Meditation Based Lifestyle Modification in Chronic Pain

Pain, Chronic Clinical Trial

— MBLM-P  

Official title:

Meditation Based Lifestyle Modification in Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089618
• Other study ID #: MBLM-P
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: July 2020
• Source: Diakonie Kliniken Zschadraß
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

MBLM is a holistic therapy for people with mental disorders whose feasibility positive effects on patients with depression have already been demonstrated in clinical application and a piloted study. In the present trial, the feasibility and effect of MBLM on patients with chronic pain will be investigated.

Description:

MBLM expands existing concepts of mind-body medicine with ethical and spiritual concepts from the traditional Patanjali Yoga system, which can act as a coping factor on the one hand, and higher motivation and deepening of self-administered practice (mindfulness based exercises, body-oriented yoga exercises and mantra meditation). MBLM aims to establish an exercise routine in the daily lives of the participants, which leads to salutogenesis. The promotion of mental health through meditation and yoga has been well documented, also in clinical populations. The effects of meditation and yoga on addiction and pain are promising, but there is still a need for research. Furthermore, the preventive potential of the MBLM program will be examined for healthy volunteers, analogous to the already well-researched and widely used MBSR (Mindfulness Based Stress Reduction) program, which was originally also developed for patients with pain disorders.

The study will be conducted as an experimental single case analysis with multiple baseline design. Randomization takes place over time instead of control groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Outpatients

2. Current diagnosis of a chronic pain disorder.

3. Over 18 years old.

4. Physically able to perform simple yoga postures and sit for 20 minutes.

5. Have given your written consent to participate in the study.

Exclusion Criteria:

1. Psychotic symptoms

2. Acute suicidality

3. obsessive-compulsive disorder

4. Cerebro-organic diseases with clinically relevant symptoms

5. Severe multimorbidity

6. Current participation in another meditation or yoga study

7. Regular meditation or yoga practice (> once a week in the last 6 months)

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Behavioral:
• MBLM
Complex 8 week Mind-Body program.

Locations

Country	Name	City	State
Germany	Diakoniekliniken Zschadraß	Colditz	Sachsen

Sponsors (3)

Lead Sponsor	Collaborator
Diakonie Kliniken Zschadraß	Chemnitz University of Technology, Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life	WHOQol-BREF	at week 0 and week 11
Other	Chronic Pain Self-Efficacy	CPSS (Anderson et al, 1995)	at week 0 and week 11
Other	Distress Tolerance	Distress tolerance (Simons & Gaher, 2005)	at week 0 and week 11
Other	Spiritual and Religious Attitudes in Dealing with Illness	SpREUK (Büssing A., 2010)	at week 0 and week 11
Other	Trigunas - Emotion, Cognition and Health Behaviour	TGS Subscales (Puta & Sedlmeier, 2014)	at week 0 and week 11
Other	Illness Cognition	Illness Cognition Questionnaire for Chronic Diseases (Evers et al., 2001)	at week 0 and week 11
Primary	Pain VAS	Visual Analog Scale for Pain	through study completion, daily for around 3 months
Primary	Pain medication	Use of pain medication	through study completion, daily for around 3 months
Primary	Well-Being	The WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998)	through study completion, daily for around 3 months
Secondary	Emotion Regulation	Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2003)	through study completion, weekly for around 3 months
Secondary	Body awareness	adapted from Private-Body-Consciousness-Scale (PBCS; Miller, Murphy, & Buss, 1981), Body-Awareness-Questionnaire" (BAQ; Shields, Mallory & Simon, 1989) and Multidimensional Assessment of Interoceptive Awareness" (MAIA; Mehling et al., 2012)	through study completion, twice weekly for around 3 months
Secondary	Mind-Wandering	a) Mind-Wandering Questionnaire (MWQ; Mrazek, Phillips, Franklin, Broadway, & Schooler, 2013)	through study completion, weekly for around 3 months
Secondary	Depression, Anxiety & Stress	DASS (Nilges & Essau, 2015)	through study completion, weekly for around 3 months
Secondary	Pain Self Efficacy	PAIN SELF EFFICACY QUESTIONNAIRE (PSEQ) M.K.Nicholas (1989)	through study completion, weekly for around 3 months