OLP to Manage Pain in TJA: A Feasibility Study

NCT ID: NCT04883983

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-10-31

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.

Conditions

Opioid Dependence; Opioid Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pain Medication as Standardly Prescribed

Patients will receive pain medication as standardly prescribed. Refills at the 2 week followup will be provided as per the standard treatment protocol.

Group Type: ACTIVE_COMPARATOR

Patient medication as standardly prescribed

Intervention Type: DRUG

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.

Open Label Placebo

Initial post-op pain medication will be prescribed. On 2 week followup, refill request will be filled with an open label placebo.

Group Type: EXPERIMENTAL

Open Label Placebo

Intervention Type: DRUG

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.

Interventions

Open Label Placebo

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

Patient medication as standardly prescribed

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Tapan Shirish Mehta

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameer Naranje

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Tapan Mehta

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Other Identifiers

UAB

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300006920

Identifier Type: -

Identifier Source: org_study_id