Mindful Walking in Low Back Pain (MW-LBP)

March 25, 2014 updated by: Benno Brinkhaus, Charite University, Berlin, Germany

Effectiveness of a a Mindful Walking Program in Patients With Chronic Low Back Pain - a Randomized Controlled Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity on visual analogue scale
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

July 5, 2013

First Posted (Estimate)

July 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MW-LBP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Low Back Pain

Clinical Trials on Mindful walking program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe