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The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion

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ClinicalTrials.gov Identifier: NCT03640338
Recruitment Status : Withdrawn (Limiting funding sources forced us to withdraw the study.)
First Posted : August 21, 2018
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Radiculopathy Central Spinal Stenosis Foraminal Stenosis Herniated Nucleus Pulposus Degenerative Disc Disease Isthmic Spondylolisthesis Degenerative Spondylolisthesis Device: Cold-Therapy System Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Cold-therapy system
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.
Device: Cold-Therapy System
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.
Other Name: Polar Care Kodiak, Breg®

No Intervention: Standard care (ice-pack)
Patients will use disposable ice-pack as per standard of care



Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: 2 year postoperative ]

    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.


  2. Narcotics Consumption [ Time Frame: 2 weeks postoperative ]
    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 :
  1. Bony fusion [ Time Frame: 2 year postoperative ]
    Postoperative radiographs and CT scan will be used to assess fusion.

  2. Disability [ Time Frame: 2 year postoperative ]

    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.


  3. Physical Function: Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 2 year postoperative ]

    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".


  4. General Health Status: Short-Form (SF-12) [ Time Frame: 2 year postoperative ]

    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.


  5. Length of Stay [ Time Frame: Up to 2 weeks ]
    The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.

  6. Disposition on discharge [ Time Frame: Up to 2 weeks ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640338


Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Kern Singh, MD Rush University Medical Center
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03640338    
Other Study ID Numbers: 18050401
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Radiculopathy
Constriction, Pathologic
Pain, Postoperative
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spondylolysis
Spondylosis