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Mindful Walking in Low Back Pain (MW-LBP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01893073
First Posted: July 8, 2013
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Benno Brinkhaus, Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention
Chronic Low Back Pain Behavioral: Mindful walking program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a a Mindful Walking Program in Patients With Chronic Low Back Pain - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Benno Brinkhaus, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Pain intensity on visual analogue scale [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Back function - FFbH-R-Questionnaire [ Time Frame: 8 weeks, 12 weeks ]
  • Pain intensity on visual analogue scale [ Time Frame: 12 weeks ]
  • Cohens perceived stress scale [ Time Frame: 8 weeks, 12 weeks ]
  • Quality of Life - SF 36 [ Time Frame: 8 weeks, 12 weeks ]
  • Intake of paracetamol [ Time Frame: 8 weeks ]
  • Adverse events [ Time Frame: 8 weeks, 12 weeks ]

Enrollment: 48
Study Start Date: June 2013
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mindful walking
A weekly 60 minutes walking group exercise program consisting of a combination of walking and mindfulness over 8 weeks.
Behavioral: Mindful walking program
No Intervention: Waiting group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893073


Locations
Germany
Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Germany
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

Responsible Party: Benno Brinkhaus, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01893073     History of Changes
Other Study ID Numbers: MW-LBP
First Submitted: July 2, 2013
First Posted: July 8, 2013
Last Update Posted: March 26, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms