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Behavioural Intervention

VR Therapy for Phantom Limb Pain

N/A

Recruiting

Led By Levi Hargrove, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic phantom limb pain (at least 6-months duration)

Amputation of the upper or lower limb, including amputation of multiple limbs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline score and at the post-treatment assessment at the end of the 8-week intervention

Awards & highlights

Study Summary

This trial seeks to develop a virtual rehab system to treat Phantom Limb Pain for those with upper/lower limb amputations. Outcome measures & q's will track results.

Who is the study for?

This trial is for adults over 18 with upper or lower limb amputations who have chronic phantom limb pain (PLP) of moderate intensity and frequency. Participants must speak English, have stable medication use, and can't have skin issues on the residual limb, significant cognitive deficits, visual impairments that affect consent or participation, or be non-English speaking.Check my eligibility

What is being tested?

The study tests a virtual rehabilitation system called Coapt Phantom Limb Pain Management System to treat PLP in individuals with various types of limb amputations. The effectiveness will be measured using outcome measures and questionnaires.See study design

What are the potential side effects?

While specific side effects are not detailed here, participants may experience discomfort related to the use of virtual reality equipment such as dizziness or nausea. Any irritation from the liner or cuff used on their residual limbs could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had phantom limb pain for at least 6 months.

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I have had an amputation of a limb or limbs.

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My pain level is below 5 on a scale of 0-10.

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My phantom limb pain averages 4 or more on a pain scale.

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I experience phantom limb pain at least twice a month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline score and at the post-treatment assessment at the end of the 8-week intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline score and at the post-treatment assessment at the end of the 8-week intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline score and at the post-treatment assessment at the end of the 8-week intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Short-form McGill Pain Questionnaire

Secondary outcome measures

Numerical Pain Rating Scale (NPRS)

Patient-Reported Outcomes Measurement Information Systems (PROMIS)

Visual Analogue Scale (VAS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phantom Limb Pain Management System during at-home use.Experimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor

194 Previous Clinical Trials

16,888 Total Patients Enrolled

Coapt, LLCIndustry Sponsor

2 Previous Clinical Trials

17 Total Patients Enrolled

Levi Hargrove, PhDPrincipal InvestigatorShirley Ryan AbilityLab

4 Previous Clinical Trials

298 Total Patients Enrolled

Media Library

Coapt Phantom Limb Pain Management System (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05915065 — N/A

Amputation Research Study Groups: Phantom Limb Pain Management System during at-home use.

Amputation Clinical Trial 2023: Coapt Phantom Limb Pain Management System Highlights & Side Effects. Trial Name: NCT05915065 — N/A

Coapt Phantom Limb Pain Management System (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05915065 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to join this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical research was first publicized on October 1st 2020 and is actively inviting participants. The study requires 24 patients from one facility alone."

Answered by AI

How many participants are registered for this research project?

"Affirmative. According to the clinicaltrials.gov website, this experiment is actively enrolling patients at present time. It was first posted on October 1st 2020 and has recently been updated on June 13th 2023. The study requires 24 unique participants from a single site in total for completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

VR to Evaluate Phantom Limb Pain

Levi Hargrove 2020. "VR to Evaluate Phantom Limb Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05915065.