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Mindful Walking in Low Back Pain (MW-LBP)

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mindful walking program
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Mindful walking

Waiting group

Arm Description

A weekly 60 minutes walking group exercise program consisting of a combination of walking and mindfulness over 8 weeks.

Outcomes

Primary Outcome Measures

Pain intensity on visual analogue scale

Secondary Outcome Measures

Back function - FFbH-R-Questionnaire
Pain intensity on visual analogue scale
Cohens perceived stress scale
Quality of Life - SF 36
Intake of paracetamol
Adverse events

Full Information

First Posted
July 2, 2013
Last Updated
March 25, 2014
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01893073
Brief Title
Mindful Walking in Low Back Pain
Acronym
MW-LBP
Official Title
Effectiveness of a a Mindful Walking Program in Patients With Chronic Low Back Pain - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindful walking
Arm Type
Active Comparator
Arm Description
A weekly 60 minutes walking group exercise program consisting of a combination of walking and mindfulness over 8 weeks.
Arm Title
Waiting group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindful walking program
Primary Outcome Measure Information:
Title
Pain intensity on visual analogue scale
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Back function - FFbH-R-Questionnaire
Time Frame
8 weeks, 12 weeks
Title
Pain intensity on visual analogue scale
Time Frame
12 weeks
Title
Cohens perceived stress scale
Time Frame
8 weeks, 12 weeks
Title
Quality of Life - SF 36
Time Frame
8 weeks, 12 weeks
Title
Intake of paracetamol
Time Frame
8 weeks
Title
Adverse events
Time Frame
8 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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
Facility Information:
Facility Name
Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Germany
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
35363058
Citation
Rotter G, Ortiz M, Binting S, Tomzik J, Reese F, Roll S, Brinkhaus B, Teut M. Mindful Walking in Patients with Chronic Low Back Pain: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jun;28(6):474-483. doi: 10.1089/jicm.2021.0361. Epub 2022 Mar 30.
Results Reference
derived

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Mindful Walking in Low Back Pain

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