The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion
Primary Purpose
Radiculopathy, Central Spinal Stenosis, Foraminal Stenosis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cold-Therapy System
Sponsored by
About this trial
This is an interventional prevention trial for Radiculopathy
Eligibility Criteria
Inclusion Criteria:
- Single or multi-level lumbar spinal fusion for degenerative pathology, including: radiculopathy, central spinal stenosis, foraminal stenosis, herniated nucleus pulposus, degenerative disc disease, and isthmic or degenerative spondylolisthesis.
- Patient able to provide informed consent
Exclusion Criteria:
- Chronic preoperative narcotic use defined as daily narcotic use for the past 6 months prior to surgery
- Workers' compensation insurance claim
- Active or history of malignancy
- Unable to speak, read, or comprehend English language
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cold-therapy system
Standard care (ice-pack)
Arm Description
Patients will receive a cold-therapy system postoperatively (Polar Care Kodiak, Breg®) and will use the system during inpatient stay and during the first 14 days post-discharge.
Patients will use disposable ice-pack as per standard of care
Outcomes
Primary Outcome Measures
Postoperative Pain
Average daily Visual Analog Scale (VAS) survey, which measures pain, for the duration of hospital stay and postoperative VAS scores will be recorded for 2 years postoperatively. This information will be collected through a survey that will be administered upon patient discharge. Patients will be asked to return the completed survey to the research team.
VAS scale ranges from 0 - 100 mm, with 100 representing maximum pain and 0 representing no pain.
Narcotics Consumption
Total, daily, and hourly narcotics consumption during the hospitalization. Narcotic consumption will be recorded for 2 weeks following discharge. Patients will be asked to report the number of narcotic pills taken each day. This information will be collected through a survey that will be administered upon patient discharge. Patients will be asked to return the completed survey to the research team.
Secondary Outcome Measures
Bony fusion
Postoperative radiographs and CT scan will be used to assess fusion.
Disability
Postoperative Oswestry Disability Index (ODI) survey scores will be compared to preoperative values.
ODI measures disability for lumbar patients. The scale ranges from 0% to 100%. 0-20% represents minimal disability, 21-40% represents moderate disability, 41-60% represents severe disability, 61%-80% represents a crippled state, and 81-100% represents a bed-bound patient.
Physical Function: Patient-Reported Outcomes Measurement Information System (PROMIS)
Postoperative PROMIS scores will be compared to preoperative values.
PROMIS evaluates physical function through a series of questions covering level of difficulty with normal daily activities. A score of 5 represents "without any difficulty" and a score of 1 represents "unable to do".
General Health Status: Short-Form (SF-12)
Postoperative SF-12 scores will be compared to preoperative values.
SF-12 evaluates the general health status of the patient. A minimum score of 0 represents the lowest level of health, while a maximum score of 100 represents the highest level of health.
Length of Stay
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.
Disposition on discharge
This outcome evaluates where the patient will return to after their inpatient stay. This could include, but is not limited to, their home, a rehabilitation facility, or a skilled nursing facility.
Full Information
NCT ID
NCT03640338
First Posted
August 3, 2018
Last Updated
November 19, 2020
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03640338
Brief Title
The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion
Official Title
The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Limiting funding sources forced us to withdraw the study.
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patient outcomes and satisfaction are an ever-increasing priority in surgical specialties. Cryotherapy has been utilized following spine surgery as an adjunct therapy to reduce postoperative inflammation and improve patient outcomes. However, limited studies have investigated the effect of cryotherapy on postoperative pain and narcotics use. Fountas et al. performed a randomized controlled trial to assess the impact of postoperative cryotherapy following single-level lumbar microdiscectomy. The authors reported patients receiving cryotherapy required significantly less pain medication (0.058 mg/kg/hr versus 0.067 mg/kg/hr, p<0.001) and had shorter hospital stays (1.71 days versus 2.65 days, p<0.001) as compared to the control group. In another randomized trial of single-level lumbar discectomy patients, Murata et al. demonstrated cryotherapy to have no significant effect on VAS inpatient pain scores or postoperative blood loss.
Detailed Description
The purpose of this study is to determine if postoperative cryotherapy with a cold-therapy system reduces postoperative pain and narcotic consumption following single and multi-level spinal fusion.
The investigators hypothesize that patients undergoing lumbar spinal fusion who receive postoperative cryotherapy treatment with a cold-therapy system will have reduced inpatient pain scores and require less narcotics as compared to patients that receive standard care (ice pack).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy, Central Spinal Stenosis, Foraminal Stenosis, Herniated Nucleus Pulposus, Degenerative Disc Disease, Isthmic Spondylolisthesis, Degenerative Spondylolisthesis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cold-therapy system
Arm Type
Experimental
Arm Description
Patients will receive a cold-therapy system postoperatively (Polar Care Kodiak, Breg®) and will use the system during inpatient stay and during the first 14 days post-discharge.
Arm Title
Standard care (ice-pack)
Arm Type
No Intervention
Arm Description
Patients will use disposable ice-pack as per standard of care
Intervention Type
Device
Intervention Name(s)
Cold-Therapy System
Other Intervention Name(s)
Polar Care Kodiak, Breg®
Intervention Description
After surgery, participants assigned to this group will receive the cold-therapy system to use at the hospital and during the first 2 weeks following discharge.
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Average daily Visual Analog Scale (VAS) survey, which measures pain, for the duration of hospital stay and postoperative VAS scores will be recorded for 2 years postoperatively. This information will be collected through a survey that will be administered upon patient discharge. Patients will be asked to return the completed survey to the research team.
VAS scale ranges from 0 - 100 mm, with 100 representing maximum pain and 0 representing no pain.
Time Frame
2 year postoperative
Title
Narcotics Consumption
Description
Total, daily, and hourly narcotics consumption during the hospitalization. Narcotic consumption will be recorded for 2 weeks following discharge. Patients will be asked to report the number of narcotic pills taken each day. This information will be collected through a survey that will be administered upon patient discharge. Patients will be asked to return the completed survey to the research team.
Time Frame
2 weeks postoperative
Secondary Outcome Measure Information:
Title
Bony fusion
Description
Postoperative radiographs and CT scan will be used to assess fusion.
Time Frame
2 year postoperative
Title
Disability
Description
Postoperative Oswestry Disability Index (ODI) survey scores will be compared to preoperative values.
ODI measures disability for lumbar patients. The scale ranges from 0% to 100%. 0-20% represents minimal disability, 21-40% represents moderate disability, 41-60% represents severe disability, 61%-80% represents a crippled state, and 81-100% represents a bed-bound patient.
Time Frame
2 year postoperative
Title
Physical Function: Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
Postoperative PROMIS scores will be compared to preoperative values.
PROMIS evaluates physical function through a series of questions covering level of difficulty with normal daily activities. A score of 5 represents "without any difficulty" and a score of 1 represents "unable to do".
Time Frame
2 year postoperative
Title
General Health Status: Short-Form (SF-12)
Description
Postoperative SF-12 scores will be compared to preoperative values.
SF-12 evaluates the general health status of the patient. A minimum score of 0 represents the lowest level of health, while a maximum score of 100 represents the highest level of health.
Time Frame
2 year postoperative
Title
Length of Stay
Description
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.
Time Frame
Up to 2 weeks
Title
Disposition on discharge
Description
This outcome evaluates where the patient will return to after their inpatient stay. This could include, but is not limited to, their home, a rehabilitation facility, or a skilled nursing facility.
Time Frame
Up to 2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Single or multi-level lumbar spinal fusion for degenerative pathology, including: radiculopathy, central spinal stenosis, foraminal stenosis, herniated nucleus pulposus, degenerative disc disease, and isthmic or degenerative spondylolisthesis.
Patient able to provide informed consent
Exclusion Criteria:
Chronic preoperative narcotic use defined as daily narcotic use for the past 6 months prior to surgery
Workers' compensation insurance claim
Active or history of malignancy
Unable to speak, read, or comprehend English language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kern Singh, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion
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