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Pool J.1, Maissan F.1, de Waele N.2, Wittink H.1
1University of Applied Science Utrecht, Lifestyle and Health, Utrecht, Netherlands, 2Private Practice, Utrecht, Netherlands
Background: The Randomised Clinical Trial is considered as the golden standard regarding the effects of treatment. Still questions arise about the generalizability or the external validity of the outcomes. Especially the question arises can we use the outcome of an RCT in a clinical setting. The most used term is external validity, which is defined in different ways in literature. One definition is the extent of which the result of a trial is relevant to clinical practice, i.e. the intervention is reasonably likely to be replicated. Alongside an extended review on the clinical reasoning process in randomized clinical trials with patients with non-specific neck pain, articles were selected with the interventions mobilization and or manipulation.
Purpose: The research question was; What is the external validity of mobilization and or manipulation techniques on neck pain patients in randomized controlled trials as external validity is defined as the extend of which the intervention is reasonably likely to be replicated.
Methods: A comprehensive literature search was performed in MEDLINE, CINAHL and PEDro from inception to July 2016. A study was included if it met the following criteria: full-text original article, published in English, adult patients (>18 years) with non-specific neck pain as their main complaint, manual therapy intervention consisting of mobilisation or manipulation techniques and randomized controlled trial (RCT).
The TIDieR checklist, a 12 item checklist for describing interventions was used (Hoffman 2014). Two reviewers, experienced manual therapists, independently scored the clinical relevance of the included studies (FM and NdeW).
Results: 53 RCTs were selected in which mobilization and or manipulation techniques were a topic of the research. Results showed 52,8 % conformation on the question: Can the used intervention be replicated . Still information about the dose, frequency and intensity of the used interventions is inconsistent and not very clear in most of the trials.
Conclusion(s): Although in 47,2 % of the selected RCTs the intervention could not be replicated this result is encouraging. A reasonable difference compared with for example the results of Glasziou 2010 who assessed published trials in back pain patients. Only 13 % of the interventions were replicable due to insufficient information for consumers. The study of Yamato 2015 showed that in 23 % off all trials (n=200) at least half of the items of the tidier list was not described. If the current results are due to the kind of interventions is a possibility, mobilization and manipulation techniques, which can be described reasonable well. The challenge in the description of these interventions in clinical trials is the dose, frequency and intensity. Furthermore the level of intervention which is also a topic of debate.
Implications: Authors of research on intervention in manual therapy should give more emphasis on the correct description of the intervention in terms of technique, dose, frequency, intensity and location. The TiDieR checklist can be used as a format.
Funding acknowledgements: No funding
Topic: Research methodology & knowledge translation
Ethics approval: No ethical approval was neccessary
All authors, affiliations and abstracts have been published as submitted.