Methodological Quality of Randomized Controlled Trials of Spinal Manipulation and Mobilization in Tension-Type Headache, Migraine, and Cervicogenic Headache

Методологическое качество рандомизированных контролируемых исследований спинальных манипуляций и мобилизации при головной боли напряжения, мигрени и цервикогенной головной боли
César Fernández‐de‐las‐Peñas, Cristina Alonso‐Blanco, J. Fernández Sanromán, Juan Carlos Miangolarra‐Page
2006-03-01

headache disordersmethodological qualityrandomized controlled trialsspinal manipulationspinal mobilization
STUDY DESIGN: 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.
1
Frequent methodological limitations included small samples, absent placebo controls, nonblinded patients, and inadequate descriptions of manipulative procedures.
2
Methodological quality was generally poor, with scores ranging from 35 to 56 out of 100; only two studies exceeded 50 points.
3
Only 8 randomized controlled trials met inclusion criteria for spinal manipulation and/or mobilization in tension-type, cervicogenic, or migraine headache.
4
Quality scores did not differ significantly by headache type and were unrelated to publication year or reported treatment outcomes.
5
Seven trials evaluated spinal manipulative therapy, one combined manipulation and mobilization, and none examined spinal mobilization exclusively.

Published randomized controlled trials of spinal manipulation and/or mobilization for tension-type headache, cervicogenic headache, and migraine

Methodological quality and reported effectiveness of these trials, including study-design limitations and clinically relevant headache outcomes

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2006-03-01
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César Fernández‐de‐las‐Peñas
Cristina Alonso‐Blanco
J. Fernández Sanromán
Juan Carlos Miangolarra‐Page
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