Osteoarthritis, KneePhase 2NCT04493229
A Pilot Feasibility Study of IM OXT on Fear of Pain and Trust in Physical Therapist During OP Rehabilitation After TKA
A Phase 2 study testing Oxytocin in people with Osteoarthritis, Knee, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2024to Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Oxytocin, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
IM Oxytocin
PlaceboDrug
Placebo IM
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Oxytocin IM injection will be given per randomization prior to first outpatient physical therapy session Receives: Drug: Oxytocin |
| Placebo | Active comparator | Placebo IM injection will be given per randomization prior to first outpatient physical therapy session Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication
Secondary outcomes (6)
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.
Measured: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study startJan 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: study team decided not to proceed with project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind study of oxytocin (IM) or placebo given
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James C Eisenach, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493229
- Sponsor's protocol ID
- IRB00066646
- Status last verified
- Jun 2020
- First submitted
- 16 Jul 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04493229
- Acronym / sponsor ID
- IRB00066646
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study team decided not to proceed with project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind study of oxytocin (IM) or placebo given
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinOxytocin IM injection will be given per randomization prior to first outpatient physical therapy session |
| Placebo | Active comparator | Drug: PlaceboPlacebo IM injection will be given per randomization prior to first outpatient physical therapy session |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: PitocinIM Oxytocin | Drug | Oxytocin |
| PlaceboPlacebo IM | Drug | Placebo |
Primary outcome
Tampa Scale of Kinesiophobia-11 (TSK-11)
Time frame: Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline
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)
Time frame: Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication
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)
Time frame: Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication
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)
Time frame: Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication
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)
Time frame: Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication
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)
Time frame: Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline
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)
Time frame: Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication
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)
Time frame: Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication
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)
Time frame: Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication
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)
Time frame: Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication
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.
6 secondary outcomes
Pain during straight leg raise
Time frame: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
Pain after straight leg raise
Time frame: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
Physical therapist deems stepping exercise begins; may walk up and down steps
Time frame: Post-operative 24-48 hours after surgery
Gait speed
Time frame: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
Average pain score
Time frame: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
Analgesic Consumption
Time frame: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Eisenach, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Osteoarthritis, Knee, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Scale of Kinesiophobia-11 (TSK-11) (time frame: Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.