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Effects of sequential application of local cooling and heating on pain, skin perfusion and wound healing after lumbar decompression

Status Approved

First Submitted Date

2017/11/21
Registered Date

2018/01/18
Last Updated Date

2017/12/28

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002656
Unique Protocol ID	201400000000517
Public/Brief Title	Effects of sequential application of local cooling and heating
Scientific Title	Effects of sequential application of local cooling and heating on pain, skin perfusion and wound healing after lumbar decompression
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2015-0568
Approval Date	2015-06-02
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Yong Soon Shin
Title	Prof
Telephone	+82-2-2220-0798
Affiliation	Hanyang University
Address	School of Nursing, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 133-791, Korea
Contact Person for Public Queries
Name	Yong Soon Shin
Title	Prof
Telephone	+82-2-2220-0798
Affiliation	Hanyang University
Address	School of Nursing, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 133-791, Korea
Contact Person for Updating Information
Name	Yong Soon Shin
Title	Prof
Telephone	+82-2-2220-0798
Affiliation	Hanyang University
Address	School of Nursing, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 133-791, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2015-06-08 Actual
Target Number of Participant	58
Primary Completion Date	2015-12-04 , Actual
Study Completion Date	2016-12-10 , Actual
Name of Study	Asan Medical Center
Recruitment Status	Completed
Date of First Enrollment	2015-06-08 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Hanyang University
Organization Type	University
Project ID	201400000000517

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Hanyang University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Aims of this study was to identify the effects of sequential application of cooling and heating on postoperative pain, skin perfusion, and wound healing following lumbar decompression. This study was designed as a randomized controlled trial using one by one allocation into two groups. Participants were 19 years of age or older and who underwent planned lumbar decompression surgery with diagnosis of lumbar stenosis. Experimental group and control group received cold gel pack application on surgical wound for 15 minutes hourely from 1 hour after the surgery until wound drains were removed(POD 2). Thereafter, patients in experimental group were received local heating using hot pack for 15 minutes hourely until POD 4. Control group did not any thermal stimulation after local cooling was completed. A primary outcome variable was measured 3 times: before intervention, POD 2 (after cooling), and POD 4 (after heating in the experimental group or no thermal stimulation in the control group) and secondary outcomes were measured before the intervention and POD 4. Collected data analyzed using repeated measure ANOVA.

Study Summary Information

Lay Summary

Aims of this study was to identify the effects of sequential application of cooling and heating on postoperative pain, skin perfusion, and wound healing following lumbar decompression. This study was designed as a randomized controlled trial using one by one allocation into two groups. Participants were 19 years of age or older and who underwent planned lumbar decompression surgery with diagnosis of lumbar stenosis. Experimental group and control group received cold gel pack application on surgical wound for 15 minutes hourely from 1 hour after the surgery until wound drains were removed(POD 2). Thereafter, patients in experimental group were received local heating using hot pack for 15 minutes hourely until POD 4. Control group did not any thermal stimulation after local cooling was completed. A primary outcome variable was measured 3 times: before intervention, POD 2 (after cooling), and POD 4 (after heating in the experimental group or no thermal stimulation in the control group) and secondary outcomes were measured before the intervention and POD 4.
Collected data analyzed using repeated measure ANOVA.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Investigator, Outcome Accessor
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	The experimental group and the control group were received cold pack (34162 cm) on the surgical wound for 15 minutes hourly from 1 hour after the surgery to POD 2. This local cooling was not applied during sleeping time (10pm-9am). Thereafter, the experimental group was applied hot pack (34162 cm) on the surgical wound for 15 minutes hourly except for sleeping time (10pm-9am) from POD 3 to POD 4. A cold pack was prepared in a refrigerator for 40 minutes before the local cooling, and a hot pack was heated in a microwave for 2.5 minutes before the local heating. The control group was applied no thermal stimulation after local cooling was completed. A standardized wound dressing with ten piece of long gauze (10*20 cm) and standard postoperative analgesic methods were applied to all patients.
Number of Arms	2
Arm 1	Arm Label Experimental group
	Target Number of Participant 29
	Arm Type Experimental
	Arm Description The experimental group were received cold pack (34162 cm) on the surgical wound for 15 minutes hourly from 1 hour after the surgery to POD 2, thereafter, the experimental group was applied hot pack (34162 cm) on the surgical wound for 15 minutes hourly from POD 3 to POD 4. A cold pack was prepared in a refrigerator for 40 minutes before the local cooling, and a hot pack was heated in a microwave for 2.5 minutes before the local heating. This local cooling or heating was not applied during sleeping time (10pm-9am). A standardized wound dressing with ten piece of long gauze (10*20 cm) and standard postoperative analgesic methods were applied to all patients.
Arm 2	Arm Label Control group
	Target Number of Participant 29
	Arm Type Active comparator
	Arm Description The control group were received cold pack (34162 cm) on the surgical wound for 15 minutes hourly from 1 hour after the surgery to POD 2, A cold pack was prepared in a refrigerator for 40 minutes before the local cooling, however, this local cooling was not applied during sleeping time (10pm-9am).The control group was applied no thermal stimulation after local cooling was completed. A standardized wound dressing with ten piece of long gauze (10*20 cm) and standard postoperative analgesic methods were applied to all patients.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M48.06)Spinal stenosis, lumbar region
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~82Year
	Description Planned lumbar decompression (discectomy, laminectomy) with diagnosis of lumbar stenosis
Exclusion Criteria	Lumbar fusion Cold allergy Unstable vital sign Neurologic instability
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Postoperative pain
Timepoint	Before intervention, POD 2, POD 4
Secondary Outcome(s) 1
Outcome	Skin perfusion
Timepoint	Before intervention, POD 4
Secondary Outcome(s) 2
Outcome	Wound healing
Timepoint	Before intervention, POD 4

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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