Clavicle Splint for Pain Reduction After Posterior Cervicothoracic Surgery
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of the study is to see whether a clavicle splint can decrease the pain after posterior cervicothoracic surgery. The term "cervicle splint" conveys that the investigators do not deal with clavicle fractures here but use the splint he stabilize the posterior cervical area. The investigators want to demonstrate this in a prospective randomized manner.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 31, 2013
CompletedFirst Posted
Study publicly available on registry
November 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
August 21, 2017
CompletedAugust 21, 2017
July 1, 2017
10 months
October 31, 2013
July 16, 2016
July 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Average Neck Pain Level
Patients self-recorded their average level of pain on a scale from 1 to 10 for each post-surgery day beginning on postoperative day 2. 1 Meaning least pain, 10 meaning worst level of pain
1 month
Study Arms (2)
Standard Management
NO INTERVENTIONPatients wore no brace.
Clavicle Brace Wearing
EXPERIMENTALPatient has to wear clavicle brace for one month.
Interventions
Eligibility Criteria
You may qualify if:
- \- Patient underwent cervicothoracic surgery from posterior -
You may not qualify if:
- \- Patients that are potentially vulnerable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University Hospital
Stanford, California, 94043, United States
Related Publications (1)
Duetzmann S, Cole T, Senft C, Seifert V, Ratliff JK, Park J. Clavicle pain and reduction of incisional and fascial pain after posterior cervical surgery. J Neurosurg Spine. 2015 Dec;23(6):684-9. doi: 10.3171/2015.2.SPINE141118. Epub 2015 Aug 21.
PMID: 26296190DERIVED
Limitations and Caveats
Small number of patients and its location at a single institution.
Results Point of Contact
- Title
- Stephan Duetzmann
- Organization
- Johann Wolfgang Goethe University
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Duetzmann
Stanford University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.,M.Sc.
Study Record Dates
First Submitted
October 31, 2013
First Posted
November 7, 2013
Study Start
October 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
August 21, 2017
Results First Posted
August 21, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share