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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Withdrawn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
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiculopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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.
  2. Patient able to provide informed consent

Exclusion Criteria:

  1. Chronic preoperative narcotic use defined as daily narcotic use for the past 6 months prior to surgery
  2. Workers' compensation insurance claim
  3. Active or history of malignancy
  4. 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

    First Posted
    August 3, 2018
    Last Updated
    November 19, 2020
    Sponsor
    Rush University Medical Center
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    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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