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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neurologic Manifestations; Back Pain; Low Back Pain; Pain, Chronic; Behavior, Health
• Intervention / Treatment: Other: Control group; Behavioral: Multimodal + Resistance Programs

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18012
    • iBS.Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control Group; This group will not receive any treatment during the intervention period.	Other: Control group; No experimental intervention. The group will receive the same multimodal intervention as the experimental group when the experimental period is over.
Experimental: Multimodal + Resistance Program; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Pressure pain threshold (PPT) in the lower back at 2 months	It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 2 months	It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 3.5 months	It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.	Change from baseline at 3.5 months (Posttest minus Pretest)
Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 5 months	It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.	Change from baseline at 5 months (Retest minus Pretest)
Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 2 months	It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).	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	It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).	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	It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).	Change from baseline at 5 months (Posttest minus Pretest)
Change from baseline Pressure pain threshold (PPT) in the lower back at 3.5 months control and intervention group 1	It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months control and intervention group 1	It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Muscular fitness at 2 months: The trunk muscle endurance	It will be measured with the Biering-Sørensen test (seconds per minute) and the prone bridging test (seconds per minute).	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Muscular fitness at 3.5 months: The trunk muscle endurance	It will be measured with the Biering-Sørensen test (seconds per minute) and the prone bridging test (seconds per minute).	Change from baseline at 3.5 months (Posttest minus Pretest)
Change from baseline Muscular fitness at 5 months: The trunk muscle endurance	It will be measured with the Biering-Sørensen test (seconds per minute) and the prone bridging test (seconds per minute).	Change from baseline at 5 months (Retest minus Pretest)
Change from baseline Muscular fitness at 2 months: lower body endurance	It will be measured by the 30s chair stand test.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Muscular fitness at 3.5 months: lower body endurance	It will be measured by the 30s chair stand test.	Change from baseline at 3.5 months (Posttest minus Pretest)
Change from baseline Muscular fitness at 5 months control and intervention group 1: lower body endurance	It will be measured by the 30s chair stand test.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Muscular fitness at 2 months: upper body strength	It will be measured with the handgrip strength test (TKK 5101 Grip-D dynamometer; Takei Scientific Instruments Co., Ltd., Tokyo, Japan).	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Muscular fitness at 3.5 months: upper body strength	It will be measured with the handgrip strength test (TKK 5101 Grip-D dynamometer; Takei Scientific Instruments Co., Ltd., Tokyo, Japan).	Change from baseline at 3.5 months (Posttest minus Pretest)
Change from baseline Muscular fitness at 5 months control and intervention group 1: upper body strength	It will be measured with the handgrip strength test (TKK 5101 Grip-D dynamometer; Takei Scientific Instruments Co., Ltd., Tokyo, Japan).	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Muscular fitness at 2 months: cardio-respiratory fitness	It will be measured with the YMCA 3 minutes step test	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Muscular fitness at 3.5 months control and intervention group 1: cardio-respiratory fitness	It will be measured with the YMCA 3 minutes step test	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Muscular fitness at 5 months control and intervention group 1: cardio-respiratory fitness	It will be measured with the YMCA 3 minutes step test	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Muscular fitness at 2 months: isometric and isokinetic trunk flexor and extensor endurance/strength	It will me measured with the electromechanic functional dynamometer (DYNASYSTEM, Granada, Spain)	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Muscular fitness at 3.5 months control and intervention group 1: isometric and isokinetic trunk flexor and extensor strength	It will me measured with the electromechanic functional dynamometer (DYNASYSTEM, Granada, Spain)	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Muscular fitness at 5 months control and intervention group 1: isometric and isokinetic trunk flexor and extensor strength	It will me measured with the electromechanic functional dynamometer (DYNASYSTEM, Granada, Spain)	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Disability due to pain at 2 months	It will be assessed with the Oswestry low back pain scale. The total score will be calculated summing the value of the 10 items and represented as percentage (%), where 0-20% means minimum functional limitation; 20%-40% moderate functional limitation; 40%-60% intense functional limitation; 60%-80% disability and more than 80% maximum functional limitation.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Disability due to pain at 3.5 months	It will be assessed with the Oswestry low back pain scale. The total score will be calculated summing the value of the 10 items and represented as percentage (%), where 0-20% means minimum functional limitation; 20%-40% moderate functional limitation; 40%-60% intense functional limitation; 60%-80% disability and more than 80% maximum functional limitation.	Change from baseline at 3.5 months (Posttest minus Pretest)
Change from baseline Disability due to pain at 5 months control and intervention group 1	It will be assessed with the Oswestry low back pain scale. The total score will be calculated summing the value of the 10 items and represented as percentage (%), where 0-20% means minimum functional limitation; 20%-40% moderate functional limitation; 40%-60% intense functional limitation; 60%-80% disability and more than 80% maximum functional limitation.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Pain intensity at 2 months	Patients will be instructed to indicate the intensity of pain they felt on a valid and reliable 10 cm long straight line marked with a score from 0 to 10.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Pain intensity at 3.5 months control and intervention group 1	Patients will be instructed to indicate the intensity of pain they felt on a valid and reliable 10 cm long straight line marked with a score from 0 to 10.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Pain intensity at 5 months control and intervention group 1	Patients will be instructed to indicate the intensity of pain they felt on a valid and reliable 10 cm long straight line marked with a score from 0 to 10.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline physical activity and sedentary time at 2 months	They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA).	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline physical activity and sedentary time at 3.5 months control and intervention group 1	They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA).	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline physical activity and sedentary time at 5 months control and intervention group 1	They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA).	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Gait parameters at 2 months	Spatiotemporal gait parameters such as, gait speed (m/s) will be calculated using Optogait platform.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Gait parameters at 3.5 months control and intervention group 1	Spatiotemporal gait parameters such as, gait speed (m/s) will be calculated using Optogait platform.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Gait parameters at 5 months control and intervention group 1	Spatiotemporal gait parameters such as, gait speed (m/s) will be calculated using Optogait platform.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Gait parameters at 2 months control and intervention group 1	Spatiotemporal gait parameters such as, stride length (cm) will be calculated using Optogait platform.	Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Gait parameters at 3.5 months control and intervention group 1	Spatiotemporal gait parameters such as, stride length (cm) will be calculated using Optogait platform.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Gait parameters at 5 months control and intervention group 1	Spatiotemporal gait parameters such as, stride length (cm) will be calculated using Optogait platform.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Gait parameters at 2 months control and intervention group 1	Spatiotemporal gait parameters such as, load response (gr/cm^2) will be calculated using Optogait platform.	Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Gait parameters at 3.5 months control and intervention group 1	Spatiotemporal gait parameters such as, load response (gr/cm^2) will be calculated using Optogait platform.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Gait parameters at 5 months control and intervention group 1	Spatiotemporal gait parameters such as, load response (gr/cm^2) will be calculated using Optogait platform.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Gait parameters at 2 months control and intervention group 1	Spatiotemporal gait parameters such as, double support (s) will be calculated using Optogait platform.	Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Gait parameters at 3.5 months control and intervention group 1	Spatiotemporal gait parameters such as, double support (s) will be calculated using Optogait platform.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Gait parameters at 5 months control and intervention group 1	Spatiotemporal gait parameters such as, double support (s) will be calculated using Optogait platform.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Fat percentage at 2 months	Will be measured by bioelectrical impedance analysis (InBody R20, Biospace)	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Fat percentage at 3.5 months control and intervention group 1	Will be measured by bioelectrical impedance analysis (InBody R20, Biospace)	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Fat percentage at 5 months control and intervention group 1	Will be measured by bioelectrical impedance analysis (InBody R20, Biospace)	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 2 months	They will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22).	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 3.5 months control and intervention group 1	They will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22).	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 5 months control and intervention group 1	They will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22).	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Health-related quality of life at 2 months	Will be assessed with the Short-Form Health Survey (SF-36). It contains 36 items grouped into 8 dimensions: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role, and mental health. The scores range from 0 to 100 in every dimension, where higher scores indicate better health.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Health-related quality of life at 3.5 months control and intervention group 1	Will be assessed with the Short-Form Health Survey (SF-36). It contains 36 items grouped into 8 dimensions: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role, and mental health. The scores range from 0 to 100 in every dimension, where higher scores indicate better health.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Health-related quality of life at 5 months control and intervention group 1	Will be assessed with the Short-Form Health Survey (SF-36). It contains 36 items grouped into 8 dimensions: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role, and mental health. The scores range from 0 to 100 in every dimension, where higher scores indicate better health.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Central sensitization at 2 months	The Central Sensitisation Inventory will be used. It is a self-report questionnaire designed to identify patients who have symptoms that may be related to central sensitisation. It presents 25 questions and the patient scores each answer on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitisation.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Central sensitization at 3.5 months control and intervention group 1	The Central Sensitisation Inventory will be used. It is a self-report questionnaire designed to identify patients who have symptoms that may be related to central sensitisation. It presents 25 questions and the patient scores each answer on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitisation.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Central sensitization at 5 months control and intervention group 1	The Central Sensitisation Inventory will be used. It is a self-report questionnaire designed to identify patients who have symptoms that may be related to central sensitisation. It presents 25 questions and the patient scores each answer on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitisation.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Pain Catastrophyzing at 2 months	The Pain Catastrophizing Scale will be used to assess painful experiences and thoughts or feelings about pain. It contains 13 items on a 5-point scale. Higher score represents a more negative appraisal of pain.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Pain Catastrophyzing at 3.5 months control and intervention group 1	The Pain Catastrophizing Scale will be used to assess painful experiences and thoughts or feelings about pain. It contains 13 items on a 5-point scale. Higher score represents a more negative appraisal of pain.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Pain Catastrophyzing at 5 months control and intervention group 1	The Pain Catastrophizing Scale will be used to assess painful experiences and thoughts or feelings about pain. It contains 13 items on a 5-point scale. Higher score represents a more negative appraisal of pain.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Depression severity at 2 months	The Beck Depression Inventory-II will be used. It contains 21 items and the range of score is 0-63 with higher values indicating greater depression.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Depression severity at 3.5 months control and intervention group 1	The Beck Depression Inventory-II will be used. It contains 21 items and the range of score is 0-63 with higher values indicating greater depression.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Depression severity at 5 months control and intervention group 1	The Beck Depression Inventory-II will be used. It contains 21 items and the range of score is 0-63 with higher values indicating greater depression.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Anxiety state at 2 months	The State Trait Anxiety Inventory-I will be used to assess anxiety state (i.e., the level of current anxiety). It is a 20-item self-administered questionnaire and the range of score is 20-80, with higher score indicating a greater anxiety state.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Anxiety state at 3.5 months control and intervention group 1	The State Trait Anxiety Inventory-I will be used to assess anxiety state (i.e., the level of current anxiety). It is a 20-item self-administered questionnaire and the range of score is 20-80, with higher score indicating a greater anxiety state.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Anxiety state at 5 months control and intervention group 1	The State Trait Anxiety Inventory-I will be used to assess anxiety state (i.e., the level of current anxiety). It is a 20-item self-administered questionnaire and the range of score is 20-80, with higher score indicating a greater anxiety state.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Sleep duration and quality at 2 months	It will be assessed with the Pittsburgh Sleep Quality Index. It is composed of 19 questions, with four-point Likert scales (0-3), addressing seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction. The sleep quality global score is the sum of all components. Higher scores indicate worse sleep quality.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Sleep duration and quality at 3.5 months control and intervention group 1	It will be assessed with the Pittsburgh Sleep Quality Index. It is composed of 19 questions, with four-point Likert scales (0-3), addressing seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction. The sleep quality global score is the sum of all components. Higher scores indicate worse sleep quality.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Sleep duration and quality at 5 months control and intervention group 1	It will be assessed with the Pittsburgh Sleep Quality Index. It is composed of 19 questions, with four-point Likert scales (0-3), addressing seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction. The sleep quality global score is the sum of all components. Higher scores indicate worse sleep quality.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Haemostasis at 2 months	It will be carried out with a blood draw. The Haemostasis will include prothrombin time (seconds)	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Haemostasis at 3.5 months control and intervention group 1	It will be carried out with a blood draw. The Haemostasis will include prothrombin time (seconds)	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Haemostasis at 5 months control and intervention group 1	It will be carried out with a blood draw. The Haemostasis will include prothrombin time (seconds)	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Specific Proteins at 2 months	It will be carried out with a blood draw. The specific proteins will be reactive protein C (mg/L)	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Specific Proteins at 3.5 months	It will be carried out with a blood draw. The specific proteins will be reactive protein C (mg/L)	Change from baseline at 3.5 months (Posttest minus Pretest)
Change from baseline Specific Proteins at 5 months control and intervention group 1	It will be carried out with a blood draw. The specific proteins will be reactive protein C (mg/L)	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Specific Proteins at 2 months control and intervention group 1	It will be carried out with a blood draw. The specific proteins will be interleukin 6 (pg/mL)	Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Specific Proteins at 3.5 months control and intervention group 1	It will be carried out with a blood draw. The specific proteins will be interleukin 6 (pg/mL)	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Specific Proteins at 5 months control and intervention group 1	It will be carried out with a blood draw. The specific proteins will be interleukin 6 (pg/mL)	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Hormones at 2 months	It will be carried out with a blood draw. The Hormones will be cortisol (μg/dL).	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Hormones at 3.5 months control and intervention group 1	It will be carried out with a blood draw. The Hormones will be cortisol (μg/dL).	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Hormones at 5 months control and intervention group 1	It will be carried out with a blood draw. The Hormones will be cortisol (μg/dL).	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Vitamin D-25OH at 2 months	Vitamin D-25OH (ng/mL) will be carried out with a blood draw.	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Vitamin D-25OH at 3.5 months control and intervention group 1	Vitamin D-25OH (ng/mL) will be carried out with a blood draw.	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Vitamin D-25OH at 5 months control and intervention group 1	Vitamin D-25OH (ng/mL) will be carried out with a blood draw.	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Immunology at 2 months	It will be carried out with a blood draw. The General Immunology will include C3 and C4 complement (mg/dL)	Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Immunology at 3.5 months control and intervention group 1	It will be carried out with a blood draw. The General Immunology will include C3 and C4 complement (mg/dL)	Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Immunology at 5 months control and intervention group 1	It will be carried out with a blood draw. The General Immunology will include C3 and C4 complement (mg/dL)	Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)

Collaborators and Investigators

• Sponsor: IBS Granada
• Collaborators: Instituto de Salud Carlos III; University Hospital Virgen de las Nieves

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pain; exercise; mindfulness; education; strength; behaviour change
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Back Pain; Low Back Pain; Chronic Pain; Neurologic Manifestations
• Other Study ID Numbers: iBSGranada

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No