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A Pilot Feasibility Study of IM OXT on Fear of Pain and Trust in Physical Therapist During OP Rehabilitation After TKA

NCT04493229 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-06-02

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Oxytocin

IM Oxytocin

DRUG

Placebo

Placebo IM

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • James C Eisenach, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04493229 on ClinicalTrials.gov