title: Methodological quality of randomized controlled trials of spinal manipulation and mobilization in tension-type headache, migraine, and cervicogenic headache.
abstract: METHODS
  Literature review of quality of clinical trials.
  
  
  OBJECTIVE
  To determine the methodological quality of published randomized controlled trials that used spinal manipulation and/or mobilization to treat patients with tension-type headache (TTH), cervicogenic headache (CeH), and migraine (M) in the last decade.
  
  
  BACKGROUND
  TTH, CeH, and M are the most prevalent types of headaches seen in adults. Individuals who have headaches frequently use physical therapy, manual therapy, or chiropractic care. Randomized controlled trials are considered an optimal method with which to assess the efficacy of any intervention.
  
  
  METHODS
  Computerized literature searches were performed in MEDLINE, EMBASE, COCHRANE, AMED, MANTIS, CINHAL, and PEDro databases. Randomized controlled trials in which spinal manipulation and/or mobilization had been used for TTH, CeH, and M published in a peer-reviewed journal as full text, and with at least 1 clinically relevant outcome measure (ie, headache intensity, duration, or frequency) were reviewed. The methodological quality of the studies was assessed independently by 2 reviewers using a set of predefined criteria.
  
  
  RESULTS
  Only 8 studies met all the inclusion criteria. One clinical trial evaluated spinal manipulation and mobilization together, and the remaining 7 assessed spinal manipulative therapy. No controlled trials analyzing exclusively the effects of spinal mobilization were found. Methodological scores ranged from 35 to 56 points out of a theoretical maximum of 100 points, indicating an overall poor methodology of the studies. Only 2 studies obtained a high-quality score (greater than 50 points). No significant differences in quality scores were found based on the type of headache investigated. Methodological quality was not associated with the year of publication (before 2000, or later) nor with the results (positive, neutral, negative) reported in the studies. The most common flaws were a small sample size, the absence of a placebo control group, lack of blinded patients, and no description of the manipulative procedure.
  
  
  CONCLUSIONS
  There are few published randomized controlled trials analyzing the effectiveness of spinal manipulation and/or mobilization for TTH, CeH, and M in the last decade. In addition, the methodological quality of these papers is typically low. Clearly, there is a need for high-quality randomized controlled trials assessing the effectiveness of these interventions in these headache disorders.
authors.affiliation: Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain. cesar.fernandez@urjc.es
authors.forename: César
authors.initials: C
authors.lastname: Fernández-de-las-Peñas
authors.forename: Cristina
authors.initials: C
authors.lastname: Alonso-Blanco
authors.forename: Jesús
authors.initials: J
authors.lastname: San-Roman
authors.forename: Juan C
authors.initials: JC
authors.lastname: Miangolarra-Page
mesh_terms: D020773:Headache Disorders / Q000628:therapy*; D006801:Humans; D020393:Manipulation, Spinal; D008881:Migraine Disorders / Q000628:therapy; D051298:Post-Traumatic Headache / Q000628:therapy; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D012107:Research Design; D018781:Tension-Type Headache / Q000628:therapy; D016896:Treatment Outcome