The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial)

Abstract

BackgroundKnee osteoarthritis (OA) is a mechanically driven disease, and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief, indicating that pharmacologic pain relief may be positively associated with disease progression. Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable. The knee-joint load is influenced by functional alignment of the trunk, pelvis, and lower-limb segments with respect to the knee, as well as the ground-reaction force generated during movement. Neuromuscular exercise can influence knee load and decrease knee pain. It includes exercises to improve balance, muscle activation, functional alignment, and functional knee stability. The primary objective of this randomized controlled trial (RCT) is to investigate the efficacy of a NEuroMuscular EXercise (NEMEX) therapy program, compared with optimized analgesics and antiinflammatory drug use, on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis.Method/DesignOne hundred men and women with mild to moderate medial knee osteoarthritis will be recruited from general medical practices and randomly allocated (1:1) to one of two 8-week treatments, either (a) NEMEX therapy twice a week or (b) information on the recommended use of analgesics and antiinflammatory drugs (acetaminophen and oral NSAIDs) via a pamphlet and video materials. The primary outcome is change in knee load during walking (the Knee Index, a composite score of the first external peak total reaction moment on the knee joint from all three planes based on 3D movement analysis) after 8 weeks of intervention. Secondary outcomes include changes in the external peak knee-adduction moment and impulse and functional performance measures, in addition to changes in self-reported pain, function, health status, and quality of life.DiscussionThese findings will help determine whether 8 weeks of neuromuscular exercise is superior to optimized use of analgesics and antiinflammatory drugs regarding knee-joint load, pain and physical function in people with mild to moderate knee osteoarthritis.Trial registrationClinicalTrials.gov Identifier: NCT01638962 (July 3, 2012).

Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement

“…Online supplementary appendices provided with comprehensive text descriptions and photographs or videos for each exercise26 44 45…”

Aerobic exercise training and low-level laser therapy modulate inflammatory response and degenerative process in an experimental model of knee osteoarthritis in rats

“…In this context, experimental and clinical studies have investigated the effects of physical exercise training and electrophysical treatments, such as LLLT, on osteoarthritic cartilage tissue 20e23 . Several authors have suggested that exercises such as joint-specific strength and general aerobic conditioning are effective for OA treatment 10,14,15 . Moreover, some authors demonstrated that LLLT was able of decreasing the level of cartilage damage and producing a better tissue structure, biomodulating the inflammatory process and reducing swelling 2,27,29,30 .…”

“…More recently, more innovative therapeutic approaches have been developed, aiming to avoid and to reduce joint damage and, consequently, the minimization of the functional restrictions in affected joint is of extreme clinical importance 7 . Among the innumerable range of therapeutic interventions, the positive effects of physical exercise programs on cartilage metabolism can be highlighted 8,9 . Physical exercise focusing on muscle strengthening or on aerobic activity, is an effective, low-cost and accessible therapeutic modality and might play a crucial role in the prevention and treatment of OA 4,10,11 . It is well established that regular physical exercise can improve function and reduce pain and muscle fatigue 10e13 .…”

An 8-Week Neuromuscular Exercise Program for Patients With Mild to Moderate Knee Osteoarthritis: A Case Series Drawn From a Registered Clinical Trial

“…The full list of inclusion and exclusion criteria is available from the published study protocol. 7 All participants provided written informed consent, and the study was approved by the regional Committee for Medical Research Ethics (project-ID: S-20110153) and the Danish Data Protection Agency (journal-ID: 2011-41-7045).…”

“…However, a detailed NEMEX treatment strategy for patients with mild to moderate KOA has not been described except in the protocol paper of our study. 7 The primary aims of the NEMEX program, to improve sensorimotor control and functional joint stabilization (ie, quality of movement), differ from those of traditional osteoarthritis programs, which have a main goal of improving cardiovascular output (ie, walking programs) or enhancing muscle strength (ie, strength training with machines). 3,8 The NEMEX-KOA program that we describe was designed for physically active, middle-aged patients with mild to moderate KOA; therefore, it involves exercises and difficulty levels that are more challenging than in the previously described NEMEX program for total joint replacement.…”