## Protocol Section
### Identification Module
**NCT ID:** NCT03030079

**Brief Title:** Electrical Stimulus Therapy for Chronic Phantom Limb Pain

**Official Title:** Exploratory Study of Electrical Stimulus as a Treatment Option for Chronic Phantom Limb Pain

#### Organization Study ID Info
**ID:** 16-1063
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Denver
### Status Module
#### Completion Date
**Date:** 2023-06-28

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-11

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-06-27

**Type:** ACTUAL

#### Start Date
**Date:** 2017-01-01

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2017-01-24
**Type:** ESTIMATED
**Study First Submit Date:** 2017-01-13
**Study First Submit QC Date:** 2017-01-19
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Hanger Clinic: Prosthetics & Orthotics

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Colorado, Denver

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** There are a large number of people living with an amputation due mainly to cardiovascular disease, diabetes, and trauma; and of these there is evidence to show that up to 80% of amputees experience phantom limb pain (PLP). PLP is classified as cramping, burning, shooting, or stabbing pain in the missing limb following an amputation. Current treatments include pharmacological drugs, anesthesia, additional surgery, mirror therapy, transcutaneous electrical nerve stimulation (TENS) and others. TENS, as usually implemented, has been used to effectively reduce pain in multiple spots of the body, but has shown little effect in reducing phantom limb pain especially long term even with varying the frequency and intensity of the electrical stimulation. These current treatments can be invasive, costly, and have shown only to offer immediate relief. Using an electrical stimulator at a higher intensity has proven to to reduce pain and increase healing in numerous sports and joint related injuries. Anecdotally, the investigators have learned that a similar treatment protocol when applied to persons with phantom limb pain can mitigate their pain. The goal of this pilot study is to assess the effectiveness of higher intensity electrical stimulation in the management of PLP and also to acquire data to inform the investigators to the most appropriate study design and power for a future more formal clinical trial. To accomplish this the investigators will utilize the ACP Omnistim FX2 Pro electrical stimulator, that has been provided to us by Accelerated Care Plus (ACP) Corporation, to physically exercise the muscles of the residual limb and hence increase the local blood flow and explore it's potential for treatment of PLP both short and long term. The self-identified subject will be hooked up to the ACP electrical stimulator using surface electrodes that will pass a current through the skin first at a low intensity for 5 minutes to allow the subject to adjust to the tingling sensation. The current will then be gradually increased to a level sufficient to elicit a non-painful motor contraction for 15 minutes. Using a numerical pain scale and short answer questions about the characteristics of the pain the investigators will track both short term and long term changes in pain.

### Conditions Module

**Conditions:**

- Phantom Limb Pain

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DEVICE_FEASIBILITY

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Experimental Electrical Stimulation Regimen

**Label:** Experimental Electrical stimulation Regimen

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental Electrical stimulation Regimen

**Description:** 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.

**Name:** Experimental Electrical Stimulation Regimen

**Other Names:**

- Device: Omnistim FX2 Pro

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Use of electrical stimulus medium frequency alternating current for short term decreased Phantom Limb Pan

**Time Frame:** After each 20 minute treatment session up to 5 weeks

**Description:** 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.

**Measure:** Assess the effectiveness of reducing chronic phantom limb pain long term.

**Time Frame:** Weekly for 5 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Healthy Volunteers:** True

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aurora

**Country:** United States

**Facility:** Children's Hospital Colorado Research Institute

**State:** Colorado

**Zip:** 80045

#### Overall Officials

**Official 1:**

**Affiliation:** University of Colorado, Denver

**Name:** Richard Weir, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010468

- Term: Perceptual Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010149

- Term: Pain, Postoperative

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13498

- Name: Phantom Limb

- Relevance: HIGH

- As Found: Phantom Limb

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13379

- Name: Perceptual Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M13069

- Name: Pain, Postoperative

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010591

- Term: Phantom Limb

### Misc Info Module

- Version Holder: 2024-05-24
