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Can a different prosthetic socket ease back pain for amputees?

NCT ID NCT07768072

Knowledge-focused Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This study looks at how two types of prosthetic sockets—ischial-containment (IC) and sub-ischial (SI)—affect pelvic movement and low back pain in people with above-knee amputations. Researchers will measure pelvic tilt and muscle activity while participants walk and stand, comparing them to able-bodied controls. The goal is to understand how socket design influences spinal motion and compensations that may lead to low back pain, potentially guiding future prosthetic and therapeutic interventions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Comparison of ischial-containment (IC) and sub-ischial (SI) prosthetic sockets
What this could lead to
If this trial succeeds, it could guide better prosthetic socket choices and new therapies to prevent or ease low back pain in above-knee amputees, improving mobility and quality of life.
What could go wrong
This is a small observational study (45 participants) that measures movement patterns, not long-term outcomes. Results may not apply to all amputees, and differences between socket types might be subtle.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Thirty unilateral transfemoral prosthesis users (15 with an ischial containment socket and 15 with a sub-ischial socket) and 15 able-bodied control participants.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For all participants: * Ability to complete the experimental protocol without undue fatigue or health risks * Low Back Pain scale assessment (0-10) less than 4 (activities of daily living or quality of life not impacted) In addition for persons with lower limb amputation: * Prosthesis user for a minimum of 2 years with their current socket design * Good fit with either an ischial containment (IC) or sub-ischial (SI) socket * Good skin integrity on their residual limb upon visual inspection * Does not require the use of assistive devices to walk Exclusion Criteria: * Previously diagnosed with a spine condition (e.g., pinched nerve, bulging disc, etc.) * Previously diagnosed with an orthopedic or neuromuscular condition that may affect walking or balance (e.g., ankle fusion, Parkinson's disease, stroke, etc.)

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Conditions

The condition(s) this trial relates to.

Low Back Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unilateral transfemoral amputation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois, 60612, United States