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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | Oxytocin IM injection will be given per randomization prior to first outpatient physical therapy session |
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| Placebo | Active Comparator | Placebo IM injection will be given per randomization prior to first outpatient physical therapy session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | IM Oxytocin |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline |
| 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 | Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication |
| 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 | Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication |
| 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 | Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication |
| 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 | Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication |
| Working Alliance Inventory (WAI) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James C Eisenach, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Randomized, double-blind study of oxytocin (IM) or placebo given
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| Placebo |
| Drug |
Placebo IM |
|
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. |
| Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline |
| 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. | Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication |
| 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. | Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication |
| 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. | Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication |
| 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. | Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication |
| 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. | Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery |
| 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. | Post-operative 24-48 hours after surgery |
| 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. | Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery |
| 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. | Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery |
| 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. | Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery |
| D012216 |
| Rheumatic Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |