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NCT Number: NCT01407549

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

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.

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Key information

Conditions

Low Back Pain Arthritis Back Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

24 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clalit Health Service

Beersheba, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

mindfulness group meetings with psychologist

Behavioral

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. Participants will attend weekly group meetings (15-20 individuals per group) in which they will be guided through a progressive experiential exploration of mindfulness. Participants will be asked to develop a daily meditation practice of 30-45 minutes with audio-recordings for guidance, and will report the amount and type of practice in a daily dairy. . A psychologist with rich personal experience in mindfulness who is trained in mindfulness based therapy will be responsible for administering the program.

Primary outcomes

  1. change in Brief Pain Inventory Short Form questionnaire (BPI-sf)

    Time frame: 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.

    measures and characterize pain and the interference of pain with the patient's life (reactive dimension). The BPI questionnaire includes a 0-10 rating scale to measure the pain and the influence of pain on different aspects of daily life (general activity, mood, sleep, relationship with other people, work) that constitute the life impact index

Secondary outcomes

  1. Brief Symptom Inventory (BSI)

    Time frame: 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.

    53 items and provides nine sub-scale scores measuring a range of psychological symptoms and somatic complaints. Participants rate on a scale of 0 ('not at all') to 4 ('extremely') how much they were bothered in the last 7 days by each of 18 symptoms, including separate scores for anxiety, depression, somatization, and a global symptom severity index

  2. SF-12 Quality of life

    Time frame: 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.

    The Short-Form General Health Survey is a shorter form of the widely used SF-36 and assesses health-related quality of life. It consists of 12 items that allow the calculation of 'physical health' (PCS-12) and 'mental health' (MCS-12) summary scales.

  3. Psychophysical measures

    Time frame: at the entry into the study, and after 6 weeks

    Using the The Thermal Sensory Analyzer we will measure Heat/ Cold pain threshold (HPT/CPT)and Supra threshold pain.

  4. The Pain Catastrophizing Scale

    Time frame: 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.

    Sullivan, Bishop, & Pivik, 1995) This questionnaire includes 13 items representing the three components of pain catastrophizing: rumination (e.g., "I can't seem to keep it out of my mind"); magnification (e.g., "I wonder whether something serious may happen"); and helplessness (e.g., "There is nothing I can do to reduce the intensity of pain").

  5. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: 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.

    consists of 36 self-report items which comprise six subscales that investigate individuals' complaints about emotional regulation problems. The scales are: Non-acceptance of Emotional Response, Difficulties engaging in Goal-Directed Behavior, Impulse Control Difficulties, Lack of Emotional Awareness, limited access to Emotion Regulation Strategies and Lack of Emotional Clarity. Respondents are asked to rate their self-perceptions regarding each item on a 5-point Likert scale, which ranges from "almost never" to "almost always."

  6. The Chronic Pain Acceptance Questionnaire (CPAQ)

    Time frame: 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.

    a 20-item, two factor (Activity Engagement and Pain Willingness) questionnaire, adapted through the process of factor analysis from the original, longer version (Geiser, 1992).

  7. Anxiety Sensitivity Index (ASI)

    Time frame: at the entry into the study, and after 6 weeks

    a 16-item measure on which respondents indicate, on a 5-point Likert-type scale (0=very little to 4=very much), the degree to which they fear the potential negative consequences of anxiety-related symptoms and sensations. The ASI is made up of one higher-order factor (ASI total score) and three lower-order factors: Physical, Psychological, and Social Concerns

  8. Mindful Attention Awareness Scale (MAAS)

    Time frame: at the entry into the study, and after 6 weeks

    a 15 item measure of mindfulness. The item content was design to reflect the opposite of the construct of mindfulness, or: "mindlessness" and thus endorsing the item content at a lower frequency is taken to represent a higher level of mindfulness.

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients Evaluating Personal Characteristics and Possible Mechanism

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2011
Registry last updated
Jun 30, 2015

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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