Phantom Pain Following Amputation of Lower LimbNCT06262503
the Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation
A study testing Virtual Reality, Transcutaneous Electrical Nerve Stimulation (TENS) and Mirroring Therapy in people with Phantom Pain Following Amputation of Lower Limb, run by Cairo University at 1 site in Egypt.
Trial summary
1. To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation. 2. To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation. Read more about this study
- Who is it for?
- Ages 18 to 75 months
- Conditions the study is for
- Phantom Pain Following Amputation of Lower Limb
- What is being tested?
- Virtual Reality, Transcutaneous Electrical Nerve Stimulation (TENS) and Mirroring Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to Mar 2024
- Phase
- Interventional
- 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 to 75 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All participants were prescreened older than 18 years; able to provide informed consent; with unilateral traumatic Factors Phantom Limb Pain lower limb amputation after complete recovery.
- chronic PLP for more than 3 months.
- If the subject was taking any medications, dosages must have been stable for at least 2 weeks before enrollment in the study.
- Normal Body mass index ranged from 18.5 to 24.9.
Who cannot join
- History of alcohol or drug abuse within the past 6 months.
- Medical history of photophobia, epilepsy or any other light sensitivity.
- Visual impairment thought to render the test invalid (people who need to wear glasses day to day are not excluded.
- Uncontrolled epilepsy or prior seizures within the past year.
- History of unexplained fainting spells or loss of consciousness as self-reported during the past 2 years.
- Mirror therapy within 3 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation: A Randomized Control Trail
- To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation.
- To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation.
A sample size of 60 will be randomly allocated to two groups(30 in each group) , by using computer-generated random number list method. Control group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) for reducing phantom pain in trans -tibial amputation and the experimental group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) and Virtual Reality for reducing phantom pain in trans -tibial amputation .
Read the detailed description
Pain management has become an increasingly important healthcare concern in clinical practice.
The investigators use the phrase (phantom nerve pain) for pain described by patients related to the absence of sensation. Though simple numbness is often well-tolerated and not bothersome, phantom nerve pain develops for some patients.
The painful area is essentially numb yet painful, hence the term "anesthesia dolorosa," which translates as "painfully numb." In a similar way to amputees who have phantom limb pain (PLP) in a limb no longer present, patients with peripheral nerve injury can have phantom nerve pain in the denervated area. The investigators hypothesize that damage to the peripheral first-order neurons, along with spontaneously firing second-order neurons, causes this pain and, if not treated in a timely manner, results in cortical remodeling and centrally mediated pain (as in phantom limb pain).
Phantom limb pain (PLP) is experienced by 65-85% of limb amputees. In addition, a range of other sensations can originate in the missing limb including phantom limb awareness, phantom sensations (such as itching and pins and needles), and kinetic and kinesthetic sensations (movement and position in space). Traditionally the treatment target has been PLP; however, it has become clear over many years that treatment options have limited success.
Although in many cases these phenomena do not cause suffering, phantom limb- distortions often co-occur with phantom limb pain (PLP) , in other words, a painful sensation located in the phantom and thus outside the physical borders of the body. PLP is reported by the majority of amputees , accounts for a significant reduction in health-related quality of life and only insufficiently responds to conventional pharmacological interventions The large variation in symptomatology suggests a multifactorial origin of phantom phenomena. It has been shown that the amputation induces negative effects on peripheral and central physiological mechanisms, both contributing to the experience of phantom phenomena including PLP.
The two most common types of Lower limb Amputation (LLAs) are transfemoral amputation (TFA) and trans-tibial amputation (TTA). TFAs make up 31% of all amputations, and TTAs make up 39% of all amputations .
Virtual Reality (VR) is characterized by an artificial computer-generated environment created to replace real-world sensory inputs ,It uses a computer to generate a simulation environment, which the users interact with, providing an immersive experience that facilitates the perception of being physically present in the virtual environment. In recent years, with the advent of more affordable devices such as head-mounted displays, VR has become a more feasible and popular technology ). Unlike many analgesics, which disrupt the C-fiber pathway that relays nociceptive signals to the central nervous system, VR affects pain perception through attention, concentration, and emotional alteration.( The immersive environment created by VR reduces pain experience by up-regulating nonpainful neural signaling. Increasing evidence supports VR as an alternative strategy for acute, burn, and experimental pain management in both adults and children. Additional experiments have demonstrated the positive effect of VR on pain in a variety of medical procedures including chemotherapy and wound care.
With immersive technology, participants view the full panorama, which enables the creation of a high sense of presence and immersion as if the participant is essentially inside the created environment.
One of the strategies for the management of PLP is phantom motor execution (PME), also known as phantom exercises. PME involves the imaginary movement of phantom limb in the brain along with the performance of certain actual physical movements. Neurophysiological networking involved in PME is similar to that of actual executed physical activities of sound limb and it should be distinguished from pure imaginary activities as it follows a different neurophysiological pathway . Such exercises have been shown to safely and effectively relieve PLP in various types of limb amputations .
- Being tested
- Virtual Reality, Transcutaneous Electrical Nerve Stimulation (TENS), Mirroring Therapy, Phantom Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Virtual Reality device is used for creating 3d avatar to engage the patient into a virtual world so he can overcome his pain
Transcutaneous Electrical Nerve Stimulation (TENS)Device
TENS stimulation plays on pain gate theory it sends stimulation to close C-fibers to relieve the pain and make the patient comfortable. The electrodes were put around the stump leg (residual limb) and the session lasts for 15 minutes, the parameters were Conventional TENS - high frequency (50-100 Hz), low intensity, short pulse width (50-200 μs). Pain relief by means of the pain gate mechanism involves activation (excitation) of the A beta (Aβ) sensory fibers, and by doing so, reduces the transmission of the noxious stimulus from the 'c' fibers, through the spinal cord and hence on to the higher centers.
Mirroring TherapyDevice
Mirroring Therapy :it tricks the brain. By placing a mirror between the healthy limb and the missing limb, patients see a reflection of the healthy limb, essentially "replacing" the phantom limb with a visual representation. This visual feedback is thought to reactivate brain areas responsible for the missing limb, potentially restoring its representation and reducing the discomfort of PLP. Essentially it aims to heal the brain's image of the body, which might in turn alleviate the pain associated with the missing limb.
Phantom ExercisesOther
The study investigated phantom exercises (PE) for phantom limb pain (PLP) relief. Patients performed specific foot and leg movements 15 times, stopping if PLP disappeared early. Exercises were repeated daily or upon PLP recurrence. Patients imagined their phantom limb position and mimicked it with their remaining limb, performing ankle, foot, knee, and hip movements until relaxation and PLP subsided.
| Study group | Role | What they receive |
|---|---|---|
| Group1(Control ) | Other | Will receive conventional physiotherapy for one month and measure the pain intensity and lower extremity function Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Device: Mirroring Therapy; Other: Phantom Exercises |
| Group2 (Experimental) | Experimental | Will receive conventional physiotherapy and Virtual Reality for phantom Pain for one month and measure the pain intensity and lower extremity function Receives: Device: Virtual Reality; Device: Transcutaneous Electrical Nerve Stimulation (TENS); Device: Mirroring Therapy; Other: Phantom Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Level
Pain Intensity Level is measured by McGill Pain Questionnaire to determine the pain level The McGill Pain Questionnaire. The descriptors fall into four major groups: sensory (S)1-10, affective (A) 11-15, evaluative (E), 16 and miscellaneous (M)17-20. The rank value for each descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PRI). The present pain intensity (PPI) is based on a scale of (0-5) 0 refers to no pain and 5 refers to worst pain and know the effectiveness of the Virtual Reality wither pain is increased or decreased .
Measured: 4 weeks
Lower Extremity Functional
Lower Extremity Functional is measured by Lower Extremity Functional Scale (LEFS) to know the progress of patient movement and balance.It is divided to 5 categories; 0 indicates extreme difficult or unable to perform activity, 1 indicates quite a bit of difficulty, 2 indicates moderate difficulty, 3 indicates a little bit of difficulty, 4 indicates no difficulty
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Oct 2023
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Pain Following Amputation of Lower LimbStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group1:conventional physiotherapy for phantom Pain Group2:conventional physiotherapy and Virtual Reality for phantom Pain
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Medhat Helal Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262503
- Sponsor's protocol ID
- P.T.REC/012/004810
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation: A Randomized Control Trail
- ClinicalTrials.gov ID
- NCT06262503
- Acronym / sponsor ID
- P.T.REC/012/004810
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 16 Feb 2024 (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.
- To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation.
- To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation.
A sample size of 60 will be randomly allocated to two groups(30 in each group) , by using computer-generated random number list method. Control group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) for reducing phantom pain in trans -tibial amputation and the experimental group will receive conventional physiotherapy(TENS- Phantom exercises and mirroring exercise) and Virtual Reality for reducing phantom pain in trans -tibial amputation .
Detailed description
Pain management has become an increasingly important healthcare concern in clinical practice.
The investigators use the phrase (phantom nerve pain) for pain described by patients related to the absence of sensation. Though simple numbness is often well-tolerated and not bothersome, phantom nerve pain develops for some patients.
The painful area is essentially numb yet painful, hence the term "anesthesia dolorosa," which translates as "painfully numb." In a similar way to amputees who have phantom limb pain (PLP) in a limb no longer present, patients with peripheral nerve injury can have phantom nerve pain in the denervated area. The investigators hypothesize that damage to the peripheral first-order neurons, along with spontaneously firing second-order neurons, causes this pain and, if not treated in a timely manner, results in cortical remodeling and centrally mediated pain (as in phantom limb pain).
Phantom limb pain (PLP) is experienced by 65-85% of limb amputees. In addition, a range of other sensations can originate in the missing limb including phantom limb awareness, phantom sensations (such as itching and pins and needles), and kinetic and kinesthetic sensations (movement and position in space). Traditionally the treatment target has been PLP; however, it has become clear over many years that treatment options have limited success.
Although in many cases these phenomena do not cause suffering, phantom limb- distortions often co-occur with phantom limb pain (PLP) , in other words, a painful sensation located in the phantom and thus outside the physical borders of the body. PLP is reported by the majority of amputees , accounts for a significant reduction in health-related quality of life and only insufficiently responds to conventional pharmacological interventions The large variation in symptomatology suggests a multifactorial origin of phantom phenomena. It has been shown that the amputation induces negative effects on peripheral and central physiological mechanisms, both contributing to the experience of phantom phenomena including PLP.
The two most common types of Lower limb Amputation (LLAs) are transfemoral amputation (TFA) and trans-tibial amputation (TTA). TFAs make up 31% of all amputations, and TTAs make up 39% of all amputations .
Virtual Reality (VR) is characterized by an artificial computer-generated environment created to replace real-world sensory inputs ,It uses a computer to generate a simulation environment, which the users interact with, providing an immersive experience that facilitates the perception of being physically present in the virtual environment. In recent years, with the advent of more affordable devices such as head-mounted displays, VR has become a more feasible and popular technology ). Unlike many analgesics, which disrupt the C-fiber pathway that relays nociceptive signals to the central nervous system, VR affects pain perception through attention, concentration, and emotional alteration.( The immersive environment created by VR reduces pain experience by up-regulating nonpainful neural signaling. Increasing evidence supports VR as an alternative strategy for acute, burn, and experimental pain management in both adults and children. Additional experiments have demonstrated the positive effect of VR on pain in a variety of medical procedures including chemotherapy and wound care.
With immersive technology, participants view the full panorama, which enables the creation of a high sense of presence and immersion as if the participant is essentially inside the created environment.
One of the strategies for the management of PLP is phantom motor execution (PME), also known as phantom exercises. PME involves the imaginary movement of phantom limb in the brain along with the performance of certain actual physical movements. Neurophysiological networking involved in PME is similar to that of actual executed physical activities of sound limb and it should be distinguished from pure imaginary activities as it follows a different neurophysiological pathway . Such exercises have been shown to safely and effectively relieve PLP in various types of limb amputations .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group1:conventional physiotherapy for phantom Pain Group2:conventional physiotherapy and Virtual Reality for phantom Pain
| Arm | Type | Receives |
|---|---|---|
| Group1(Control ) | Other | Device: Transcutaneous Electrical Nerve Stimulation (TENS), Device: Mirroring Therapy, Other: Phantom ExercisesWill receive conventional physiotherapy for one month and measure the pain intensity and lower extremity function |
| Group2 (Experimental) | Experimental | Device: Virtual Reality, Device: Transcutaneous Electrical Nerve Stimulation (TENS), Device: Mirroring Therapy, Other: Phantom ExercisesWill receive conventional physiotherapy and Virtual Reality for phantom Pain for one month and measure the pain intensity and lower extremity function |
Who may qualify
- Ages
- 18 to 75 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All participants were prescreened older than 18 years; able to provide informed consent; with unilateral traumatic Factors Phantom Limb Pain lower limb amputation after complete recovery.
- chronic PLP for more than 3 months.
- If the subject was taking any medications, dosages must have been stable for at least 2 weeks before enrollment in the study.
- Normal Body mass index ranged from 18.5 to 24.9.
Key exclusion criteria (6 listed)
- History of alcohol or drug abuse within the past 6 months.
- Medical history of photophobia, epilepsy or any other light sensitivity.
- Visual impairment thought to render the test invalid (people who need to wear glasses day to day are not excluded.
- Uncontrolled epilepsy or prior seizures within the past year.
- History of unexplained fainting spells or loss of consciousness as self-reported during the past 2 years.
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 |
|---|---|---|
| Virtual RealityVirtual Reality device is used for creating 3d avatar to engage the patient into a virtual world so he can overcome his pain | Device | Group2 (Experimental) |
| Transcutaneous Electrical Nerve Stimulation (TENS)TENS stimulation plays on pain gate theory it sends stimulation to close C-fibers to relieve the pain and make the patient comfortable. The electrodes were put around the stump leg (residual limb) and the session lasts for 15 minutes, the parameters were Conventional TENS - high frequency (50-100 Hz), low intensity, short pulse width (50-200 μs). Pain relief by means of the pain gate mechanism involves activation (excitation) of the A beta (Aβ) sensory fibers, and by doing so, reduces the transmission of the noxious stimulus from the 'c' fibers, through the spinal cord and hence on to the higher centers. | Device | Group1(Control ), Group2 (Experimental) |
| Mirroring TherapyMirroring Therapy :it tricks the brain. By placing a mirror between the healthy limb and the missing limb, patients see a reflection of the healthy limb, essentially "replacing" the phantom limb with a visual representation. This visual feedback is thought to reactivate brain areas responsible for the missing limb, potentially restoring its representation and reducing the discomfort of PLP. Essentially it aims to heal the brain's image of the body, which might in turn alleviate the pain associated with the missing limb. | Device | Group1(Control ), Group2 (Experimental) |
| Phantom ExercisesThe study investigated phantom exercises (PE) for phantom limb pain (PLP) relief. Patients performed specific foot and leg movements 15 times, stopping if PLP disappeared early. Exercises were repeated daily or upon PLP recurrence. Patients imagined their phantom limb position and mimicked it with their remaining limb, performing ankle, foot, knee, and hip movements until relaxation and PLP subsided. | Other | Group1(Control ), Group2 (Experimental) |
Primary outcome
Pain Intensity Level
Time frame: 4 weeks
Pain Intensity Level is measured by McGill Pain Questionnaire to determine the pain level The McGill Pain Questionnaire. The descriptors fall into four major groups: sensory (S)1-10, affective (A) 11-15, evaluative (E), 16 and miscellaneous (M)17-20. The rank value for each descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PRI). The present pain intensity (PPI) is based on a scale of (0-5) 0 refers to no pain and 5 refers to worst pain and know the effectiveness of the Virtual Reality wither pain is increased or decreased .
Lower Extremity Functional
Time frame: 4 weeks
Lower Extremity Functional is measured by Lower Extremity Functional Scale (LEFS) to know the progress of patient movement and balance.It is divided to 5 categories; 0 indicates extreme difficult or unable to perform activity, 1 indicates quite a bit of difficulty, 2 indicates moderate difficulty, 3 indicates a little bit of difficulty, 4 indicates no difficulty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality, Transcutaneous Electrical Nerve Stimulation (TENS) and Mirroring Therapy in people with Phantom Pain Following Amputation of Lower Limb, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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 Egypt. 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?
Results are not available in the source record.
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 Intensity Level (time frame: 4 weeks). 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 20 Feb 2024.