CompletedNot Applicable

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

Spain105 participantsStarted 2022-01-01

Plain-language 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.

Who can participate

Age range20 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change from baseline Muscular fitness at 2 months: The trunk muscle strength/endurance

Timeframe: Change from baseline at 2 months (Postest minus Retest)

Change from baseline Muscular fitness at 5 months: The trunk muscle strength/endurance

Timeframe: Change from baseline at 5 months (Retest minus Pretest)

Change from baseline Muscular fitness at 2 months: lower body strength

Timeframe: Change from baseline at 2 months (Postest minus Retest)

Change from baseline Muscular fitness at 5 months: lower body strength

Timeframe: Change from baseline at 5 months (Retest minus Pretest)

Change from baseline Muscular fitness at 2 months: upper body strength

Timeframe: Change from baseline at 2 months (Postest minus Retest)

Change from baseline Muscular fitness at 5 months: upper body strength

Timeframe: Change from baseline at 5 months (Retest minus Pretest)

Trial details

NCT IDNCT05443880

SponsorIBS Granada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Low Back Pain trials