Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06262503 |
| Other study ID # |
P.T.REC/012/004810 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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 .
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 .
