CompletedNot Applicable

Multimodal Intervention in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project

Spain70 participantsStarted 2023-01-01

Plain-language summary

Low back pain is one of the most common health problems seen in the primary care. Chronic low back pain is localized between the inferior limit of the ribs and the sacral region, and persist more than 12 weeks. In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP). No previous study has included a multimodal supervised program in patients with NSCLBP. The primary aim of this study is to determine the effectiveness of exercise + behaviour change + education + mindfulness programs (intervention 1) and an intervention including intervention 1 following functional resistance training (Intervention 2) on endogenous pain modulation, disability, muscle strength/endurance, quality of life, gait parameters, levels of physical activity, sedentary behaviour and psychological health in patients with NSCLBP.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

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 al1. * 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. Exclusion Criteria: * Be under 20 years or over 65 years old. * 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 Conditioned Pain Modulation (CPM) in the lower back at 2 months

Timeframe: Change from baseline at 2 months (Posttest minus Pretest)

Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 3.5 months

Timeframe: Change from baseline at 3.5 months (Posttest minus Pretest)

Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 5 months

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

Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 2 months

Timeframe: Change from baseline at 2 months (Posttest minus Pretest)

Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 3.5 months

Timeframe: Change from baseline at 3.5 months (Posttest minus Pretest)

Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 5 months

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

Change from baseline Pressure pain threshold (PPT) in the lower back at 2 months

Timeframe: Change from baseline at 2 months (Posttest minus Pretest)

Trial details

NCT IDNCT06114264

SponsorIBS Granada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Pain, Chronic trials