Abstract
BackgroundKnee osteoarthritis (OA) is prevalent and often associated with meniscal tear. Physical therapy (PT) and exercise regimens are often used to treat OA or meniscal tear, but, to date, few programs have been designed specifically for conservative treatment of meniscal tear with concomitant knee OA. Clinical care and research would be enhanced by a standardized, evidence–based, conservative treatment program and the ability to study the effects of the contextual factors associated with interventions for patients with painful, degenerative meniscal tears in the setting of OA. This paper describes the process of developing both a PT intervention and a home exercise program for a randomized controlled clinical trial that will compare the effectiveness of these interventions for patients with knee pain, meniscal tear and concomitant OA.MethodsThis paper describes the process utilized by an interdisciplinary team of physical therapists, physicians, and researchers to develop and refine a standardized in-clinic PT intervention, and a standardized home exercise program to be carried out without PT supervision. The process was guided in part by Medical Research Council guidance on intervention development.ResultsThe investigators achieved agreement on an in-clinic PT intervention that included manual therapy, stretching, strengthening, and neuromuscular functional training addressing major impairments in range of motion, musculotendinous length, muscle strength and neuromotor control in the major muscle groups associated with improving knee function. The investigators additionally achieved agreement on a progressive, protocol-based home exercise program (HEP) that addressed the same major muscle groups. The HEP was designed to allow patients to perform and progress the exercises without PT supervision, utilizing minimal equipment and a variety of methods for instruction.DiscussionThis multi-faceted in-clinic PT program and standardized HEP provide templates for in-clinic and home-based care for patients with symptomatic degenerative meniscal tear and concomitant OA. These interventions will be tested as part of the Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial.Trial registrationThe TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 on February 14, 2017. TeMPO was also approved by the Institutional Review Board at Partners HealthCare/Brigham and Women’s Hospital.
Highlights
Design overview The development of the Treatment of Meniscal Tear in Osteoarthritis (TeMPO) in-clinic and home exercise program (HEP) programs consisted of six phases
This paper reports our process for developing an inclinic Physical therapy (PT) intervention and a self-administered home exercise program (HEP) for the TeMPO Trial using a dual approach of best available published evidence and clinician experience in our field of interest
The PT interventions in these trials were developed rigorously and shown to reduce pain in this patient population. These trials demonstrated that subjects assigned to PT-based treatment improved in pain scores by ~ 1 standard deviation (Table 1). These Randomized Controlled Trial (RCT) acted as a starting point for the TeMPO PT regimen [10, 15, 22–30]
Summary
Design overview The development of the TeMPO in-clinic and HEP programs consisted of six phases. A core group of physical therapists, physicians and research methodologists invited a group of physical therapists from four academic US centers to form an expert panel that would guide the creation of both TeMPO programs This group communicated extensively on conference phone calls and attended in person meetings throughout the trial development. The initial expert panel was expanded to add more orthopaedic surgeons, rheumatologists, researchers and physical therapists from the four study sites to form the trial research team This expanded panel participated in a series of conference calls and two in person meetings to develop, review, and revise the components of the TeMPO program. Understanding which elements of a PT intervention, or home exercise program are most effective for patients with meniscal tear and concomitant OA, and the role of contextual factors in treatment outcomes, remains an important research gap
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