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NCT Number: NCT05915065

VR to Evaluate Phantom Limb Pain

The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation.

We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Phantom Limb Pain Amputation Lower Limb Amputation Above Knee (Injury) Lower Limb Amputation Below Knee (Injury) Lower Limb Amputation Knee Lower Limb Amputation at Ankle (Injury) Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Phantom Limb Syndrome With Pain Phantom Pain Phantom Pain Following Amputation of Lower Limb Phantom Pain Following Amputation of Upper Limb Phantom Sensation Postoperative Complications Signs and Symptoms Upper Limb Amputation Above Elbow (Injury) Upper Limb Amputation Below Elbow (Injury) Upper Limb Amputation at the Hand Upper Limb Amputation at the Wrist Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

About this study

The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity limb absence.

Phase 1: Complete in-lab or virtual iterative usability and functionality testing of hardware and software components of The Coapt Phantom Limb Pain Management System to ensure readiness for at-home use - COMPLETED

Phase 2: A clinical trial of The Coapt Phantom Limb Pain Management System during at-home use. We hypothesize that the system will improve PLP for individuals with upper or lower extremity absence, as measured through various questionnaires.

VR systems have been proposed as alternative technologies to treat PLP since they are relatively inexpensive and more readily available. Virtual reality environments allow for real-time control practice utilizing different tasks and games, and have been widely accepted as clinically viable options for administering therapy.

Effective PLP treatment methods are needed for individuals with limb absence that can be utilized on an as-needed basis in the home. VR therapy could potentially be an effective treatment for individuals with chronic upper or lower limb PLP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults over the age of 18 years old
  • Amputation of the upper or lower limb, including amputation of multiple limbs
  • English Speaking
  • Chronic phantom limb pain (at least 6-months duration)
  • Average phantom limb pain intensity of 4 or greater on a 0-10 numerical rating scale
  • Average frequency of phantom limb pain episode of at least twice per month.
  • Residual limb pain of less than 5 on the Numerical Pain Rating Scale
  • Pain medication use stable for > 1 month

Exclusion criteria

  • Unable to tolerate use of liner or cuff on their residual limb
  • Skin irritation/wounds on residual limb that would prevent use of the electrode cuff
  • Significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback.
  • Non-English speaking

Treatment and study plan

Coapt Phantom Limb Pain Management System

Device

The PLP-MS consists of (1) an expandable arm/leg cuff with electrode sensors to collect EMG signals from residual limb muscles, (2) an integrated hardware module (the Coapt Complete Control Gen2.5 system) that translates users' EMG signals into game commands, (3) game software for mobile applications, and (4) a secure, HIPAA-compliant cloud-based data storage system for storing and retrieving user data remotely.

Primary outcomes

  1. Short-form McGill Pain Questionnaire

    Time frame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention

    The primary outcome measure in this study is change in the pain rating index (PRI) between the baseline score and at the post-treatment assessment at the end of the 8-week intervention. The PRI is computed as the sum of the scores for all descriptors of the Short Form of the McGill Pain Questionnaire (SF-MPQ).

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention

    The pain VAS is a unidimensional measure of pain intensity, used to record a persons pain progression, or compare pain severity between paints with similar conditions.

  2. Numerical Pain Rating Scale (NPRS)

    Time frame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention

    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.

  3. Patient-Reported Outcomes Measurement Information Systems (PROMIS)

    Time frame: Baseline score and at the post-treatment assessment at the end of the 8-week intervention

    ROMIS® (Patient-Reported Outcomes Measurement Information System®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults. PROMIS measures can be used with the general population and with individuals living with chronic conditions.

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Coapt, LLC

Registry information

Official study title

Intuitively Controlled Virtual Reality to Treat Phantom Limb Pain

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2023
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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