Brief Summary
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.
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.
Brief Title
Surgical Recovery Support Pillow for Spine Surgeries
Detailed Description
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
13479201340
Central Contact Email
pcabahugzu@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
SPINE SURGERY COMPLICATIONS
INFECTION
Eligibility Criteria
Inclusion Criteria:
* Adult patients who have lumbar fusion surgery, who consent to participate
Exclusion Criteria:
* Pediatric patients 18 years old and under
* Adult patients who have lumbar fusion surgery, who consent to participate
Exclusion Criteria:
* Pediatric patients 18 years old and under
Inclusion Criteria
Inclusion Criteria:
* Adult patients who have lumbar fusion surgery, who consent to participate
* Adult patients who have lumbar fusion surgery, who consent to participate
Gender
All
Gender Based
false
Keywords
Post-surgical pillow
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
19 Years
NCT Id
NCT07720856
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2026-17746
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Surgical Recovery Support Pillow for Spine Surgeries
Primary Outcomes
Outcome Description
Pillow use will be measured as a dichotomous measure of whether or not the pillow was used. Results will be summarized.
Outcome Measure
Pillow use
Outcome Time Frame
One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery
Outcome Measure
Pillow comfort and pain
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
19
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ananth Eleswarapu
Investigator Email
aeleswarap@montefiore.org
Investigator Department
Orthopaedic Surgery
Investigator Sponsor Organization
Einstein
Study Department
Orthopaedic Surgery
Study Division
Orthopedic Surgery
Categories Mesh Debug
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
MeSH Terms
INFECTIONS