Pain, ChronicNCT06114264
Multimodal Intervention in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project
A study testing Multimodal + Resistance Programs in people with Pain, Chronic and Neurologic Manifestations, run by IBS Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic, Neurologic Manifestations, Back Pain
- What is being tested?
- Multimodal + Resistance Programs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Multimodal + Resistance Programs, Control group
- Keywords
- exercise, behaviour change, education, mindfulness, pain, strength
- Medical subject headings
- Chronic Pain, Neurologic Manifestations, Back Pain, Low Back Pain, Health Behavior, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal + Resistance ProgramsBehavioural
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.
Control groupOther
No experimental intervention. The group will receive the same multimodal intervention as the experimental group when the experimental period is over.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | This group will not receive any treatment during the intervention period. Receives: Other: Control group |
| Multimodal + Resistance Program | Experimental | 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. Receives: Behavioral: Multimodal + Resistance Programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Change from baseline at 5 months (Posttest minus Pretest)
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).
Measured: Change from baseline at 2 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).
Measured: 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).
Measured: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Secondary outcomes (78)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Change from baseline at 5 months control and intervention group 1 (Retest 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)
Measured: Change from baseline at 5 months control and intervention group 1 (Retest 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)
Measured: Change from baseline at 3.5 months control and intervention group 1 (Posttest 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)
Measured: Change from baseline at 2 months (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
Measured: Change from baseline at 5 months control and intervention group 1 (Retest 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
Measured: Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)
Change from baseline Muscular fitness at 2 months: cardio-respiratory fitness
It will be measured with the YMCA 3 minutes step test
Measured: Change from baseline at 2 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).
Measured: Change from baseline at 5 months control and intervention group 1 (Retest 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).
Measured: Change from baseline at 3.5 months (Posttest 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).
Measured: Change from baseline at 2 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.
Measured: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Muscular fitness at 3.5 months: lower body endurance
It will be measured by the 30s chair stand test.
Measured: Change from baseline at 3.5 months (Posttest minus Pretest)
Change from baseline Muscular fitness at 2 months: lower body endurance
It will be measured by the 30s chair stand test.
Measured: Change from baseline at 2 months (Posttest minus Pretest)
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).
Measured: 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).
Measured: 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).
Measured: Change from baseline at 5 months (Retest minus Pretest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jan 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBS Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Víctor Segura Jiménez, IBS Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114264
- Sponsor's protocol ID
- iBSGranada
- Status last verified
- Mar 2026
- First submitted
- 10 Oct 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsiarleston G, Lopez-Fernandez MD, Pavon-Munoz R, Aguilera-Garcia I, Lopez-Corchon M, Delgado-Fernandez M, Castellote-Caballero MY, Donoso B, Mesa-Ruiz AM, Pozuelo-Calvo R, Rios-Ortiz AM, Alvarez-Corral G, Marin-Jimenez N, Martinez-Garcia D, Chirosa Rios IJ, Segura-Jimenez V. Multimodal intervention based on physical exercise, mindfulness, behaviour change and education to improve pain and health in patients with chronic primary low back pain: a study protocol of the HEALTHYBACK randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Nov 21;10(4):e002188. doi: 10.1136/bmjsem-2024-002188. eCollection 2024.
PubMed 39610994
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Intervention to Improve Pain and Health in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project
- ClinicalTrials.gov ID
- NCT06114264
- Acronym / sponsor ID
- iBSGranada
- Keywords
- exercise, behaviour change, education, mindfulness, pain, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- IBS GranadaUniversity, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Instituto de Salud Carlos III
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Other: Control groupThis group will not receive any treatment during the intervention period. |
| Multimodal + Resistance Program | Experimental | Behavioral: Multimodal + Resistance ProgramsMultimodal 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal + Resistance ProgramsExercise: 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. | Behavioural | Multimodal + Resistance Program |
| Control groupNo experimental intervention. The group will receive the same multimodal intervention as the experimental group when the experimental period is over. | Other | Control Group |
Primary outcome
Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 2 months
Time frame: 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 Conditioned Pain Modulation (CPM) in the lower back at 3.5 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Temporal Sumation of Pain (TSP) in the lower back at 5 months
Time frame: 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
Time frame: 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 Pressure pain threshold (PPT) in the lower back at 3.5 months control and intervention group 1
Time frame: 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 Pressure pain threshold (PPT) in the lower back at 5 months control and intervention group 1
Time frame: 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).
78 secondary outcomes
Change from baseline Disability due to pain at 2 months
Time frame: Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Disability due to pain at 3.5 months
Time frame: 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
Time frame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Pain intensity at 2 months
Time frame: Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Pain intensity at 3.5 months control and intervention group 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Gait parameters at 2 months
Time frame: Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Gait parameters at 3.5 months control and intervention group 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Fat percentage at 2 months
Time frame: Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Fat percentage at 3.5 months control and intervention group 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Central sensitization at 2 months
Time frame: Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Central sensitization at 3.5 months control and intervention group 1
Time frame: 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
Time frame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Pain Catastrophyzing at 2 months
Time frame: Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Pain Catastrophyzing at 3.5 months control and intervention group 1
Time frame: 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
Time frame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Depression severity at 2 months
Time frame: Change from baseline at 2 months (Posttest minus Pretest)
Change from baseline Depression severity at 3.5 months control and intervention group 1
Time frame: 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
Time frame: Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)
Change from baseline Anxiety state at 2 months
Time frame: Change from baseline at 2 months (Posttest minus Pretest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 39610994Tsiarleston G, Lopez-Fernandez MD, Pavon-Munoz R, Aguilera-Garcia I, Lopez-Corchon M, Delgado-Fernandez M, Castellote-Caballero MY, Donoso B, Mesa-Ruiz AM, Pozuelo-Calvo R, Rios-Ortiz AM, Alvarez-Corral G, Marin-Jimenez N, Martinez-Garcia D, Chirosa Rios IJ, Segura-Jimenez V. Multimodal intervention based on physical exercise, mindfulness, behaviour change and education to improve pain and health in patients with chronic primary low back pain: a study protocol of the HEALTHYBACK randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Nov 21;10(4):e002188. doi: 10.1136/bmjsem-2024-002188. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Pain, Chronic
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
RecruitingPhase 3
Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radiculopathy
Recruiting
Light Bulb Stimuli to Reduce Chronic Pain
Fibromyalgia, Musculoskeletal Pain
Active, not recruiting
Probiotics for Inflammation in Pediatric Chronic Pain
Chronic Pain, Body Mass Index >=85th Percentile
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal + Resistance Programs in people with Pain, Chronic and Neurologic Manifestations, run by IBS Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 2 months (time frame: Change from baseline at 2 months (Posttest minus Pretest)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06114264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.