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Completed

NCT Number: NCT01893073

Mindful Walking in Low Back Pain

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful walking program

Behavioral

Primary outcomes

  1. Pain intensity on visual analogue scale

    Time frame: 8 weeks

Secondary outcomes

  1. Back function - FFbH-R-Questionnaire

    Time frame: 8 weeks, 12 weeks

  2. Pain intensity on visual analogue scale

    Time frame: 12 weeks

  3. Cohens perceived stress scale

    Time frame: 8 weeks, 12 weeks

  4. Quality of Life - SF 36

    Time frame: 8 weeks, 12 weeks

  5. Intake of paracetamol

    Time frame: 8 weeks

  6. Adverse events

    Time frame: 8 weeks, 12 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: MW-LBP

Important dates

Study start
2013
Primary completion
2014
First posted
Jul 8, 2013
Registry last updated
Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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