VR to Evaluate Phantom Limb Pain

Amputation Clinical Trial

Official title:

Intuitively Controlled Virtual Reality to Treat Phantom Limb Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915065
• Other study ID #: STU00213205
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2023
• Source: Shirley Ryan AbilityLab
• Contact: Suzanne Finucane
• Phone: 312-238-0937
• Email: sfinucane[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Lower Limb Amputation Above Knee (Injury)
• Lower Limb Amputation at Ankle (Injury)
• Lower Limb Amputation Below Knee (Injury)
• Lower Limb Amputation Knee
• Phantom Limb
• Phantom Limb Pain
• Phantom Limb Syndrome With Pain
• Phantom Pain
• Phantom Pain Following Amputation of Lower Limb
• Phantom Sensation
• Upper Limb Amputation at the Hand
• Upper Limb Amputation at the Wrist
• Upper Limb Amputation Below Elbow (Injury)
• Wounds and Injuries

Intervention

Device:
• Coapt Phantom Limb Pain Management System
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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Coapt, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-form McGill Pain Questionnaire	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).	Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Secondary	Visual Analogue Scale (VAS)	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.	Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Secondary	Numerical Pain Rating Scale (NPRS)	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.	Baseline score and at the post-treatment assessment at the end of the 8-week intervention
Secondary	Patient-Reported Outcomes Measurement Information Systems (PROMIS)	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.	Baseline score and at the post-treatment assessment at the end of the 8-week intervention