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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

Studies

Study First Submitted Date 2020-07-16
Study First Posted Date 2020-07-30
Last Update Posted Date 2021-06-02
Start Month Year January 2024
Primary Completion Month Year January 2026
Verification Month Year June 2020
Verification Date 2020-06-30
Last Update Posted Date 2021-06-02

Detailed Descriptions

Sequence: 20778894
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.

Facilities

Sequence: 200577717
Name Wake Forest Baptist Health
City Winston-Salem
State North Carolina
Zip 27157
Country United States

Browse Interventions

Sequence: 96281207 Sequence: 96281208 Sequence: 96281209 Sequence: 96281210
Mesh Term Oxytocin Mesh Term Oxytocics Mesh Term Reproductive Control Agents Mesh Term Physiological Effects of Drugs
Downcase Mesh Term oxytocin Downcase Mesh Term oxytocics Downcase Mesh Term reproductive control agents Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52317592
Name Osteoarthritis, Knee
Downcase Name osteoarthritis, knee

Id Information

Sequence: 40263347
Id Source org_study_id
Id Value IRB00066646

Countries

Sequence: 42682588
Name United States
Removed False

Design Groups

Sequence: 55756325 Sequence: 55756326
Group Type Experimental Group Type Active Comparator
Title Oxytocin Title Placebo
Description Oxytocin IM injection will be given per randomization prior to first outpatient physical therapy session Description Placebo IM injection will be given per randomization prior to first outpatient physical therapy session

Interventions

Sequence: 52628702 Sequence: 52628703
Intervention Type Drug Intervention Type Drug
Name Oxytocin Name Placebo
Description IM Oxytocin Description Placebo IM

Design Outcomes

Sequence: 177919766 Sequence: 177919767 Sequence: 177919768 Sequence: 177919769 Sequence: 177919770 Sequence: 177919771 Sequence: 177919772 Sequence: 177919773 Sequence: 177919774 Sequence: 177919775 Sequence: 177919776 Sequence: 177919777 Sequence: 177919778 Sequence: 177919779 Sequence: 177919780 Sequence: 177919781
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Tampa Scale of Kinesiophobia-11 (TSK-11) Measure Tampa Scale of Kinesiophobia-11 (TSK-11) Measure Tampa Scale of Kinesiophobia-11 (TSK-11) Measure Tampa Scale of Kinesiophobia-11 (TSK-11) Measure Tampa Scale of Kinesiophobia-11 (TSK-11) Measure Working Alliance Inventory (WAI) Measure Working Alliance Inventory (WAI) Measure Working Alliance Inventory (WAI) Measure Working Alliance Inventory (WAI) Measure Working Alliance Inventory (WAI) Measure Pain during straight leg raise Measure Pain after straight leg raise Measure Physical therapist deems stepping exercise begins; may walk up and down steps Measure Gait speed Measure Average pain score Measure Analgesic Consumption
Time Frame Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline Time Frame Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication Time Frame Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication Time Frame Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication Time Frame Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication Time Frame Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline Time Frame Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication Time Frame Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication Time Frame Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication Time Frame Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication Time Frame Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery Time Frame Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery Time Frame Post-operative 24-48 hours after surgery Time Frame Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery Time Frame Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery Time Frame Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
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 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 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 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 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 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.

Browse Conditions

Sequence: 194044147 Sequence: 194044148 Sequence: 194044149 Sequence: 194044150 Sequence: 194044151 Sequence: 194044152
Mesh Term Osteoarthritis, Knee Mesh Term Osteoarthritis Mesh Term Arthritis Mesh Term Joint Diseases Mesh Term Musculoskeletal Diseases Mesh Term Rheumatic Diseases
Downcase Mesh Term osteoarthritis, knee Downcase Mesh Term osteoarthritis Downcase Mesh Term arthritis Downcase Mesh Term joint diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term rheumatic diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48456392
Agency Class OTHER
Lead Or Collaborator lead
Name Wake Forest University Health Sciences

Overall Officials

Sequence: 29363381
Role Principal Investigator
Name James C Eisenach, MD
Affiliation Wake Forest University Health Sciences

Design Group Interventions

Sequence: 68346439 Sequence: 68346440
Design Group Id 55756325 Design Group Id 55756326
Intervention Id 52628702 Intervention Id 52628703

Eligibilities

Sequence: 30850209
Gender All
Minimum Age 18 Years
Maximum Age 75 Years
Healthy Volunteers No
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.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254264615
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 75
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 10
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30596067
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Basic Science
Time Perspective
Masking Triple
Intervention Model Description Randomized, double-blind study of oxytocin (IM) or placebo given
Subject Masked True
Investigator Masked True
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26739989
Intervention Id 52628702
Name Pitocin

Responsible Parties

Sequence: 28962545
Responsible Party Type Sponsor