NCT06114264

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: IBS Granada · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Chronic
• Neurologic Manifestations
• Back Pain
• Low Back Pain
• Behavior, Health

Interventions

Type	Name	Description
BEHAVIORAL	Multimodal + Resistance Programs	Exercise: will focus on working the all body by performing functional tasks. Behaviour change: An 'idle alert' of the wrist-worn activity prompter will be set to vibrate after 45 min without movement. Participants will be encouraged to take a 1-2 min activity break. Education: The basic contents will explain to the patient the main mechanism of chronic pain (pain as a protective system, consequences, etc). 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 and a Mindfulness practice. Resistance functional exercises will replicate functional movements, such as standing from a bed, carrying bags, picking up groceries from the ground, etc.
OTHER	Control group	No experimental intervention. The group will receive the same multimodal intervention as the experimental group when the experimental period is over.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2023-11-02
• Last updated: 2026-03-27

Locations

1 site across 1 country: Spain