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Osteopathic Treatment of Patients with Chronic Non-Specific Neck Pain: Development of a Study Protocol

Journal: Unpublished MSc thesis A.T. Still University, Date: 2010, Pages: 179, type of study: randomized controlled trial

Free full text   (https://www.ostlib.de/up/datei/schwerla_these_us_final.pdf)

Keywords:

chronic pain [204]
non-specific neck pain [4]
cervical spine [210]
osteopathic manipulative treatment [2973]
OMT [2951]
protocol [35]
randomized controlled trial [710]

Abstract:

Background: Chronic non-specific neck pain (CNP) is a syndrome commonly encountered in the western world and is characterized with inconsistent etiology, pathology and symptoms. Among the many different contemporary therapeutic approaches available none seems compellingly superior to any other. As osteopaths, we see and treat many patients with CNP in our daily practice with encouraging perceived outcomes. Empiric evidence suggests that osteopathic interventions might be effective in alleviating CNP symptoms. However, the effectiveness of an osteopathic treatment approach to neck pain has so far been addressed in only a few small pilot trials. There have been no large clinical trials specifically assessing the effectiveness/efficacy of osteopathic treatment on patients with chronic non-specific neck pain. Objective: The aim of this master thesis was to develop a study design and protocol of a randomized controlled multi-center trial on the osteopathic treatment of patients with CNP. Available information will be analyzed and further strategies will be developed to scrutinize the role of an osteopathic approach. Methods: A comprehensive literature search of clinical trials, systematic reviews, meta-analyses, and guidelines in MEDLINE, EMBASE, the Cochrane Library, and other important databases published from 2000 through 2009 were screened for the latest relevant literature on CNP. In addition, trials were analyzed concerning methodological implications. A systematic review was conducted for trials on the osteopathic treatment of patients with CNP, and two small recently finished German pilot trials of a series of osteopathic treatments of CNP were analyzed. Results: Based on the findings of the literature review and other sources the following study protocol has been developed. In a randomized controlled multi-center trial with two groups a total of 150 subjects, 75 in each group with chronic non-specific neck pain will be included. The subjects allocated to the intervention group will receive five custom-tailored osteopathic treatments over 8 weeks. Two follow-ups, 3 and 6 months after the end of the treatments will be carried out. Subjects in the control group will remain untreated („waiting list“). Main outcome measure: neck related disability (Neck Disability Index, NDI); secondary parameters are pain intensity over the past 14 days measured by a visual analogue scale (VAS), health-related quality of life (SF-36), work disability, and psychosocial factors (DAPOS). Conclusion: This master thesis presents the rationale and design of a randomized controlled trial to determine the effectiveness of osteopathic treatment for patients with CPN.


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