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NCT Number: NCT07720856

Surgical Recovery Support Pillow for Spine Surgeries

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.

Recruiting

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Key information

Conditions

Spine Surgery Complications Infection Infections

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The investigators hypothesize that use of the back saver pillow as currently designed will be feasible and that patients will report subjective improvement in pain when applying the pillow. Our specific aims are two-fold, namely (1) Determine if patients are able to utilize the back saver pillow as currently designed and (2) Survey patients as to whether they feel the back saver pillow was beneficial for their recovery.

Our study design is as follows. Eligible patients will be asked pre-op whether they would like to be part of this study and asked for informed consent prior to surgery. A total of 10 patients will be recruited. Enrolled patients will be provided with the back saver pillow either while admitted, if inpatient, or at the time of discharge for same-day surgery patients. Patients will be asked to fill out a survey with questions related to how easy the pillow was to use and whether they found it to reduce their pain on the rating scale of 1-10, where 1 is no pain and 10 is most painful. There will be 3 survey timepoints post-surgery: (1) on the day following surgery, (2) right before discharge and (3) 2-weeks post-surgery. Surveys will assess patient feedback about ease of use, and pain, first without the pillow in the supine position and sitting up with the back against another surface, then with the pillow in the supine position and sitting up with the back against another surface.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients who have lumbar fusion surgery, who consent to participate

Exclusion criteria

  • Pediatric patients 18 years old and under

Treatment and study plan

Surgical Recovery Support Pillow

Device

The Surgical Recovery Support Pillow for Spine Surgeries is a pillow with an open space in the middle in the shape of the spine. The space can accommodate the healing of the surgical site wound by minimizing friction between pillow and spinal wound which can lead to disruption of the sutures and infections. In contrast, normal pillows do not have a central open space in the shape of the spine, and does not minimize the wound friction.

Primary outcomes

  1. Pillow use

    Time frame: One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery

    Pillow use will be measured as a dichotomous measure of whether or not the pillow was used. Results will be summarized.

Secondary outcomes

  1. Pillow comfort and pain

    Time frame: One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery

    Pillow comfort and pain will be assessed as a single composite measure on a scale from 1 to 10, with 1 being very little pain and 10 being extremely painful, such that higher scores are indicative of increased pain. Assessments will be made both without the back saver pillow - in both the supine position and sitting up with back against another surface, and with the back saver pillow - in both the supine position and sitting up with back against another surface. Results for each combination of pillow set up will be summarized using descriptive statistics.

Other outcomes

  1. Frequency of pillow usage

    Time frame: One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery

    For participants who used the pillow, frequency of pillow usage since it was administered will be summarized using the following ordinal variables: (1) Never (2) Sometimes or (3) All the time. Results will be summarized using descriptive statistics.

Study contacts

Contact information is provided by the study sponsor or research team.

Pamela C Zuckerman, PhD

CONTACT

[email protected]

13479201340

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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