Mindful Walking in Low Back Pain

Chronic Low Back Pain Clinical Trial

— MW-LBP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893073
• Other study ID #: MW-LBP
• Status: Completed
• Phase: N/A
• First received: July 2, 2013
• Last updated: March 25, 2014
• Start date: June 2013

Study information

• Verified date: March 2014
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• Mindful walking program

Locations

Country	Name	City	State
Germany	Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Germany	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity on visual analogue scale		8 weeks	No
Secondary	Back function - FFbH-R-Questionnaire		8 weeks, 12 weeks	No
Secondary	Pain intensity on visual analogue scale		12 weeks	No
Secondary	Cohens perceived stress scale		8 weeks, 12 weeks	No
Secondary	Quality of Life - SF 36		8 weeks, 12 weeks	No
Secondary	Intake of paracetamol		8 weeks	No
Secondary	Adverse events		8 weeks, 12 weeks	Yes