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Filter by:There is marked uncertainty regarding the feasibility of achieving adequate blinding in randomized controlled trials of manual therapy. In other words, whether participants and outcome assessors can accurately perceive randomly assigned interventions is unclear. This feasibility trial was conducted as part of a doctoral epidemiology course at the University of Zurich, Switzerland. Within the practice-based context of the class and using a study population of healthy graduate students enrolled in the course, the investigators aimed to evaluate blinding of participants randomly assigned (similar to tossing a coin) to one of two manual therapy interventions (active versus control). The investigators also aimed to assess blinding among outcome assessors.
It was a randomized clinical trial conducted to determine the effects of patient education manual on pain, range of motion and function in patient with chronic low back pain at Salamat hospital Satellite Town Gujranwala in patients with 6-month chronic low back pain who were willing to follow patient education manual. Patients were assessed for pain, disability due to backpain and lumbar ranges, at baseline, 2nd, 4th and 6th week of intervention. The SPSS 20.0 version was used to analyse data. Tests of normality were executed that whether data was normative or non-parametric, based on which outcomes were compared either using independent samples t test or Mann-Whitney test.
1. Introduction 1.1 Description of the Trial The trial was a monocentric, open, randomized, 3-arm clinical trial that took place at the Department of Orthopaedics of the Karviná Miners' Hospital (Karvinská hornická nemocnice a.s.). The involvement of a maximum total number of 198 patients with chronic lumbar spine pain was planned; the patients were randomly and evenly assigned to one of the 3 treatment groups: 1. Use of the Dvectis Single pad; 2. Use of the Dvectis Double pad; 3. Use of no pad. One sequential interim analysis was planned in the middle of the clinical trial and after this interim analysis, the trial was stopped early due to proven efficacy. The expected period of participation of each patient in the clinical trial was 6 weeks (± 5 days). For an overview of the individual study visits and procedures, study population and other detailed information, see the study protocol. According to the plan, the assessment subject was asked during Visit 1 and Visit 2 about the most intensive pain felt in the last 48 hours (PI). The pain was recorded by the subject in the visual analogue scale (VAS) in CRF under supervision of the investigator. Then the assessment subject recorded the intensity of their pain independently in the Patient Journal daily. 1.2 Primary Objective, Quantity and Hypothesis The primary objective of the clinical trial was to assess the efficacy of using the Dvectis Single pad in comparison to "use of no pad" in patients suffering from chronic lumbar spine pain. PI was the primary quantity. The primary hypothesis was the superiority of Dvectis Single based on a check, assessed based on the difference in PI (PID) between week 2 and week 6 (PID6).