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

NCT04493229 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB00066646
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (10)

• 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)

  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

Secondary Outcomes (6)

• Pain during straight leg raise

  Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery

• Pain after straight leg raise

  Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery

• Physical therapist deems stepping exercise begins; may walk up and down steps

  Post-operative 24-48 hours after surgery

• Gait speed

  Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery

• Average pain score

  Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin IM injection will be given per randomization prior to first outpatient physical therapy session

Drug: Oxytocin

Placebo

ACTIVE COMPARATOR

Placebo IM injection will be given per randomization prior to first outpatient physical therapy session

Drug: Placebo

Interventions

Oxytocin DRUG

IM Oxytocin

Also known as: Pitocin

Oxytocin

Placebo DRUG

Placebo IM

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind study of oxytocin (IM) or placebo given

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 30, 2020
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 2, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)