Exercise and Mindfulness in Patients With Non-specific Chronic Low Back Pain: The BACKFIT Project

Study Overview
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Brief Summary
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Chronic low back pain is among the most common health problems seen in primary care, and is responsible for disability and absenteeism in our country. In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP). Taking into consideration that multidimensional programs usually present more effectiveness reducing pain than unimodal programs, the current research investigates the role of unexplored multidimensional program (exercise and mindfulness) in NSCLBP. The primary aim of this project is to determine the effectiveness of a supervised exercise program (intervention 1) and a supervised exercise program + mindfulness (intervention 2) on pain, disability, trunk muscle endurance/strength, quality of life and gait parameters in patients with NSCLBP.

Official Title
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Multidimensional Approach (Exercise and Mindfulness) for Health Improvement in Patients With Non-specific Chronic Low Back Pain: The BackFit Project

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Exercise + mindfulness
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be previously diagnosed with NSCLBP pain by a healthcare professional according to the criteria established by O'Sullivan et al. Intend to participate in the intervention and perform all the tests included in the study. Able to read and understand informed consent, as well as the objective of the study. Able to walk and move without outside help. Able to communicate without problems Be between 18 and 65 years old. Exclusion Criteria: Having spondylolysis, spondylolisthesis, canal stenosis, degenerative disc disease, and/or disc herniation, tumor, trauma or fracture of the lumbar and lower limbs, Cauda equina syndrome, and radicular leg pain (given that spine degeneration issues are commonly present in asymptomatic individuals and increase with age, only serious lumbar structural disorders were considered). Having lumbar surgery as source of pain. Having acute or terminal illness. Having medical prescription that prevents the performance of the tests. Having injury or circumstance that makes it impossible to perform the tests correctly. Having other physical or mental illness that prevents participating in the intervention.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks. | Behavioral: Exercise<br>* The exercise intervention will focus on working the core muscles, starting with low-intensity isometric contraction of the core muscles that stabilize the trunk; increasing intensity by performing functional tasks (phase 1: independent isometric contraction of transversus-abdominis and multifidus, phase 2: co-contraction and functional tasks of the deep trunk muscles; phase 3: functional task with load; phase 4: functional task with unstable surface)<br>|
| Experimental: Exercise + mindfulness<br>The exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session). | Behavioral: Exercise + mindfulness<br>* The Mindfulness Based Stress Reduction (MBSR) program will strictly follow the protocol developed by Jon Kabat Zinn. Each session will include three activities: the presentation of a topic, moments of dialogue and exploration in group (using appreciative inquiry) and a Mindfulness practice. Participants will be provided with workbooks, audios with guided meditations, and instructions for practice at home. In addition, the Exercise + mindfulness intervention will include the exercise program described in the exercise intervention.<br>|
| Other: Control<br>The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks | Other: Control group<br>* The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Muscular fitness at 2 months: The trunk muscle strength/endurance | It will be measured with the Biering-Sørensen test and the plank test. | Change from baseline at 2 months (Postest minus Retest) | 
| Change from baseline Muscular fitness at 5 months: The trunk muscle strength/endurance | It will be measured with the Biering-Sørensen test and the plank test. | Change from baseline at 5 months (Retest minus Pretest) | 
| Change from baseline Muscular fitness at 2 months: lower body strength | It will be measured by the 30s chair stand test. Upper body strength (maximal isometric strength) will be measured with the handgrip strength test (TKK dynamometer). | Change from baseline at 2 months (Postest minus Retest) | 
| Change from baseline Muscular fitness at 5 months: lower body strength | It will be measured by the 30s chair stand test. Upper body strength (maximal isometric strength) will be measured with the handgrip strength test (TKK dynamometer). | Change from baseline at 5 months (Retest minus Pretest) | 
| Change from baseline Muscular fitness at 2 months: upper body strength | It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer). | Change from baseline at 2 months (Postest minus Retest) | 
| Change from baseline Muscular fitness at 5 months: upper body strength | It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer). | Change from baseline at 5 months (Retest minus Pretest) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, mindfulness, sedentary behaviour, strength, pain