10 Participants NeededMy employer runs this trial

Support Pillow for Spine Surgery Recovery

PC
Overseen ByPamela C Zuckerman, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Montefiore Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The present study investigates the feasibility of a support pillow for use after spinal surgical procedures, and more particularly, to protect the midline region of the back following spinal surgery.

Existing cushioning pillows do not accommodate the anatomy of the human back nor the requirements of isolating a vertical spinal incision. For example, donut-style or ring-shaped pillows are designed for entirely different purposes, such as hemorrhoidal relief, and cannot provide the desired spinal relief. As a result, there is no suitable, dedicated support structure that allows a patient to rest on their back while eliminating pressure on the surgical site. Accordingly, there is a need for a device that permits postoperative spinal surgery patients to sit or lie in a supine or reclined position without the surgical incision contacting or being compressed by any supporting surface.

Who Is on the Research Team?

AE

Ananth Eleswarapu, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who have had lumbar fusion (lower back) surgery and agree to participate. People under 18 years old cannot join.

Inclusion Criteria

I am an adult who had lumbar fusion surgery and agreed to join the study.

Exclusion Criteria

I am 18 years old or younger.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive the back saver pillow post-surgery and are surveyed on its use and effectiveness

2 weeks
3 visits (in-person)

Follow-up

Participants are monitored for feedback on pillow comfort and pain reduction

2 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Surgical Recovery Support Pillow

Trial Overview

The study is testing a specially designed support pillow meant to protect the surgical area on the back after spine surgery, helping patients rest or sit without putting pressure on their incision.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ParticipantExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+