Stimulation for Amputation Pain Management

NCT07759219 | Not Yet Recruiting FDA Device

• 1 other identifier: 2317118
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to see if electrical stimulation applied through the application of a wearable suit improves pain and function among adults with lower-limb amputation who report pain in two or more body regions. The main questions this study seeks to answer are:

• Does the suit provide a viable treatment option for pain management?
• Does the intensity of electrical stimulation matter? Researchers will compare two different intensities of electrical stimulation applied through application of a wearable suit to see the immediate, sustained and cumulative effects on pain and function among adults with lower-limb amputation. Participants will:
• Fill out questionnaires online.
• Undergo two onsite clinical examinations.
• Complete 10 treatment sessions over 2-3 weeks.

Conditions

Amputation Pain

Keywords

pain; amputation; electrical stimulation

Outcome Measures

Primary Outcomes (3)

• Pain Intensity

  Using Numeric Pain Rating Scale, where 0=no pain and 10=worst imaginable pain

  Immediately following treatment sessions 2-3 weeks post-baseline

• Pain Interference

  Patient Reported Outcome Measurement Information System (PROMIS) 29-item: Pain Interference Subscale: reported as a T-score where 50 represents the mean of the United States (US) population and every 10 points above 50 represents one standard deviation above the US mean (more pain interference) and every 10 points below 50 represents one standard deviation below the US mean (less pain interference)

  Immediately following treatment sessions 2-3 weeks post-baseline

• Global Rating of Change

  Participants will rate their overall improvement on a 15-point scale that ranges from -7 (a very great deal worse) to +7 (a very great deal better).

  Immediately following treatment sessions 2-3 weeks post-baseline

Secondary Outcomes (8)

• Self-Reported Physical Function

  Immediately following treatment sessions 2-3 weeks post-baseline

• 6-Minute Walk Test

  Immediately following treatment sessions 2-3 weeks post-baseline

• Self-Selected Gait Speed

  Immediately following treatment sessions 2-3 weeks post-baseline

• Fast Gait Speed

  Immediately following treatment sessions 2-3 weeks post-baseline

• Chair Rise

  Immediately following treatment sessions 2-3 weeks post-baseline

Study Arms (2)

Strong but Comfortable TENS

EXPERIMENTAL

Participants in this group will received 'strong but comfortable' intensity transcutaneous electrical stimulation (TENS) for up to 10 treatment sessions over 2 weeks.

Device: Strong But Comfortable TENS

Just Perceptible TENS

EXPERIMENTAL

Participants in this group will receive 'just perceptible' intensity transcutaneous electrical stimulation (TENS) for up to 10 treatment sessions over 2 weeks.

Device: Just Perceptible TENS

Interventions

Strong But Comfortable TENS DEVICE

All pads of the electrical stimulation suit will be turned on to an intensity that is perceived as 'strong but comfortable', but without a muscle contraction. Transcutaneous electrical stimulation (TENS) intensities will be recorded each visit and determined at each treatment session, without referencing prior stimulation intensities. TENS will be applied for 40 minutes.

Strong but Comfortable TENS

Just Perceptible TENS DEVICE

All pads of the electrical stimulation suit will be turned on to a 'just perceptible' intensity. Transcutaneous electrical stimulation (TENS) intensities will be recorded each visit and determined at each treatment session, without referencing prior stimulation intensities. TENS will be applied for 40 minutes.

Just Perceptible TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking and reading to enable informed consent and participation
• Report of pain in 2/more body regions for at least 3 months duration per site • Report of at least moderate intensity pain over the past 7 days

You may not qualify if:

• An amputation of the contralateral lower-limb \> toe-level
• Do not currently use a prosthesis to ambulate
• Diagnosed cognitive impairment (e.g., dementia, traumatic brain injury)
• Severe vision (e.g., blind) or hearing loss (e.g., deaf)
• Are currently pregnant
• Active cancer/malignancy
• Open wound in any area that is covered by the suit
• An acute infection or injury (e.g., fracture)
• Deep vein thrombosis
• Bowel and/or bladder incontinence

Sponsors & Collaborators

• University of Delaware: lead
• International Institute of Orthotics and Prosthetics: collaborator

Study Sites (1)

International Institute of Orthotics and Prosthetics

Tampa, Florida, 33634, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

J. Megan Sions, PT, DPT, PhD

CONTACT

302-831-7231; megsions@udel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Random assignment, stratified by sex given sex-specific differences in pain following lower-limb amputation, will be used. Participants will be randomly allocated to each of the treatment arms, i.e., 'strong but comfortable' transcutaneous electrical stimulation or 'just perceptible' transcutaneous electrical stimulation at a 2:1 ratio.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual patient participant data that underlie results will be available beginning 3 months following publication of the primary results and ending 5 years following publication of the primary results to researchers who provide a methodologically sound proposal and complete a data sharing agreement.
• Access Criteria: Proposals should be directed to J. Megan Sions, PT, DPT, PhD, the study's principal investigator, in writing at megsions@udel.edu. To gain access to individual patient participant data, requestors will need to sign a data access agreement with the principal investigator's home institution, i.e., the University of Delaware.

Locations

US (1)