Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital Virgen de las Nieves | OTHER |
| European Social Fund | OTHER |
| Fundación Pública Andaluza para la Investigación Biomédica AndalucÃa Oriental | OTHER |
Not provided
Not provided
Not provided
Not provided
Chronic low back pain is among the most common health problems seen in primary care, and is responsible for disability and absenteeism in our country. In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP). Taking into consideration that multidimensional programs usually present more effectiveness reducing pain than unimodal programs, the current research investigates the role of unexplored multidimensional program (exercise and mindfulness) in NSCLBP. The primary aim of this project is to determine the effectiveness of a supervised exercise program (intervention 1) and a supervised exercise program + mindfulness (intervention 2) on pain, disability, trunk muscle endurance/strength, quality of life and gait parameters in patients with NSCLBP.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks. |
|
| Exercise + mindfulness | Experimental | The exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session). |
|
| Control | Other | The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | The exercise intervention will focus on working the core muscles, starting with low-intensity isometric contraction of the core muscles that stabilize the trunk; increasing intensity by performing functional tasks (phase 1: independent isometric contraction of transversus-abdominis and multifidus, phase 2: co-contraction and functional tasks of the deep trunk muscles; phase 3: functional task with load; phase 4: functional task with unstable surface) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Muscular fitness at 2 months: The trunk muscle strength/endurance | It will be measured with the Biering-Sørensen test and the plank test. | Change from baseline at 2 months (Postest minus Retest) |
| Change from baseline Muscular fitness at 5 months: The trunk muscle strength/endurance | It will be measured with the Biering-Sørensen test and the plank test. | Change from baseline at 5 months (Retest minus Pretest) |
| Change from baseline Muscular fitness at 2 months: lower body strength | It will be measured by the 30s chair stand test. Upper body strength (maximal isometric strength) will be measured with the handgrip strength test (TKK dynamometer). | Change from baseline at 2 months (Postest minus Retest) |
| Change from baseline Muscular fitness at 5 months: lower body strength | It will be measured by the 30s chair stand test. Upper body strength (maximal isometric strength) will be measured with the handgrip strength test (TKK dynamometer). | Change from baseline at 5 months (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; Takey, Tokyo, Japan dynamometer). | Change from baseline at 2 months (Postest minus Retest) |
| Change from baseline Muscular fitness at 5 months: upper body strength | It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer). |
Not provided
| 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 (Postest minus Retest) |
| Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IBS.Granada | Granada | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D064866 | Mindfulness |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Exercise + mindfulness | Behavioral | 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 (using appreciative inquiry) and a Mindfulness practice. Participants will be provided with workbooks, audios with guided meditations, and instructions for practice at home. In addition, the Exercise + mindfulness intervention will include the exercise program described in the exercise intervention. |
|
| Control group | Other | The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks. |
|
| Change from baseline at 5 months (Retest minus Pretest) |
It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA). |
| Change from baseline at 5 months (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 (Postest minus Retest) |
| Change from baseline Disability due to pain at 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 5 months (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 (Postest minus Retest) |
| Change from baseline Pain intensity at 5 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 5 months (Retest minus Pretest) |
| Change from baseline Sedentary time and physical activity at 2 months | They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA). | Change from baseline at 2 months (Postest minus Retest) |
| Change from baseline Sedentary time and physical activity at 5 months | They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA). | Change from baseline at 5 months (Retest minus Pretest) |
| Change from baseline Gait parameters at 2 months | Spatiotemporal parameters (e.g., cadence, stance and support times, step length and stride width) will be calculated using Optogait. | Change from baseline at 2 months (Postest minus Retest) |
| Change from baseline Gait parameters at 5 months | Spatiotemporal parameters (e.g., cadence, stance and support times, step length and stride width) will be calculated using Optogait. | Change from baseline at 5 months (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 (Postest minus Retest) |
| Change from baseline Fat percentage at 5 months | will be measured by bioelectrical impedance analysis (InBody R20, Biospace) | Change from baseline at 5 months (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 (Postest minus Retest) |
| Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 5 months | they will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22). | Change from baseline at 5 months (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 (Postest minus Retest) |
| Change from baseline Health-related quality of life at 5 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 5 months (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 (Postest minus Retest) |
| Change from baseline Central sensitization at 5 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 5 months (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 (Postest minus Retest) |
| Change from baseline Pain Catastrophyzing at 5 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 5 months (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 (Postest minus Retest) |
| Change from baseline Depression severity at 5 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 5 months (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 (Postest minus Retest) |
| Change from baseline Anxiety state at 5 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 5 months (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 (Postest minus Retest) |
| Change from baseline Sleep duration and quality at 5 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 5 months (Retest minus Pretest) |
| D001519 | Behavior |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |