Osteoarthritis Clinical Trial
Official title:
The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients Evaluating Personal Characteristics and Possible Mechanism
Background: Chronic pain is a common condition in the general population, causing great
suffering in both physical and mental aspects. Previous research shows that mindfulness
based interventions help chronic pain patients to cope better with their pain, and improve
their quality of life. Although evidence support the efficacy of mindfulness based
interventions for chronic pain, it is still unclear whether this efficacy involves a direct
influence on sensory aspects of pain perception. Further more, the mechanisms of change
responsible for the improved life quality and the possible moderating factors that may
influence treatment efficacy, are still unknown.
Aim: The purpose of this study is to evaluate the efficacy of mindfulness based intervention
on pain perception and quality of life in individuals suffering from chronic pain. The
investigators will also evaluate potential mechanisms responsible for the change following
mindfulness practice. Finally the investigators will examine the role of personal
characteristics as potential moderating factors of mindfulness effect.
Hypothesis: The investigators hypothesize that 1) compared to a waitlist control group,
chronic pain patients participating in a full mindfulness based program will report greater
improvements in a) pain severity, b) quality of life and psychological symptoms, and c) will
demonstrate changes in physiological characteristics of pain. 2) Changes following the
mindfulness based program will be mediated by change in pain catastrophizing, self
regulation capacity and pain acceptance. 3) The investigators hypothesize that gender,
baseline mindfulness, and anxiety sensitivity will moderate the efficacy of the mindfulness
based program.
Method: A randomized controlled design will be used to evaluate the efficacy of mindfulness
based intervention on pain perception and quality of life in individuals suffering from
chronic recurrent low back pain and osteoarthritis. Participants will be randomized to a
mindfulness based treatment group, or to a waitlist control group, and will be assessed for
psychological variables and psychophysical pain assessment before treatment. Participants
allocated to treatment group will then attend six group meetings in which they will learn
and practice different mindfulness meditation techniques, and will be asked to practice
these techniques on a daily basis. Post treatment assessments will take place at the end of
the intervention for both treatment and control groups.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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