VR to Evaluate Phantom Limb Pain

Shirley Ryan AbilityLab

Status: Active, not recruiting

Conditions: Phantom Pain Following Amputation of Upper Limb; Lower Limb Amputation Knee; Upper Limb Amputation At the Hand; Lower Limb Amputation At Ankle (Injury); Upper Limb Amputation At the Wrist; Amputation; Phantom Pain; Phantom Pain Following Amputation of Lower Limb; Upper Limb Amputation Above Elbow (Injury); Phantom Sensation; Phantom Limb Syndrome with Pain; Upper Limb Amputation Below Elbow (Injury); Phantom Limb Pain; Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Above Knee (Injury)

Treatments: Device: Coapt Phantom Limb Pain Management System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05915065

STU00213205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Phantom Limb Pain Management System during at-home use.

Other group

Description:

Participants attend either in person at Shirley Ryan AbilityLab or virtually via Zoom * Educational documents provided on pain and phantom limb pain. * Participants are measured for an electrode cuff either in person or virtually * Complete several questionnaires. * Provided training on the Phantom Limb Pain Program with use of the electrode cuff and muscular contractions of their limb * Participate in a 8 week home trial (1.5 hours per week of use, 20-40 minutes, 4-5x each week) * Once home trial is complete - participants will be asked to participate in a phone or Zoom call at weeks 16,24 and 32 to repeat questionnaires.

Treatment:

Device: Coapt Phantom Limb Pain Management System