Back to resultsA Pilot Feasibility Study of IM OXT on Fear of Pain and Trust in Physical Therapist During OP Rehabilitation After TKA
Primary Purpose
Osteoarthritis, Knee
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.
- Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1, 2, or 3. Scheduled for unilateral TKA and postoperative physical therapy at Davie Medical Center.
- Normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication or for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.
- Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
Exclusion Criteria:
- Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
- Women who are pregnant (positive result for urine pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years
- Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
Sites / Locations
- Wake Forest Baptist Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oxytocin
Placebo
Arm Description
Oxytocin IM injection will be given per randomization prior to first outpatient physical therapy session
Placebo IM injection will be given per randomization prior to first outpatient physical therapy session
Outcomes
Primary Outcome Measures
Tampa Scale of Kinesiophobia-11 (TSK-11)
TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
Tampa Scale of Kinesiophobia-11 (TSK-11)
TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
Tampa Scale of Kinesiophobia-11 (TSK-11)
TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
Tampa Scale of Kinesiophobia-11 (TSK-11)
TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
Tampa Scale of Kinesiophobia-11 (TSK-11)
TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
Working Alliance Inventory (WAI)
The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
Working Alliance Inventory (WAI)
The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
Working Alliance Inventory (WAI)
The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
Working Alliance Inventory (WAI)
The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
Working Alliance Inventory (WAI)
The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
Secondary Outcome Measures
Pain during straight leg raise
During the postoperative physical therapy sessions, pain using a 0-10 verbal scale, with 0 equivalent to NO PAIN and 10 equivalent to THE WORST PAIN IMAGINABLE will be measured and the data collected from the electronic medical record.
Pain after straight leg raise
During the postoperative physical therapy sessions, pain using a 0-10 verbal scale, with 0 equivalent to NO PAIN and 10 equivalent to THE WORST PAIN IMAGINABLE will be measured and the data collected from the electronic medical record.
Physical therapist deems stepping exercise begins; may walk up and down steps
During routine physical therapy after this surgery, the therapist determines when the patient is ready to begin stepping exercised during therapy. It is a subjective determination by the therapist. The outcome measure is the number of days since surgery when the therapist notes in the electronic medical record (EMR) that the patient began stepping exercises.
Gait speed
Gait speed will be measured by the physical therapist at the first physical therapy session and the last physical therapy session and at varying times during physical therapy after surgery using meters/seconds. Distance in meters is divided by the number of seconds.
This data will be recorded in the electronic medical recorded and recorded from the electronic medical record.
Average pain score
Patients will be asked to verbally state the average pain they have experienced in the 24 hours prior to the scheduled physical therapy session. Average pain will be measured using a verbal pain scale; 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE.
Analgesic Consumption
Analgesic medications will be recorded from the day previous to each therapy session. Analgesic consumption will be converted into morphine equivalents using a standard conversion table.
Full Information
NCT ID
NCT04493229
First Posted
July 16, 2020
Last Updated
May 27, 2021
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04493229
Brief Title
A Pilot Feasibility Study of IM OXT on Fear of Pain and Trust in Physical Therapist During OP Rehabilitation After TKA
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
study team decided not to proceed with project
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind study of oxytocin (IM) or placebo given
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Oxytocin IM injection will be given per randomization prior to first outpatient physical therapy session
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Placebo IM injection will be given per randomization prior to first outpatient physical therapy session
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
IM Oxytocin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo IM
Primary Outcome Measure Information:
Title
Tampa Scale of Kinesiophobia-11 (TSK-11)
Description
TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
Time Frame
Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline
Title
Tampa Scale of Kinesiophobia-11 (TSK-11)
Description
TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
Time Frame
Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication
Title
Tampa Scale of Kinesiophobia-11 (TSK-11)
Description
TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
Time Frame
Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication
Title
Tampa Scale of Kinesiophobia-11 (TSK-11)
Description
TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
Time Frame
Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication
Title
Tampa Scale of Kinesiophobia-11 (TSK-11)
Description
TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
Time Frame
Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication
Title
Working Alliance Inventory (WAI)
Description
The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
Time Frame
Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline
Title
Working Alliance Inventory (WAI)
Description
The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
Time Frame
Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication
Title
Working Alliance Inventory (WAI)
Description
The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
Time Frame
Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication
Title
Working Alliance Inventory (WAI)
Description
The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
Time Frame
Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication
Title
Working Alliance Inventory (WAI)
Description
The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
Time Frame
Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication
Secondary Outcome Measure Information:
Title
Pain during straight leg raise
Description
During the postoperative physical therapy sessions, pain using a 0-10 verbal scale, with 0 equivalent to NO PAIN and 10 equivalent to THE WORST PAIN IMAGINABLE will be measured and the data collected from the electronic medical record.
Time Frame
Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
Title
Pain after straight leg raise
Description
During the postoperative physical therapy sessions, pain using a 0-10 verbal scale, with 0 equivalent to NO PAIN and 10 equivalent to THE WORST PAIN IMAGINABLE will be measured and the data collected from the electronic medical record.
Time Frame
Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
Title
Physical therapist deems stepping exercise begins; may walk up and down steps
Description
During routine physical therapy after this surgery, the therapist determines when the patient is ready to begin stepping exercised during therapy. It is a subjective determination by the therapist. The outcome measure is the number of days since surgery when the therapist notes in the electronic medical record (EMR) that the patient began stepping exercises.
Time Frame
Post-operative 24-48 hours after surgery
Title
Gait speed
Description
Gait speed will be measured by the physical therapist at the first physical therapy session and the last physical therapy session and at varying times during physical therapy after surgery using meters/seconds. Distance in meters is divided by the number of seconds.
This data will be recorded in the electronic medical recorded and recorded from the electronic medical record.
Time Frame
Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
Title
Average pain score
Description
Patients will be asked to verbally state the average pain they have experienced in the 24 hours prior to the scheduled physical therapy session. Average pain will be measured using a verbal pain scale; 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE.
Time Frame
Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
Title
Analgesic Consumption
Description
Analgesic medications will be recorded from the day previous to each therapy session. Analgesic consumption will be converted into morphine equivalents using a standard conversion table.
Time Frame
Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female > 18 and < 75 years of age, Body Mass Index (BMI) <40.
Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1, 2, or 3. Scheduled for unilateral TKA and postoperative physical therapy at Davie Medical Center.
Normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication or for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute.
Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.
Exclusion Criteria:
Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
Women who are pregnant (positive result for urine pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years
Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James C Eisenach, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Feasibility Study of IM OXT on Fear of Pain and Trust in Physical Therapist During OP Rehabilitation After TKA
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