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

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.

Study Overview

• Status: Withdrawn
• Conditions: Degenerative Disc Disease; Radiculopathy; Isthmic Spondylolisthesis; Degenerative Spondylolisthesis; Herniated Nucleus Pulposus; Foraminal Stenosis; Central Spinal Stenosis
• Intervention / Treatment: Device: Cold-Therapy System

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).

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Polar Care Kodiak, Breg®
No Intervention: Standard care (ice-pack); Patients will use disposable ice-pack as per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 year postoperative
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.	2 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bony fusion	Postoperative radiographs and CT scan will be used to assess fusion.	2 year postoperative
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.	2 year postoperative
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".	2 year postoperative
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.	2 year postoperative
Length of Stay	The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.	Up to 2 weeks
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.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Pain, Postoperative; Intervertebral Disc Degeneration; Radiculopathy; Constriction, Pathologic; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: 18050401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No