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

NCT01407549 | Completed

• 1 other identifier: MMC11114119KCTIL
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

  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

  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 (8)

• Brief Symptom Inventory (BSI)

  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.

• SF-12 Quality of life

  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.

• Psychophysical measures

  at the entry into the study, and after 6 weeks

• The Pain Catastrophizing Scale

  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.

• Difficulties in Emotion Regulation Scale (DERS)

  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.

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: mindfulness group meetings with psychologist

Control group

NO INTERVENTION

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.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 24 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Clalit Health Service

Beersheba, Israel

Location

MeSH Terms

Conditions

Low Back Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

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

Study Officials

• Pesach Shvartzman, M.D

  Clalit Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: August 2, 2011
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 30, 2015

Record last verified: 2012-06

Locations

IL (1)