Mindful Walking in Low Back Pain
MW-LBP
Effectiveness of a a Mindful Walking Program in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
1 other identifier
interventional
48
1 country
1
Brief Summary
The purpose of this study is to determine whether a mindful walking program is effective in the treatment of patients with chronic low back pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 2, 2013
CompletedFirst Posted
Study publicly available on registry
July 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedMarch 26, 2014
March 1, 2014
9 months
July 2, 2013
March 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity on visual analogue scale
8 weeks
Secondary Outcomes (6)
Back function - FFbH-R-Questionnaire
8 weeks, 12 weeks
Pain intensity on visual analogue scale
12 weeks
Cohens perceived stress scale
8 weeks, 12 weeks
Quality of Life - SF 36
8 weeks, 12 weeks
Intake of paracetamol
8 weeks
- +1 more secondary outcomes
Study Arms (2)
Mindful walking
ACTIVE COMPARATORA weekly 60 minutes walking group exercise program consisting of a combination of walking and mindfulness over 8 weeks.
Waiting group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- male and female, 18-65 years
- chronic low back pain (disease duration \> 3 months)
- only pharmacological treatment with NSAID or no treatment in the last 4 weeks
- undersigned informed consent form
You may not qualify if:
- active walking or jogging in the last 6 weeks (\< 60 minutes/week)
- regular meditation, relaxation exercise, mindfulness exercise in last 6 weeks (\> 30 minutes per week)
- use of complementary medicine therapies as acupuncture, homeopathy, herbal medicine in last 6 weeks or planned in the next 12 weeks
- use of other nonpharmacological therapies as physical therapy, manual therapy or osteopathy in the last 4 weeks
- participation in another trials within the last 3 months
- pathological neurological symptoms such as muscular paralysis or paraesthesia due to spinal disc herniation or other causes
- risk of falls and inability to walk
- angina pectoris in the last 3 months
- chronic respiratory disease with respiratory insufficiency
- intake of central nervous system-acting analgesics in the last 6 weeks
- Known renal and / or hepatic diseases
- Severe organic, psychological or psychiatric disorders that are not permitting a study participation
- applying for early retirement due to low back pain
- no undersigned informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Germany
Berlin, State of Berlin, 10117, Germany
Related Publications (1)
Rotter G, Ortiz M, Binting S, Tomzik J, Reese F, Roll S, Brinkhaus B, Teut M. Mindful Walking in Patients with Chronic Low Back Pain: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jun;28(6):474-483. doi: 10.1089/jicm.2021.0361. Epub 2022 Mar 30.
PMID: 35363058DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 2, 2013
First Posted
July 8, 2013
Study Start
June 1, 2013
Primary Completion
March 1, 2014
Last Updated
March 26, 2014
Record last verified: 2014-03