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).
BACKGROUND
Knee 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.


METHODS
One 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.


CONCLUSIONS
These 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.


BACKGROUND
ClinicalTrials.gov Identifier: NCT01638962 (July 3, 2012).
Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark. brclausen@health.sdu.dk.
Brian
B
Clausen
Anders
A
Holsgaard-Larsen
Jens
J
Søndergaard
Robin
R
Christensen
Thomas P
TP
Andriacchi
Ewa M
EM
Roos
D000082:Acetaminophen / Q000627:therapeutic use*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D001696:Biomechanical Phenomena; D002985:Clinical Protocols; D003718:Denmark; D004359:Drug Therapy, Combination; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006304:Health Status; D006801:Humans; D007719:Knee Joint / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D010174:Pamphlets; D010353:Patient Education as Topic; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014741:Video Recording
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen