title: Patients' perception of Parkinson's disease-associated pain following initiation of rotigotine: a multicenter non-interventional study.
abstract: OBJECTIVE
  To evaluate Parkinson's disease (PD)-associated pain as perceived by the patients (subjective characterization), and how this may change following initiation of rotigotine transdermal patch.
  
  
  METHODS
  SP1058 was a non-interventional study conducted in routine clinical practice in Germany and Austria in patients experiencing PD-associated pain (per the physician's assessment). Data were collected at baseline (ie, before rotigotine initiation) and at a routine visit after ≥25 days (-3 days allowed) of treatment on a maintenance dose of rotigotine (end of study [EoS]). Pain perception was assessed using the 12-item Pain Description List of the validated German Pain Questionnaire (each item ranked 0 = 'not true' to 3 = 'very true'). Primary effectiveness variable: change from baseline to EoS in the sum score of the 4 'affective dimension' items of the Pain Description List. Secondary effectiveness variables: change from baseline to EoS in Unified Parkinson's Disease Rating Scale (UPDRS) II, III, and II+III scores, and Parkinson's Disease Questionnaire (PDQ-8) total score (PD-related quality-of-life). Other variables included scores of the eight 'sensory dimension' items of the Pain Description List.
  
  
  RESULTS
  Of 93 enrolled patients (mean [SD] age: 71.1 [9.0] years; male: 48 [52%]), 77 (83%) completed the study, and 70 comprised the full analysis set. The mean (SD) change from baseline in the sum score of the four 'affective dimension' items was -1.3 (2.8) indicating a numerical improvement (baseline: 3.9 [3.4]). In the 'sensory dimension', pain was mostly perceived as 'pulling' at baseline (49/70 [70%]); 'largely true'/'very true'). Numerical improvements were observed in all UPDRS scores (mean [SD] change in UPDRS II+III: -5.3 [10.5]; baseline: 36.0 [15.9]), and in PDQ-8 total score (-2.0 [4.8]; baseline: 10.7 [5.9]). Adverse drug reactions were consistent with dopaminergic stimulation and transdermal administration.
  
  
  CONCLUSIONS
  The perception of the 'affective dimension' of PD-associated pain numerically improved in patients treated with rotigotine. ClinicalTrials.gov identifier: NCT01606670; https://clinicaltrials.gov/ct2/show/NCT01606670?term=NCT01606670&rank=1.
authors.affiliation: a Department of Neurology , University Hospital Cologne , Cologne , Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Timmermann
authors.affiliation: b Neurological Outpatient Clinic for Parkinson Disease and Deep Brain Stimulation , Gera , Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Oehlwein
authors.affiliation: c Kepler University Hospital , Department of Neurology II, Med Campus III , Linz , Austria.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Ransmayr
authors.affiliation: d Department of Neurology , UCB Pharma , Monheim am Rhein , Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Fröhlich
authors.affiliation: d Department of Neurology , UCB Pharma , Monheim am Rhein , Germany.
authors.forename: Edgar
authors.initials: E
authors.lastname: Will
authors.affiliation: d Department of Neurology , UCB Pharma , Monheim am Rhein , Germany.
authors.forename: Hanna
authors.initials: H
authors.lastname: Schroeder
authors.affiliation: d Department of Neurology , UCB Pharma , Monheim am Rhein , Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lauterbach
authors.affiliation: d Department of Neurology , UCB Pharma , Monheim am Rhein , Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Bauer
authors.affiliation: e Department of Neurology , University of Ulm , Ulm , Germany.
authors.forename: Jan
authors.initials: J
authors.lastname: Kassubek
mesh_terms: D000203:Activities of Daily Living; D000279:Administration, Cutaneous; D000368:Aged; D000369:Aged, 80 and over; D001317:Austria; D018491:Dopamine Agonists / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000209:etiology*; D010300:Parkinson Disease / Q000150:complications*; D011795:Surveys and Questionnaires; D013764:Tetrahydronaphthalenes / Q000627:therapeutic use*; D013876:Thiophenes / Q000627:therapeutic use*
chemical_list: D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine
keywords: Observational study; Parkinson’s disease; dopamine receptor agonist; pain; rotigotine