The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients

Clalit Health Services

Status: Completed

Conditions: Osteoarthritis; Low Back Pain

Treatments: Behavioral: mindfulness group meetings with psychologist

Study type: Interventional

Funder types: Other

Identifiers

NCT01407549

MMC11114119KCTIL

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 24 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group will participate in the Mindfulness Program consists of one 2-hour session each week for 6 consecutive weeks plus a half day retreat near the end of the intervention.

Treatment:

Behavioral: mindfulness group meetings with psychologist

Control group

No Intervention group

Description:

Participants in the control group will be assigned to a waiting list group. Participants will be told that they will be eligible for the intervention three months after the completion of a preliminary documentation of their symptoms and additional measures. Participants will complete the same battery of measures according to the same time table as participants in the intervention group.