Mindful Walking in Low Back Pain (MW-LBP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benno Brinkhaus, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01893073
First received: July 2, 2013
Last updated: March 25, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Pain intensity on visual analogue scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Back function - FFbH-R-Questionnaire [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Pain intensity on visual analogue scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Cohens perceived stress scale [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Life - SF 36 [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Intake of paracetamol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Benno Brinkhaus, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01893073     History of Changes
Other Study ID Numbers: MW-LBP
Study First Received: July 2, 2013
Last Updated: March 25, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 15, 2014