the Influence of Virtual Reality Approach on Phantom Pain in Trans Tibial Amputation

NCT06262503 | Active Not Recruiting

• 1 other identifier: P.T.REC/012/004810
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To investigate the effect of Virtual reality (VR) on phantom limb pain in trans tibial amputation.
2. 2.To investigate the effect of Virtual reality (VR) on lower limb Function in trans tibial amputation.

Conditions

Phantom Pain Following Amputation of Lower Limb

Outcome Measures

Primary Outcomes (2)

• 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 .

  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

  4 weeks

Study Arms (2)

Group1(Control )

OTHER

Will receive conventional physiotherapy for one month and measure the pain intensity and lower extremity function

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

Device: Virtual Reality; Device: Transcutaneous Electrical Nerve Stimulation (TENS); Device: Mirroring Therapy; Other: Phantom Exercises

Interventions

Virtual Reality DEVICE

Virtual Reality device is used for creating 3d avatar to engage the patient into a virtual world so he can overcome his pain

Group2 (Experimental)

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.

Group1(Control ); Group2 (Experimental)

Mirroring Therapy DEVICE

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.

Group1(Control ); Group2 (Experimental)

Phantom Exercises OTHER

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.

Group1(Control ); Group2 (Experimental)

Eligibility Criteria

• Age: 18 Months - 75 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical therapy, Cairo university

Giza, 12613, Egypt

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapy partctitioner

Model Details: Group1:conventional physiotherapy for phantom Pain Group2:conventional physiotherapy and Virtual Reality for phantom Pain

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: October 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

EG (1)