A Sequenced Strategy for Improving Outcomes in People With Knee

Status Recruiting

Clinical Trial Summary

There is an urgent public health need to reduce reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA.These results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-surgical alternatives.

Clinical Trial Description

Knee osteoarthritis (KOA) is one of the leading causes of chronic pain and disability worldwide, affecting over 30% of older adults. It represents a major global health and economic burden to individuals and society. The rates of KOA have more than doubled in the past 70 years and continue to grow sharply, given increases in life expectancy and population body mass index (BMI). Surgery is often employed to treat KOA, but it is associated with a high rate of persistent pain, and is not a permanent solution. Numerous nonsurgical therapies have been advocated to treat pain in patients with KOA yet are not often used in clinical care. The limited pain relief and functional improvement seen in a subset of knee OA sufferers has led to a high rate of opioid use and disability in this population. The overarching goal of this study is to conduct a sequential parallel group randomized controlled trial (RCT) to evaluate the comparative effectiveness of conservative behavioral and non-opioid pharmacological treatments (Phase 1) and, among those that indicate interest in obtaining further treatment and those not eligible for conservative treatment, the benefits of procedural interventions (Phase 2). This study will also evaluate whether clinical and psychosocial phenotypes predict short- and longer-term treatment response. The results of this study will examine the effectiveness of each tested intervention and provide meaningful information regarding effectiveness across key subgroups of participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04504812
Study type	Interventional
Source	Johns Hopkins University
Contact	Claudia Campbell, PhD
Phone	410-550-7906
Email	ccampb41@jhmi.edu
Status	Recruiting
Phase	Phase 3
Start date	February 1, 2021
Completion date	March 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04651673` - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed	`NCT05677399` - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.	N/A
Active, not recruiting	`NCT04043819` - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis	Phase 1
Recruiting	`NCT06000410` - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee	Phase 3
Completed	`NCT05014542` - Needling Techniques for Knee Osteoarthritis	N/A
Recruiting	`NCT05892133` - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty	N/A
Recruiting	`NCT05528965` - Parallel Versus Perpendicular Technique for Genicular Radiofrequency	N/A
Active, not recruiting	`NCT03472300` - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting	`NCT02003976` - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone	N/A
Active, not recruiting	`NCT04017533` - Stability of Uncemented Medially Stabilized TKA	N/A
Completed	`NCT04779164` - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis	N/A
Recruiting	`NCT04006314` - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis	N/A
Recruiting	`NCT05423587` - Genicular Artery Embolisation for Knee Osteoarthritis II	N/A
Enrolling by invitation	`NCT04145401` - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting	`NCT03781843` - Effects of Genicular Nerve Block in Knee Osteoarthritis	N/A
Completed	`NCT05974501` - Pre vs Post Block in Total Knee Arthroplasty (TKA)	Phase 4
Completed	`NCT05324163` - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis	Phase 3
Completed	`NCT05529914` - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis	N/A
Recruiting	`NCT05693493` - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?	N/A
Not yet recruiting	`NCT05510648` - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain — SKOAP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms