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

IBS Granada

Status: Active, not recruiting

Conditions: Neurologic Manifestations; Back Pain; Pain, Chronic; Behavior, Health; Low Back Pain

Treatments: Behavioral: Multimodal + Resistance Programs; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06114264

iBSGranada

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Control Group

Sham Comparator group

Description:

This group will not receive any treatment during the intervention period.

Treatment:

Other: Control group

Multimodal + Resistance Program

Experimental group

Description:

Multimodal program including exercise program 2 days / week (45 minutes per session) during a period of 8 weeks + Behaviour change program daily /24 hours via a wrist-worn activity prompting device during a period of 8 weeks + Education program 2 days / week (1.5 hour per session, except the final session lasting 2 hours) during a period of 3 weeks + Mindfulness intervention 1 day / week (2.5 hour per session) during a period of 8 weeks, and will continue with an extended exercise program (functional resistance training) additionally 3 days / week (50 minutes per session) during 8 weeks.

Treatment:

Behavioral: Multimodal + Resistance Programs