Clinical trial NCT01407549: The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients
Official title: The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients Evaluating Personal Characteristics and Possible Mechanism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Osteoarthritis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 67
Sex: ALL
Minimum age (years): 24
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients who suffer from recurrent chronic low back pain
2. Patients who suffer from osteoarthritis pains.
3. The pain has to be persistent for 3 months or longer and at least moderate in severity.

Exclusion Criteria:

1. mental illness with psychotic features
2. cognitive impairment
3. a history of an inpatient admission for psychiatric disorder within the past two years
4. diagnosis of a life threatening medical condition (e.g., cancer)
5. patients who are planning to start using other types of alternative interventions parallel to the Mindfulness Program.

Primary outcomes:
measure: change in Brief Pain Inventory Short Form questionnaire (BPI-sf)
timeFrame: Administration will take place upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
Secondary outcomes:
measure: Brief Symptom Inventory (BSI)
timeFrame: upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
measure: SF-12 Quality of life
timeFrame: upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
measure: Psychophysical measures
timeFrame: at the entry into the study, and after 6 weeks
measure: The Pain Catastrophizing Scale
timeFrame: upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
measure: The Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: upon entry into the study, after 4 weeks of participating in the program, and at the completion of the 6-weeks programs. Follow up of psychological measures will be held 3 months after completing the program by telephone.
measure: Anxiety Sensitivity Index (ASI)
timeFrame: at the entry into the study, and after 6 weeks
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: at the entry into the study, and after 6 weeks
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Clalit Health Service
Study officials:
affiliation: Clalit Health Service
name: Pesach Shvartzman, M.D
role: PRINCIPAL_INVESTIGATOR
References: