OLP to Manage Pain in TJA: A Feasibility Study
Primary Purpose
Opioid Dependence, Opioid Abuse
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Open Label Placebo
Patient medication as standardly prescribed
Sponsored by
About this trial
This is an interventional prevention trial for Opioid Dependence
Eligibility Criteria
Inclusion Criteria:
- Participants eligible to undergo the TJA surgical procedure
Exclusion Criteria:
- Participants who are not eligible to undergo the TJA surgical procedure i.e. (participants who are morbidly obese or with comorbidities that make them ineligible for the surgery)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pain Medication as Standardly Prescribed
Open Label Placebo
Arm Description
Patients will receive pain medication as standardly prescribed. Refills at the 2 week followup will be provided as per the standard treatment protocol.
Initial post-op pain medication will be prescribed. On 2 week followup, refill request will be filled with an open label placebo.
Outcomes
Primary Outcome Measures
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Secondary Outcome Measures
Full Information
NCT ID
NCT04883983
First Posted
April 8, 2021
Last Updated
January 20, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04883983
Brief Title
OLP to Manage Pain in TJA: A Feasibility Study
Official Title
Open Label Placebo to Manage Pain in Total Joint Arthroplasty: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Persistent opioid abuse presents a common yet under-recognized problem given the decreasing rates of morbidity and mortality following common elective surgical procedures, like total joint arthroplasty (TJA). Each year around 33-70% of patients seeking surgical procedures in the U.S. transition to persistent opioid use following elective surgery (such as TJA), primarily prescribed for post-operative pain management. Further, these patients are more likely to demand greater doses and for longer duration post-surgery due to maladaptive neurologic changes occurring in key areas of the brain. The purpose of this study is to see if it is feasible to use OLP (open label placebo) for post-operative pain management in the post TJA setting. In addition the investigators will also collect pilot data to compare key outcome measures (patient reported physical function related to osteoarthritis of the hip and knee, pain score, and health-related quality of life will be assessed) between the placebo and the Treatment-As-Usual (TAU) group over a 90-day post-operative period.
Detailed Description
The investigators will enroll 24 adults that have undergone primary total joint arthroplasty and are requesting additional pain medication at 2 weeks. Once informed, consented and enrolled, participants will be assessed, randomized to either open-label placebo (OLP) or treatment-as-usual (TUA). Participants will be informed on why the OLP may manage the symptoms of postoperative pain and the benefits of OLP vs an Opioid. Patients randomized to OLP will be given placebo pills at their 2 week follow-up appointment (baseline) if additional pain medication is requested. Patients will be instructed to utilize placebo pill in the same manner as their previous medication. If interested, the participant will be consented in clinic and a consent signed in person. Pain control, joint function, and quality of life assessment scores will be conducted at 2, 6, and 12 week follow-up visits in clinic. After randomization, the placebo group will receive a scripted orientation that mimics a typical patient-provider interaction when prescribing a pain medication, including the rationale for effectiveness and the importance of taking the placebo pills as prescribed.
Open-label placebo adherence will be assessed using pill count. The investigators will ask all participants to maintain their current treatment regimens over the course of the study. After 12 weeks, all participants will complete final assessments. Participants in the OLP group will be monitored in clinic to allow for additional pain control if required.
Study outcomes will be measured using SF-36 quality of life score, Visual Analog Scale, Hip disability and Osteoarthritis Outcome Score, and Knee disability and Osteoarthritis Outcome Score. The investigators will also collect information about potential moderators that would include demographic data (e.g., age, years since diagnosis, treatments, gender), use of disease modifying therapies (oral versus infusion), types of medications, total number of medications, history of opioid abuse, history of opioid use, presence of a diagnosed cognitive or psychiatric disorder, mood disorder.
ANCOVA will be used to measure treatment effect with baseline measurement used as a covariate. Effect sizes and estimates of correlation between pre-post measures will be estimated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Opioid Abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pain Medication as Standardly Prescribed
Arm Type
Active Comparator
Arm Description
Patients will receive pain medication as standardly prescribed. Refills at the 2 week followup will be provided as per the standard treatment protocol.
Arm Title
Open Label Placebo
Arm Type
Experimental
Arm Description
Initial post-op pain medication will be prescribed. On 2 week followup, refill request will be filled with an open label placebo.
Intervention Type
Drug
Intervention Name(s)
Open Label Placebo
Intervention Description
Pain medication will be prescribed per standard treatment for initial prescription. Pain medication request at followup will be filled with open label placebo. Pain assessment surveys will be used at 2, 6, and 12 week followups.
Intervention Type
Drug
Intervention Name(s)
Patient medication as standardly prescribed
Intervention Description
Pain medication will be prescribed per standard treatment for initial prescription. On request for additional pain medication, pain medication will be prescribed as per the standard protocol. Pain assessment surveys will be used at 2, 6, and 12 week followups.
Primary Outcome Measure Information:
Title
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Description
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Time Frame
2 weeks (Baseline)
Title
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Description
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Time Frame
6 weeks
Title
Percentage of Patients with acceptable pain control as measured by Visual Analogue scale
Description
VAS is a patient measured scale to evaluate pain, on a scale of 1-10 with 10 being the worst pain.
Time Frame
12 weeks
Title
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time Frame
Week 2 (Baseline)
Title
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time Frame
Week 6
Title
Percentage of Patients with acceptable quality of life as measured by Short Form Health Survey SF-36
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time Frame
Week 12
Title
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Description
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Time Frame
Baseline 2 weeks
Title
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Description
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Time Frame
6 weeks
Title
Percentage of Patients with acceptable joint functionality as measured by knee disability and osteoarthritis outcome score (KOOS)
Description
Knee disability and osteoarthritis outcome score (KOOS) is a patient measured score evaluating Knee function and creates a score out of 100, 100 indicating full functionality.
Time Frame
12 weeks
Title
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Description
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Time Frame
Baseline 2 weeks
Title
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Description
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Time Frame
6 weeks
Title
Percentage of Patients with acceptable joint functionality as measured by hip disability and osteoarthritis outcome score (HOOS).
Description
Hip disability and osteoarthritis outcome score (HOOS) is a patient measured score evaluating Hip function and creates a score out of 100, 100 indicating full functionality.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants eligible to undergo the TJA surgical procedure
Exclusion Criteria:
Participants who are not eligible to undergo the TJA surgical procedure i.e. (participants who are morbidly obese or with comorbidities that make them ineligible for the surgery)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameer Naranje
Phone
(205) 975-2663
Email
snaranje@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Roshan Jacob
Phone
7086556052
Email
roshanjacob@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameer Naranje
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tapan Mehta
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
OLP to Manage Pain in TJA: A Feasibility Study
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