Exercise and Mindfulness in Patients With Non-specific Chronic Low Back Pain: The BACKFIT Project

Low Back Pain Clinical Trial

Official title:

Multidimensional Approach (Exercise and Mindfulness) for Health Improvement in Patients With Non-specific Chronic Low Back Pain: The BackFit Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05443880
• Other study ID #: IBS.Granada
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: IBS Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Be previously diagnosed with NSCLBP pain by a healthcare professional according to the criteria established by O'Sullivan et al.

• 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 between 18 and 65 years old.

Exclusion Criteria:

• Having spondylolysis, spondylolisthesis, canal stenosis, degenerative disc disease, and/or disc herniation, tumor, trauma or fracture of the lumbar and lower limbs, Cauda equina syndrome, and radicular leg pain (given that spine degeneration issues are commonly present in asymptomatic individuals and increase with age, only serious lumbar structural disorders were considered).

• Having lumbar surgery as source of pain.

• 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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Exercise
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)
• Exercise + mindfulness
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.

Other:
• Control group
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.

Locations

Country	Name	City	State
Spain	IBS.Granada	Granada

Sponsors (4)

Lead Sponsor	Collaborator
IBS Granada	European Social Fund, ISCIII, University Hospital Virgen de las Nieves

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months	It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).	Change from baseline at 5 months (Retest minus Pretest)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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).	Change from baseline at 5 months (Retest minus Pretest)