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Clinical Trials/NCT01893073
NCT01893073
Completed
Not 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 enrollmentJune 2013
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ConditionsChronic Low Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Charite University, Berlin, Germany
Enrollment
48
Locations
1
Primary Endpoint
Pain intensity on visual analogue scale
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
March 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Benno Brinkhaus

Professor

Charite University, Berlin, Germany

Eligibility 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

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)

Study Sites (1)

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