Does the simulated presentation of the injured arm influence the perception of pain?

Phase 1

• Conditions: S14; G54.6; S48.9; Injury of nerves and spinal cord at neck level; Phantom limb syndrome with pain; Traumatic amputation of shoulder and upper arm, level unspecified

• Registration Number: DRKS00030655
• Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-09
• Study Completion: 2023-05-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Adulthood
- Subjects with upper extremity amputations with pain sensation
- Subjects with brachial plexus injury with paralyzed arm and pain sensation
- Subjects with chronic regional pain syndrome (CRPS) with paralyzed arm and pain sensation
- Sufficient cognitive and communication skills to participate in a series of tests and understand instructions

Exclusion Criteria

- Age under 18 or over 80 years
- Severe neurological comorbidity that limits cognition and movement beyond the arm
- Severe functional limitations of both arms
- Manifest mental disorders (e.g., post-traumatic stress disorder, anxiety disorders)
- Visual limitations that interfere with viewing the virtual image without interference
- Pregnant women
- Addictive behavior, defined as the abuse of drugs

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity and quality:<br>The primary measurements are the pain quality and intensity, which are measured (via questionnaires) at regular intervals throughout the intervention period. Once the intervention period is over these parameters are tracked for one more month.<br>Data:<br>Pain intensity (VAS- Visual Analog Scale), localization, duration and type of phantom pain, perceived position and size of phantom extremity, location of phantom extremity.

Secondary Outcome Measures

Name	Time	Method
VR-usage statistics:<br>The usage of the VR therapy system is automatically logged during the entire intervention period, each time the user initiates a therapy session. <br>These data include:<br>- Frequency and duration of use <br>- Hand usage statistic (e.g., which gestures the user performed or how many hand interactions were performed)<br>- User satisfaction with the VR module