title: Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms.
  
  
  METHODS
  A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique.
  
  
  CONCLUSIONS
  The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy of a specific technique or a pre-determined protocol.
  
  
  BACKGROUND
  The protocol has been registered on ClinicalTrials.gov ( NCT02146677 ) on 20 May 2014.
authors: Clinical-based Human Research Department, C.O.ME. Collaboration, Via Amerigo Vespucci 188, 65126, Pescara, Italy. francesco.cerritelli@gmail.com.|Accademia Italiana Osteopatia Tradizionale, Via Prati 29, 65124, Pescara, Italy. francesco.cerritelli@gmail.com.
authors: Francesco
authors: F
authors: Cerritelli
authors: Clinical-based Human Research Department, C.O.ME. Collaboration, Via Amerigo Vespucci 188, 65126, Pescara, Italy. cicchittiluca@gmail.com.|Accademia Italiana Osteopatia Tradizionale, Via Prati 29, 65124, Pescara, Italy. cicchittiluca@gmail.com.
authors: Luca
authors: L
authors: Cicchitti
authors: Clinical-based Human Research Department, C.O.ME. Collaboration, Via Amerigo Vespucci 188, 65126, Pescara, Italy. martamartelli@msn.com.|Accademia Italiana Osteopatia Tradizionale, Via Prati 29, 65124, Pescara, Italy. martamartelli@msn.com.
authors: Marta
authors: M
authors: Martelli
authors: Accademia Italiana Osteopatia Tradizionale, Via Prati 29, 65124, Pescara, Italy. gina.barlafante@aiot.edu.
authors: Gina
authors: G
authors: Barlafante
authors: Accademia Italiana Osteopatia Tradizionale, Via Prati 29, 65124, Pescara, Italy. cinzia.renzetti62@gmail.com.
authors: Cinzia
authors: C
authors: Renzetti
authors: Accademia Italiana Osteopatia Tradizionale, Via Prati 29, 65124, Pescara, Italy. gianfranco.pizzolorusso@gmail.com.
authors: Gianfranco
authors: G
authors: Pizzolorusso
authors: Accademia Italiana Osteopatia Tradizionale, Via Prati 29, 65124, Pescara, Italy. mariacristina.lupacchini.do@gmail.com.
authors: Mariacristina
authors: M
authors: Lupacchini
authors: Accademia Italiana Osteopatia Tradizionale, Via Prati 29, 65124, Pescara, Italy. marianna.dorazio@gmail.com.
authors: Marianna
authors: M
authors: D'Orazio
authors: Accademia Italiana Osteopatia Tradizionale, Via Prati 29, 65124, Pescara, Italy. benedettamarinelli.osteo@gmail.com.
authors: Benedetta
authors: B
authors: Marinelli
authors: Accademia Italiana Osteopatia Tradizionale, Via Prati 29, 65124, Pescara, Italy. vincenzo.cozzolino@aiot.edu.
authors: Vincenzo
authors: V
authors: Cozzolino
authors: Neonatal Intensive Care Unit, Pescara's public hospital, Via Fonte Romana 8, 65124, Pescara, Italy. ifusilli@alice.it.
authors: Paola
authors: P
authors: Fusilli
authors: Neonatal Intensive Care Unit, Pescara's public hospital, Via Fonte Romana 8, 65124, Pescara, Italy. neonatologia.pe@ausl.pe.it.
authors: Carmine
authors: C
authors: D'Incecco
mesh_terms: D002983:Clinical Competence; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005865:Gestational Age; D017721:Hospital Costs; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D007558:Italy; D007902:Length of Stay; D026301:Manipulation, Osteopathic / Q000191:economics; D010146:Pain / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000517:prevention & control*; D010147:Pain Measurement; D011446:Prospective Studies; D012107:Research Design; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D062606:Tertiary Care Centers; D013997:Time Factors; D016896:Treatment Outcome