NCT01893073

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

July 2, 2013

Last Update Submit

March 25, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain intensity on visual analogue scale

    8 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Mindful walking

ACTIVE COMPARATOR

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

Behavioral: Mindful walking program

Waiting group

NO INTERVENTION

Interventions

Mindful walking

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male and female, 18-65 years
  • chronic low back pain (disease duration \> 3 months)
  • only pharmacological treatment with NSAID or no treatment in the last 4 weeks
  • undersigned informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 8, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2014

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations