Mindful Walking in Low Back Pain

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Mindful walking program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindful walking<br>A weekly 60 minutes walking group exercise program consisting of a combination of walking and mindfulness over 8 weeks. | Behavioral: Mindful walking program<br> <br> |
| No Intervention: Waiting group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity on visual analogue scale |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Adverse events |  | 8 weeks, 12 weeks |