Clinical trial NCT06114264: Multimodal Intervention in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project
Official title: Multimodal Intervention to Improve Pain and Health in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain, Chronic
Neurologic Manifestations
Back Pain
Low Back Pain
Behavior, Health
Keywords: exercise
behaviour change
education
mindfulness
pain
strength
Lead sponsor: IBS Granada
Sponsor class: OTHER
Collaborators: name: University Hospital Virgen de las Nieves
name: Instituto de Salud Carlos III
First posted: 2023-11-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: 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)
measure: Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 5 months
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
measure: 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)
measure: 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)
measure: 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)
measure: Change from baseline Pressure pain threshold (PPT) in the lower back at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Pressure pain threshold (PPT) in the lower back at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Secondary outcomes:
measure: Change from baseline Disability due to pain at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Disability due to pain at 3.5 months
timeFrame: Change from baseline at 3.5 months (Posttest minus Pretest)
measure: Change from baseline Disability due to pain at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Pain intensity at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Pain intensity at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Pain intensity at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline physical activity and sedentary time at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline physical activity and sedentary time at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline physical activity and sedentary time at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Gait parameters at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Gait parameters at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Gait parameters at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Gait parameters at 2 months control and intervention group 1
timeFrame: Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Gait parameters at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Gait parameters at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Gait parameters at 2 months control and intervention group 1
timeFrame: Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Gait parameters at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Gait parameters at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Gait parameters at 2 months control and intervention group 1
timeFrame: Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Gait parameters at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Gait parameters at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Fat percentage at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Fat percentage at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Fat percentage at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Health-related quality of life at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Health-related quality of life at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Health-related quality of life at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Central sensitization at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Central sensitization at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Central sensitization at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Pain Catastrophyzing at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Pain Catastrophyzing at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Pain Catastrophyzing at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Depression severity at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Depression severity at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Depression severity at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Anxiety state at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Anxiety state at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Anxiety state at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Sleep duration and quality at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Sleep duration and quality at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Sleep duration and quality at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Haemostasis at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Haemostasis at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Haemostasis at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Specific Proteins at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Specific Proteins at 3.5 months
timeFrame: Change from baseline at 3.5 months (Posttest minus Pretest)
measure: Change from baseline Specific Proteins at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Specific Proteins at 2 months control and intervention group 1
timeFrame: Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Specific Proteins at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Specific Proteins at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Hormones at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Hormones at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Hormones at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Vitamin D-25OH at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Vitamin D-25OH at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Vitamin D-25OH at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Immunology at 2 months
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Immunology at 3.5 months control and intervention group 1
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Immunology at 5 months control and intervention group 1
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Muscular fitness at 5 months control and intervention group 1: isometric and isokinetic trunk flexor and extensor strength
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Muscular fitness at 3.5 months control and intervention group 1: isometric and isokinetic trunk flexor and extensor strength
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Muscular fitness at 2 months: isometric and isokinetic trunk flexor and extensor endurance/strength
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Muscular fitness at 5 months control and intervention group 1: cardio-respiratory fitness
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Muscular fitness at 3.5 months control and intervention group 1: cardio-respiratory fitness
timeFrame: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
measure: Change from baseline Muscular fitness at 2 months: cardio-respiratory fitness
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Muscular fitness at 5 months control and intervention group 1: upper body strength
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Muscular fitness at 3.5 months: upper body strength
timeFrame: Change from baseline at 3.5 months (Posttest minus Pretest)
measure: Change from baseline Muscular fitness at 2 months: upper body strength
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Muscular fitness at 5 months control and intervention group 1: lower body endurance
timeFrame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
measure: Change from baseline Muscular fitness at 3.5 months: lower body endurance
timeFrame: Change from baseline at 3.5 months (Posttest minus Pretest)
measure: Change from baseline Muscular fitness at 2 months: lower body endurance
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Muscular fitness at 2 months: The trunk muscle endurance
timeFrame: Change from baseline at 2 months (Posttest minus Pretest)
measure: Change from baseline Muscular fitness at 3.5 months: The trunk muscle endurance
timeFrame: Change from baseline at 3.5 months (Posttest minus Pretest)
measure: Change from baseline Muscular fitness at 5 months: The trunk muscle endurance
timeFrame: Change from baseline at 5 months (Retest minus Pretest)
Other outcomes:
Locations:
city: Granada
country: Spain
facility: iBS.Granada
Study officials:
References: