Multimodal Intervention in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project
- Conditions
- Pain, ChronicLow Back PainNeurologic ManifestationsBack PainBehavior, Health
- Interventions
- Other: Control groupBehavioral: Multimodal + Resistance Programs
- Registration Number
- NCT06114264
- Lead Sponsor
- IBS Granada
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Control group This group will not receive any treatment during the intervention period. Multimodal + Resistance Program Multimodal + Resistance Programs 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.
- Primary Outcome Measures
Name Time Method Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 3.5 months Change from baseline at 3.5 months (Posttest minus Pretest) It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.
Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 5 months Change from baseline at 5 months (Retest minus Pretest) It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.
Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 2 months Change from baseline at 2 months (Posttest minus Pretest) It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 3.5 months Change from baseline at 3.5 months (Posttest minus Pretest) It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Change from baseline Pressure pain threshold (PPT) in the lower back at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 2 months Change from baseline at 2 months (Posttest minus Pretest) It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.
Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 5 months Change from baseline at 5 months (Posttest minus Pretest) It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Change from baseline Pressure pain threshold (PPT) in the lower back at 2 months Change from baseline at 2 months (Posttest minus Pretest) It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
- Secondary Outcome Measures
Name Time Method Change from baseline physical activity and sedentary time at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA).
Change from baseline Gait parameters at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) Spatiotemporal gait parameters such as, double support (s) will be calculated using Optogait platform.
Change from baseline Gait parameters at 2 months control and intervention group 1 Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest) Spatiotemporal gait parameters such as, double support (s) will be calculated using Optogait platform.
Change from baseline Fat percentage at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) Will be measured by bioelectrical impedance analysis (InBody R20, Biospace)
Change from baseline Disability due to pain at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) 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 Pain intensity at 2 months Change from baseline at 2 months (Posttest minus Pretest) 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 Disability due to pain at 3.5 months Change from baseline at 3.5 months (Posttest minus Pretest) 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 Pain intensity at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) 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 Fat percentage at 2 months Change from baseline at 2 months (Posttest minus Pretest) Will be measured by bioelectrical impedance analysis (InBody R20, Biospace)
Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) They will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22).
Change from baseline Immunology at 2 months Change from baseline at 2 months (Posttest minus Pretest) It will be carried out with a blood draw. The General Immunology will include C3 and C4 complement (mg/dL)
Change from baseline Pain intensity at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) 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 physical activity and sedentary time at 2 months Change from baseline at 2 months (Posttest minus Pretest) They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA).
Change from baseline Gait parameters at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) Spatiotemporal gait parameters such as, double support (s) will be calculated using Optogait platform.
Change from baseline Fat percentage at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) Will be measured by bioelectrical impedance analysis (InBody R20, Biospace)
Change from baseline Health-related quality of life at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) 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 Depression severity at 2 months Change from baseline at 2 months (Posttest minus Pretest) 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 Depression severity at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) 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 Haemostasis at 2 months Change from baseline at 2 months (Posttest minus Pretest) It will be carried out with a blood draw. The Haemostasis will include prothrombin time (seconds)
Change from baseline Hormones at 2 months Change from baseline at 2 months (Posttest minus Pretest) It will be carried out with a blood draw. The Hormones will be cortisol (μg/dL).
Change from baseline Disability due to pain at 2 months Change from baseline at 2 months (Posttest minus Pretest) 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 Gait parameters at 2 months Change from baseline at 2 months (Posttest minus Pretest) Spatiotemporal gait parameters such as, gait speed (m/s) will be calculated using Optogait platform.
Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) They will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22).
Change from baseline Health-related quality of life at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) 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 Central sensitization at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) 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 Pain Catastrophyzing at 2 months Change from baseline at 2 months (Posttest minus Pretest) 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 Pain Catastrophyzing at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) 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 Anxiety state at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) 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 physical activity and sedentary time at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA).
Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 2 months Change from baseline at 2 months (Posttest minus Pretest) They will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22).
Change from baseline Depression severity at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) 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 Sleep duration and quality at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) 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 Health-related quality of life at 2 months Change from baseline at 2 months (Posttest minus Pretest) 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 Central sensitization at 2 months Change from baseline at 2 months (Posttest minus Pretest) 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 Pain Catastrophyzing at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) 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 Anxiety state at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) 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 Specific Proteins at 2 months Change from baseline at 2 months (Posttest minus Pretest) It will be carried out with a blood draw. The specific proteins will be reactive protein C (mg/L)
Change from baseline Specific Proteins at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) It will be carried out with a blood draw. The specific proteins will be interleukin 6 (pg/mL)
Change from baseline Muscular fitness at 3.5 months control and intervention group 1: cardio-respiratory fitness Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) It will be measured with the YMCA 3 minutes step test
Change from baseline Central sensitization at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) 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 Anxiety state at 2 months Change from baseline at 2 months (Posttest minus Pretest) 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 Haemostasis at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) It will be carried out with a blood draw. The Haemostasis will include prothrombin time (seconds)
Change from baseline Specific Proteins at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) It will be carried out with a blood draw. The specific proteins will be interleukin 6 (pg/mL)
Change from baseline Hormones at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) It will be carried out with a blood draw. The Hormones will be cortisol (μg/dL).
Change from baseline Vitamin D-25OH at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) Vitamin D-25OH (ng/mL) will be carried out with a blood draw.
Change from baseline Muscular fitness at 3.5 months control and intervention group 1: isometric and isokinetic trunk flexor and extensor strength Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) It will me measured with the electromechanic functional dynamometer (DYNASYSTEM, Granada, Spain)
Change from baseline Muscular fitness at 5 months control and intervention group 1: upper body strength Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) It will be measured with the handgrip strength test (TKK 5101 Grip-D dynamometer; Takei Scientific Instruments Co., Ltd., Tokyo, Japan).
Change from baseline Muscular fitness at 2 months: lower body endurance Change from baseline at 2 months (Posttest minus Pretest) It will be measured by the 30s chair stand test.
Change from baseline Sleep duration and quality at 2 months Change from baseline at 2 months (Posttest minus Pretest) 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 Specific Proteins at 3.5 months Change from baseline at 3.5 months (Posttest minus Pretest) It will be carried out with a blood draw. The specific proteins will be reactive protein C (mg/L)
Change from baseline Specific Proteins at 2 months control and intervention group 1 Change from baseline at 2 months control and intervention group 1 (Posttest minus Pretest) It will be carried out with a blood draw. The specific proteins will be interleukin 6 (pg/mL)
Change from baseline Vitamin D-25OH at 2 months Change from baseline at 2 months (Posttest minus Pretest) Vitamin D-25OH (ng/mL) will be carried out with a blood draw.
Change from baseline Immunology at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) It will be carried out with a blood draw. The General Immunology will include C3 and C4 complement (mg/dL)
Change from baseline Muscular fitness at 5 months control and intervention group 1: isometric and isokinetic trunk flexor and extensor strength Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) It will me measured with the electromechanic functional dynamometer (DYNASYSTEM, Granada, Spain)
Change from baseline Muscular fitness at 5 months control and intervention group 1: cardio-respiratory fitness Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) It will be measured with the YMCA 3 minutes step test
Change from baseline Muscular fitness at 3.5 months: upper body strength Change from baseline at 3.5 months (Posttest minus Pretest) It will be measured with the handgrip strength test (TKK 5101 Grip-D dynamometer; Takei Scientific Instruments Co., Ltd., Tokyo, Japan).
Change from baseline Sleep duration and quality at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) 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 Haemostasis at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) It will be carried out with a blood draw. The Haemostasis will include prothrombin time (seconds)
Change from baseline Hormones at 5 months control and intervention group 1 Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) It will be carried out with a blood draw. The Hormones will be cortisol (μg/dL).
Change from baseline Vitamin D-25OH at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) Vitamin D-25OH (ng/mL) will be carried out with a blood draw.
Change from baseline Muscular fitness at 2 months: upper body strength Change from baseline at 2 months (Posttest minus Pretest) It will be measured with the handgrip strength test (TKK 5101 Grip-D dynamometer; Takei Scientific Instruments Co., Ltd., Tokyo, Japan).
Change from baseline Muscular fitness at 3.5 months: lower body endurance Change from baseline at 3.5 months (Posttest minus Pretest) It will be measured by the 30s chair stand test.
Change from baseline Muscular fitness at 3.5 months: The trunk muscle endurance Change from baseline at 3.5 months (Posttest minus Pretest) It will be measured with the Biering-Sørensen test (seconds per minute) and the prone bridging test (seconds per minute).
Change from baseline Immunology at 3.5 months control and intervention group 1 Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest) It will be carried out with a blood draw. The General Immunology will include C3 and C4 complement (mg/dL)
Change from baseline Muscular fitness at 2 months: isometric and isokinetic trunk flexor and extensor endurance/strength Change from baseline at 2 months (Posttest minus Pretest) It will me measured with the electromechanic functional dynamometer (DYNASYSTEM, Granada, Spain)
Change from baseline Muscular fitness at 2 months: cardio-respiratory fitness Change from baseline at 2 months (Posttest minus Pretest) It will be measured with the YMCA 3 minutes step test
Change from baseline Muscular fitness at 5 months: The trunk muscle endurance Change from baseline at 5 months (Retest minus Pretest) It will be measured with the Biering-Sørensen test (seconds per minute) and the prone bridging test (seconds per minute).
Change from baseline Muscular fitness at 5 months control and intervention group 1: lower body endurance Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest) It will be measured by the 30s chair stand test.
Change from baseline Muscular fitness at 2 months: The trunk muscle endurance Change from baseline at 2 months (Posttest minus Pretest) It will be measured with the Biering-Sørensen test (seconds per minute) and the prone bridging test (seconds per minute).
Trial Locations
- Locations (1)
iBS.Granada
🇪🇸Granada, Spain