Mindfulness-Based Pain Management (MBPM) for Patients With Chronic Musculoskeletal Pain

NCT05199805 | Completed

• 1 other identifier: 21-10081-BO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Mindfulness-Based Pain Management (MBPM) is an eight-week behavioral medicine program. Based on the well-known Mindfulness-Based Stress Reduction (MBSR) program, it was specifically developed as an intervention for chronic pain. During the program, mindfulness exercises, gentle body exercises and body awareness and breathing exercises, as well as pain regulation methods are taught. Initial studies suggest efficacy of the program with regard to chronic pain, however, the effect of the standardized program in patients with chronic musculoskeletal pain has not yet been investigated in a clinical study. Therefore, the aim of this study is to investigate the MBPM program on pain acceptance in patients with chronic musculoskeletal pain. To this end, 40 patients with chronic (specific and non-specific) musculoskeletal pain will be randomly assigned to two study conditions. The intervention group will receive MBPM sessions of 150 minutes once a week over the course of 8 weeks, while the control group will receive standard therapy (waiting list). We hypothesize that patients will indicate a significantly higher pain acceptance after completing the program compared to patients not participating in the program.

Conditions

Chronic Pain

Keywords

mindfulness; self-compassion; radnomized controlled trial

Outcome Measures

Primary Outcomes (1)

• pain acceptance

  Chronic Pain Acceptance Questionnaire, 20 items, range 0-6 with higher scores indicating a better outcome

  week 8

Secondary Outcomes (6)

• pain acceptance

  week 26

• pain-associated self-efficacy

  week 8 and 26

• pain intensity

  week 8 and 26

• functional impairment

  week 8 and 26

• health-related quality of life

  week 8 and 26

Other Outcomes (5)

• mindfulness

  week 8 and 26

• self-compassion

  week 8 and 26

• adverse events

  week 8 and 26

Study Arms (2)

Mindfulness-based pain management

EXPERIMENTAL

The program consists of sessions of 150 minutes once a week over the course of 8 weeks. Treatment as usual is allowed.

Behavioral: Mindfulness-based pain management

Waiting-List

NO INTERVENTION

The control group will receive no active intervention in addition to treatment as usual during the study period.

Interventions

Mindfulness-based pain management BEHAVIORAL

The structured program will include mindfulness exercises, meditation, a gentle body exercise series, and body awareness exercises, as well as information about pain, mindfulness-based pain management, and pain regulation methods suitable for everyday life. During the 8 weeks, treatment as usual is allowed.

Also known as: Breathworks

Mindfulness-based pain management

Eligibility Criteria

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

You may qualify if:

• \- Chronic specific or nonspecific musculoskeletal pain for at least 3 months

You may not qualify if:

• New diagnosis within the last 3 months of:
• Degenerative diseases (e.g., herniated disc, spinal stenosis)
• Neurological diseases (e.g., neuropathies, multiple sclerosis)
• Injuries of the spinal column (e.g. due to whiplash, vertebral body fractures, operations)
• Or severe concurrent diagnosis of:
• Severe comorbid mental illness (e.g. addiction, severe depression)
• Severe comorbid physical illness (e.g. cancer diagnosis within the last 5 years, severe preexisting disease of the cardiovascular system, insufficiency of other organs (kidney, liver, etc.), acute febrile infection, other severe neurological diseases such as epilepsy)
• Pregnancy
• Current pension application (for work incapacity, occupational disability, reduction in earning capacity, severe disability)
• Simultaneous participation in other clinical trials

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Universität Duisburg-Essen

Essen, Nordrhein-Westphalia, 45276, Germany

Location

Related Publications (1)

• Cusens B, Duggan GB, Thorne K, Burch V. Evaluation of the breathworks mindfulness-based pain management programme: effects on well-being and multiple measures of mindfulness. Clin Psychol Psychother. 2010 Jan-Feb;17(1):63-78. doi: 10.1002/cpp.653.

  PMID: 19911432 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Holger Cramer, PhD

  Universität Duisburg-Essen

  PRINCIPAL INVESTIGATOR

• Heidemarie Haller, PhD

  Universität Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data collectors will be blinded. Blinding of study participants is not possible due to the study design.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. rer. medic. Holger Cramer

Model Details: 40 patients with chronic (specific and non-specific) musculoskeletal pain will be randomized into two study conditions. The intervention group will receive MBPM sessions of 150 minutes each once a week for 8 weeks, while the control group will receive standard therapy (waiting list). The control group does not receive any active intervention in addition to treatment as usual during the intervention period. After completion of data collection, the control group will be offered an identical program, 6 months after randomization.

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 20, 2022
• Study Start: January 21, 2022
• Primary Completion: July 31, 2022
• Study Completion: November 14, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)