Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04493229
Status:
WITHDRAWN
Last Update Posted:
2021-06-02
First Post:
2020-07-16
Brief Title:
A Pilot Feasibility Study of IM OXT on Fear of Pain and Trust in Physical Therapist During OP Rehabilitation After TKA
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Pilot Feasibility Study of Intramuscular Oxytocin on Fear of Pain and Trust in Physical Therapist During Outpatient Rehabilitation After Total Knee Arthroplasty
Status:
WITHDRAWN
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study team decided not to proceed with project
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effect that a dose of intramuscular IM oxytocin naturally occurring hormone has on fear of pain and movement and trust in the physical therapist during outpatient rehabilitation after total knee replacement has been performed Investigators will ask participants to answer questions about fear of pain and movement before several outpatient physical therapy session and investigators will ask participants questions about trust of the physical therapist several times after the outpatient physical therapy sessions
Detailed Description:
The purpose of this study is to determine feasibility of this study design and identify barriers that altered design could bring to overcome these barriers in the design of a large pragmatic multi-center clinical trial It is also designed to estimate the effect size and variance of the main outcome measures trust and fear in patients undergoing rehabilitation after total knee arthroplasty TKA The study team hypothesizes that intramuscular IM oxytocin in a dose and time determined by a series of previous studies under this grant to target the brain will enhance trust and reduce fear and that these will be associated with improved outcomes Again the study is not designed to test this hypothesis but to gather the critical data necessary to test it in a large multi-center clinical trial that would follow this grant
Participants that have decided to undergo unilateral TKA will come to the Pain Clinical Research Unit at least 48 hours prior to surgery to confirm consent and complete a series of questionnaires Participants surgery anesthesia and postoperative medication and therapy treatment will be routine On the first outpatient study visit participants will complete a questionnaire of fear about pain and receive an intramuscular injection of oxytocin or placebo in a randomized double blind manner At the end of this session participants will complete a questionnaire assessing the degree of trust in the therapist Physical therapy be will routine and the fear and trust questionnaires will be completed at the 2nd 4th 8th and last physical therapy session as well as routine measures of progress and function The primary outcome measure is assessment of effect size and variability of the trust and fear questionnaires on the 1st and 2nd visit
Participants that have decided to undergo unilateral TKA will come to the Pain Clinical Research Unit at least 48 hours prior to surgery to confirm consent and complete a series of questionnaires Participants surgery anesthesia and postoperative medication and therapy treatment will be routine On the first outpatient study visit participants will complete a questionnaire of fear about pain and receive an intramuscular injection of oxytocin or placebo in a randomized double blind manner At the end of this session participants will complete a questionnaire assessing the degree of trust in the therapist Physical therapy be will routine and the fear and trust questionnaires will be completed at the 2nd 4th 8th and last physical therapy session as well as routine measures of progress and function The primary outcome measure is assessment of effect size and variability of the trust and fear questionnaires on the 1st and 2nd visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None