title: The efficacy of non-surgical treatment on pain and sensitization in patients with knee osteoarthritis: a pre-defined ancillary analysis from a randomized controlled trial.
abstract: OBJECTIVE
  To report the efficacy of a 3-month treatment program consisting of neuromuscular exercise, education, diet, insoles and pain medication (MEDIC-treatment) compared to usual care (two leaflets with information and treatment advice) in reducing pain-related measures and sensitization in patients with knee osteoarthritis (OA) not eligible for total knee replacement (TKR).
  
  
  METHODS
  A pre-defined ancillary analysis of the results at 3 months of a randomized controlled trial (RCT) of 100 patients randomized to MEDIC-treatment or usual care.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT01535001). Outcomes were sensitization assessed at the knee, the lower leg and forearm using a handheld algometer, peak pain intensity in the previous 24 h, pain intensity after 30 min of walking, pain location and pattern, spreading of pain (a region-divided body chart) and the usage of pain medication.
  
  
  RESULTS
  The MEDIC group had larger improvements from baseline to 3 months in peak pain intensity (P = 0.02) and pain after 30 min of walking (P < 0.001) and in the number of body sites with pain (P = 0.04). There was no difference in the change in sensitization from baseline to 3 months between groups (P = 0.87), but sensitization decreased in both groups (P < 0.001).
  
  
  CONCLUSIONS
  A non-surgical treatment program is more efficacious in reducing pain-related measures than usual care, while both are equally efficacious in reducing sensitization, indicating that mechanisms other than pain sensitization contribute to the perceived pain. The patients did not have severe symptomatic knee OA and hence pain sensitization may not yet have developed into a clinically relevant parameter or subgroups with less sensitization may exist.
authors.affiliation: Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, 5230 Odense, Denmark; Clinical Nursing Research Unit, Aalborg University Hospital, 9000 Aalborg, Denmark; Orthopaedic Surgery Research Unit, Aalborg University Hospital, 9000 Aalborg, Denmark; Centre for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark. Electronic address: sots@rn.dk.
authors.forename: S T
authors.initials: ST
authors.lastname: Skou
authors.affiliation: Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, 5230 Odense, Denmark. Electronic address: eroos@health.sdu.dk.
authors.forename: E M
authors.initials: EM
authors.lastname: Roos
authors.affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, 9000 Aalborg, Denmark; Centre for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, 9000 Aalborg, Denmark. Electronic address: ohs@rn.dk.
authors.forename: O
authors.initials: O
authors.lastname: Simonsen
authors.affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, 9000 Aalborg, Denmark; Centre for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, 9000 Aalborg, Denmark. Electronic address: mogens.berg.laursen@rn.dk.
authors.forename: M B
authors.initials: MB
authors.lastname: Laursen
authors.affiliation: Centre for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark. Electronic address: misr@rn.dk.
authors.forename: M S
authors.initials: MS
authors.lastname: Rathleff
authors.affiliation: Centre for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark. Electronic address: LAN@hst.aau.dk.
authors.forename: L
authors.initials: L
authors.lastname: Arendt-Nielsen
authors.affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, 9000 Aalborg, Denmark; Centre for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Faculty of Medicine, Aalborg University, 9220 Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, 9000 Aalborg, Denmark. Electronic address: sten.rasmussen@rn.dk.
authors.forename: S
authors.initials: S
authors.lastname: Rasmussen
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004038:Diet, Reducing; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D061826:Foot Orthoses; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000503:physiopathology / Q000534:rehabilitation*; D059408:Pain Management / Q000379:methods; D010147:Pain Measurement; D017288:Pain Threshold; D010353:Patient Education as Topic; D016037:Single-Blind Method
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; D007052:Ibuprofen
keywords: Clinical trial; Knee; Osteoarthritis; Pain; Sensitization; Therapeutics