Clinical trial NCT05443880: Exercise and Mindfulness in Patients With Non-specific Chronic Low Back Pain: The BACKFIT Project
Official title: Multidimensional Approach (Exercise and Mindfulness) for Health Improvement in Patients With Non-specific Chronic Low Back Pain: The BackFit Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Exercise, mindfulness, sedentary behaviour, strength, pain
Lead sponsor: IBS Granada
Sponsor class: OTHER
Collaborators: name: University Hospital Virgen de las Nieves
name: ISCIII
name: European Social Fund
First posted: 2022-07-05
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Muscular fitness at 2 months: The trunk muscle strength/endurance
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Muscular fitness at 5 months: The trunk muscle strength/endurance
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Muscular fitness at 2 months: lower body strength
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Muscular fitness at 5 months: lower body strength
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Muscular fitness at 2 months: upper body strength
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Muscular fitness at 5 months: upper body strength
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
Secondary outcomes:
Other outcomes:
measure: Change from baseline Pressure pain threshold (PPT) in the lower back at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Disability due to pain at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Disability due to pain at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Pain intensity at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Pain intensity at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Sedentary time and physical activity at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Sedentary time and physical activity at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Gait parameters at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Gait parameters at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Fat percentage at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Fat percentage at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Health-related quality of life at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Health-related quality of life at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Central sensitization at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Central sensitization at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Pain Catastrophyzing at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Pain Catastrophyzing at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Depression severity at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Depression severity at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Anxiety state at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Anxiety state at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: Change from baseline Sleep duration and quality at 2 months
timeFrame: Change from baseline at 2 months (Postest minus Retest)
measure: Change from baseline Sleep duration and quality at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
Locations:
city: Granada
country: Spain
facility: IBS.Granada
Study officials:
References: