Electrical Stimulus Therapy for Chronic Phantom Limb Pain

NCT03030079 | Completed FDA Device

• 1 other identifier: 16-1063
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to assess the effectiveness of an electrical stimulation therapy option for the treatment of chronic phantom limb pain in upper or lower limb amputees. This therapy has been previously used for sports and joint injuries and is marketed for relaxation of muscle spasms, re-education of muscle action, prevention of disuse atrophy, increased local blood circulation, and maintaining or increasing range of motion. The investigators would like to explore the idea that physically exercising the muscles of the residual limb and increasing blood flow to the site of amputation through the promotion of motor contraction using electrical stimulation decreases chronic phantom limb pain.

Conditions

Phantom Limb Pain

Outcome Measures

Primary Outcomes (2)

• Use of electrical stimulus medium frequency alternating current for short term decreased Phantom Limb Pan

  Pain level data will be taken before and after each session to analyze any short term decreases in pain using a self-reported numeric 10-point pain scale. T- tests will be used for within subject testing looking at pre and post treatment measures to quantify a decrease in pain.

  After each 20 minute treatment session up to 5 weeks

• Assess the effectiveness of reducing chronic phantom limb pain long term.

  An overall sustained decrease in phantom limb pain will be assessed weekly using a self-reported numeric 10-point pain scale. ANOVAs will be used to look at trends in post treatment measures over time.

  Weekly for 5 weeks

Study Arms (1)

Experimental Electrical stimulation Regimen

EXPERIMENTAL

Explore the efficacy of an electrical stimulus regimen on the treatment of chronic phantom limb pain using a standard-of-care electrical stimulation system

Device: Experimental Electrical Stimulation Regimen

Interventions

Experimental Electrical Stimulation Regimen DEVICE

The electrodes will pass an electrical current through the skin and into the muscle first at a low intensity for 5 minutes to allow the subject to adjust to the sensation. The current will then be gradually increased to a level sufficient to elicit a non-painful motor contraction. The subject will sit in a relaxed position as the electrical stimulator contracts the muscles for a duration of 15 minutes.

Also known as: Device: Omnistim FX2 Pro

Experimental Electrical stimulation Regimen

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified adult volunteers with a limb deficiency with a well-healed site of amputation
• Subjects experiencing at least a 4 out of 10 of chronic phantom limb pain based on a numeric 10-point pain scale.
• Any ethnicity and gender
• Age (18-85 years)
• Able to understand and follow directions in English, assessed by their ability to respond during the recruitment and consent processes.

You may not qualify if:

• Subjects that are not able to understand the procedures and who are unable to come to the facility.
• Any individual whose amputation site is not completely healed
• Anyone with cardiac demand pacemakers and/or implanted defibrillator.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Hanger Clinic: Prosthetics & Orthotics: collaborator

Study Sites (1)

Children's Hospital Colorado Research Institute

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Richard Weir, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 24, 2017
• Study Start: January 1, 2017
• Primary Completion: June 27, 2023
• Study Completion: June 28, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)