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 range

18 Years – 65 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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)

Trial details

NCT IDNCT06114264

SponsorIBS Granada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Pain, Chronic trials