NCT01893073CompletedNot Applicable
Effectiveness of a a Mindful Walking Program in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
Charite University, Berlin, Germany1 site in 1 country48 target enrollmentStarted: June 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Pain intensity on visual analogue scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •male and female, 18-65 years
- •chronic low back pain (disease duration > 3 months)
- •pain intensity on visual analogue scale at inclusion > 40 mm (0-100 mm scale)
- •only pharmacological treatment with NSAID or no treatment in the last 4 weeks
- •undersigned informed consent form
Exclusion Criteria
- •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
Arms & Interventions
Mindful walking
Active Comparator
A weekly 60 minutes walking group exercise program consisting of a combination of walking and mindfulness over 8 weeks.
Intervention: Mindful walking program (Behavioral)
Waiting group
No Intervention
Outcomes
Primary Outcomes
Pain intensity on visual analogue scale
Time Frame: 8 weeks
Secondary Outcomes
- 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)
- Adverse events(8 weeks, 12 weeks)
Investigators
Benno Brinkhaus
Professor
Charite University, Berlin, Germany
Study Sites (1)
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