEQ), of the Houghton Scale of Prosthetic Use in People with Lower-Extremity Amputations and collection of general information : presence and severity of the stump pain, phantom limb pain and phantom limb sensation, weight, height, type of prosthesis and time of use, specific rehabilitation for phantom limb, pharmacological therapy in place.
Type of anesthesia used during surgery and general and local analgesic therapy (perinervous or peridural catheters) used will be retrieved from clinical folders.
Timetable Month 1
- Request to the Institute Informatic System of the identification of patient records with amputation above or below the knee in the years 2015-2017
- Search for computerized folders and data collection of anesthesia and analgesia in a database Month 2
- Identification of patients eligible for the study with consultation of the registry for the search for the deceased
- Sending patient questionnaires and phone calls for completion Month 3
- Collection of questionnaires
- Completion of the database
- Statistic analysis
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amputees | – | Diagnostic Test: QuestionnairePatients underwent trans-tibial and trans-femoral amputation of any etiology at the Rizzoli Orthopedic Institute from 2015 to 2017 with the presence of analgesia data for surgery in a computerized record (SIR, Rizzoli information system). A questionnaire for the detection of residual limb pain will be administrate to all the survivors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients amputated above and below the knee at the Orthopedic Divisions of the Rizzoli Orthopedic Institute
Key inclusion criteria (3 listed)
- Patients undergoing trans-tibial and trans-femoral amputation of any etiology at the Rizzoli Orthopedic Institute from 2015 to 2017
- Presence of analgesia data for surgery in a computerized record (SIR, Rizzoli information system)
- Patients who have accepted to join the study
Key exclusion criteria (4 listed)
- Patients with a medical record inaccessible via SIR (not yet digitized)
- Deceased patients
- Patients under the age of 18
- Non-ambulatory patients
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 |
|---|---|---|
| QuestionnaireA questionnaire from which the session dedicated to the evaluation of the stump pain, the phantom limb and the sensation of the phantom limb has been extracted will be administered: this is the Prosthetic Evaluation Questionnaire (PEQ) validated in Italian by Ferrero et al. 2005. In the questionnaire sent to patients will be asked also for anthropometric data (weight, height) in addition to the characteristics of the worn prosthesis and if they have followed a period of rehabilitation.The time of use of the prosthesis will be evaluated through the Houghton Scale of Prosthetic Use in People with Lower- Extremity Amputations (19) | Diagnostic test | Amputees |
Primary outcome
Mid-term incidence (1 to 3 years) of pain in the stump or phantom limb and phantom limb sensation in amputated trans femoral and trans tibial patients treated at IOR from 2015 to 2017.
Time frame: 7 days
Data will be obtained by means of questionnaire sent to patients.
Evaluation of the type of anesthesia and perioperative analgesic treatment with peripheral nerve block effected and of the use of the prosthesis to evaluate possible relations with the presence and the entity of the phantom limb.
Time frame: 7 days
Anesthesia data will be retrieved from patient records.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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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.
Maria Grazia Benedetti principal investigator
IRCCS-Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Amputation Above Knee and Lower Limb Amputation Below Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 Jan 2020. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mid-term incidence (1 to 3 years) of pain in the stump or phantom limb and phantom limb sensation in amputated trans femoral and trans tibial patients treated at IOR from 2015 to 2017. (time frame: 7 days). The study lists 2 primary outcomes in all. 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 13 Jan 2020.