Mindfulness Based Chronic Pain Management: A Pilot Study

Chronic Pain Clinical Trial

— MBCPM  

Official title:

The Efficacy of Mindfulness-Based Chronic Pain Management: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886885
• Other study ID #: IRB_00061111
• Status: Completed
• Start date: January 2013
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and increase pain acceptance in participants with chronic pain. The secondary objective is to explore if MBCPM will reduce depression and increase quality of life and mindfulness in the same group of participants. The additional aim of the pilot study is to evaluate the feasibility of conducting the MBCPM intervention in participants with chronic pain. We hypothesize that participants with chronic pain will show relatively good compliance with completing the MBCPM protocol and will show increased satisfaction associated with improvement in pain-related and other psychosocial indicators of functioning.

Description:

The Institute of Medicine in their recent report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research states that: "Common chronic pain conditions affect at least 116 million U.S. adults at a cost of $560-635 billion annually in direct medical treatment costs and lost productivity." (IOM, 2011, p. 1) Pain is defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage." (IASP, 2011). This widely accepted definition suggests that there are multiple components in the experience of pain, namely physiological and psychological. Pain has been reported as the most frequently reported symptom in primary care, while chronic pain is reported to affect 20-30% of the population in Western Countries. (Verhaak et al, 1998). Individuals with chronic pain often report co-morbid depression, anxiety, decreased quality of life, activity restriction, and inability to work or engage in productive activities. The most frequently used therapies are pharmacotherapy and surgical interventions, both of which have limitations in their effectiveness and tolerability.

A pressing need exists to develop alternative therapeutic modalities for caring for people with chronic pain. Mindfulness-based programs have emerged as effective interventions for different types of health conditions. Mindfulness is defined as "paying attention ina particular way, on purpose, in the present moment, and, non-judgmentally." (Kabat-Zinn, 1990) Research studies into mindfulness-based interventions have increased exponentially in the last three decades, based on the pioneering work of Jon Kabat-Zinn who developed Mindfulness-Based Stress Reduction (MBSR) in 1979. MBSR is a structured group based psycho-educational intervention that is conducted over a period of 8 weeks, with two hour classes occurring weekly. Each class teaches several mindfulness meditation practices such as sitting meditation, walking meditation, mindful yoga, and body scan. Participants are asked to complete homework assignments 6 out of 7 days following each session; these homework assignments provide opportunities to further engage in these practices so that they become more habitual. An all-day retreat occurs between weeks 6 and 7, providing further opportunities to engage in mindfulness practices.

Mindfulness-Based Chronic Pain Management (MBCPM) is an intervention developed by Jackie Gardner-Nix, MD, adapted from the standard MBSR curriculum for individuals suffering from chronic pain. The focus of this intervention is to teach clients skills that will facilitate the development of detached observation and reduce the experience of suffering through cognitive re-appraisal (Garder-Nix, 2008). The adaptations made in the MBCPM curriculum were based on the needs of individuals suffering from chronic pain; they include: increasing sessions to a 13 week long curriculum, replacing the mindful yoga with more gentle stretches, allowing participants to sit, stand, lie down, or move during sessions, and shortened mindfulness meditation practices. Additional therapeutic activities are also introduced throughout the program such as guided imagery and visualization, art techniques, and information about food and sleep. The length of homework assignments is also shortened from the original one hour length in MBSR to just 5-30 minutes a day in MBCPM, and there is no all-day Saturday retreat. These adaptations were made based on observations of difficulty that participants had with the original MBSR curriculum (Gardner-Nix, 2009b). Each class is two hours long with a break in the middle.

The current literature on chronic pain suggests that existing treatments have limited utility for chronic pain sufferers. "Currently available treatments have limited effectiveness for most people with severe chronic pain. For many such individuals, pain management on a daily basis takes place outside any health care setting." (IOM, 2011, p. 13) This statement from the Institute of Medicine report underscores the reasons why people turn to complementary and alternative medicine therapies - because they are not getting adequate relief from existing more conventional treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age

• English speaking

• Agree to participate

• Chronic pain for 3 months or more

Exclusion Criteria:

• Not speaking English

• Cognitive impairment

• Not able to commit to 13 week intervention

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Mindfulness Based Chronic Pain Management Intervention
Mindfulness-Based Chronic Pain Management (MBCPM) is an intervention developed by Jackie Gardner-Nix, MD for individuals suffering from chronic pain. The focus of MBCPM is to teach clients skills that will facilitate the development of detached observation and reduce the experience of suffering through cognitive re-appraisal. The activities used within MBCPM include mindfulness meditation, gentle stretching/mindful movement, guided imagery, art techniques, psychoeducation, and discussion. There are daily homework assignments of just 5-30 minutes a day in MBCPM. Each class is two hours long with a break in the middle.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The additional aim of the pilot study is to evaluate the feasibility of conducting the MBCPM intervention in participants with chronic pain.		6 months
Primary	The primary objective for this pilot study is to determine if the Mindfulness-Based Chronic Pain Management (MBCPM) intervention would decrease pain and pain catastrophizing and increase pain acceptance in participants with chronic pain.	The following assessments will be administered at the start of the intervention, at the end of the 13 week intervention, and at three month follow-up: Numerical Pain Rating Scale, Chronic Pain Acceptance Questionnaire, and the Pain Catastrophizing Scale	6 months
Secondary	The secondary objective is to explore if MBCPM will reduce depression and increase quality of life and mindfulness in the same group of participants.	The following assessments will be administered at the start of the intervention, at the end of the 13 week intervention, and at three month follow-up: Center for Epidemiologic Studies Depression Scale, the Five Factor Mindfulness Scale - Short Form, and the Quality of Life Scale.	6 months