OLP to Manage Pain in TJA: A Feasibility Study

NCT04883983 | Withdrawn Early Phase 1

• 2 other identifiers: IRB-300006920UAB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Dependence; Opioid Abuse

Outcome Measures

Primary Outcomes (12)

• 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.

  2 weeks (Baseline)

• 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.

  6 weeks

• 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.

  12 weeks

• 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.

  Week 2 (Baseline)

• 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.

  Week 6

• 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.

  Week 12

• 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.

  Baseline 2 weeks

• 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.

  6 weeks

• 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.

  12 weeks

• 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.

  Baseline 2 weeks

• 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.

  6 weeks

• 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.

  12 weeks

Study Arms (2)

Pain Medication as Standardly Prescribed

ACTIVE COMPARATOR

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

Drug: Patient medication as standardly prescribed

Open Label Placebo

EXPERIMENTAL

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

Drug: Open Label Placebo

Interventions

Open Label Placebo 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.

Open Label Placebo

Patient medication as standardly prescribed 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.

Pain Medication as Standardly Prescribed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants eligible to undergo the TJA surgical procedure

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sameer Naranje

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Tapan Mehta

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: May 12, 2021
• Study Start: December 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share