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

Primary Purpose

Low Back Pain

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Exercise + mindfulness
Control group
Sponsored by
IBS Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Exercise, mindfulness, sedentary behaviour, strength, pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  • Be under 20 years or over 65 years old.
  • Having acute or terminal illness.
  • Having medical prescription that prevents the performance of the tests.
  • Having injury or circumstance that makes it impossible to perform the tests correctly.
  • Having other physical or mental illness that prevents participating in the intervention.

Sites / Locations

  • IBS.Granada

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Exercise

Exercise + mindfulness

Control

Arm Description

The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks.

The exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session).

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

Outcomes

Primary Outcome Measures

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 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 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 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 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 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).

Secondary Outcome Measures

Full Information

First Posted
June 2, 2022
Last Updated
January 20, 2023
Sponsor
IBS Granada
Collaborators
University Hospital Virgen de las Nieves, ISCIII, European Social Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05443880
Brief Title
Exercise and Mindfulness in Patients With Non-specific Chronic Low Back Pain: The BACKFIT Project
Official Title
Multidimensional Approach (Exercise and Mindfulness) for Health Improvement in Patients With Non-specific Chronic Low Back Pain: The BackFit Project
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IBS Granada
Collaborators
University Hospital Virgen de las Nieves, ISCIII, European Social Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Exercise, mindfulness, sedentary behaviour, strength, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks.
Arm Title
Exercise + mindfulness
Arm Type
Experimental
Arm Description
The exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session).
Arm Title
Control
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Exercise + mindfulness
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Muscular fitness at 2 months: The trunk muscle strength/endurance
Description
It will be measured with the Biering-Sørensen test and the plank test.
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Muscular fitness at 5 months: The trunk muscle strength/endurance
Description
It will be measured with the Biering-Sørensen test and the plank test.
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Muscular fitness at 2 months: lower body strength
Description
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).
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Muscular fitness at 5 months: lower body strength
Description
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).
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Muscular fitness at 2 months: upper body strength
Description
It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer).
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Muscular fitness at 5 months: upper body strength
Description
It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer).
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Other Pre-specified Outcome Measures:
Title
Change from baseline Pressure pain threshold (PPT) in the lower back at 2 months
Description
It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months
Description
It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Disability due to pain at 2 months
Description
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.
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Disability due to pain at 5 months
Description
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.
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Pain intensity at 2 months
Description
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
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Pain intensity at 5 months
Description
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
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Sedentary time and physical activity at 2 months
Description
They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA).
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Sedentary time and physical activity at 5 months
Description
They will be recorded through GT3X+ Accelerometer (Actigraph, Inc., Fort Walton Beach, FL, USA).
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Gait parameters at 2 months
Description
Spatiotemporal parameters (e.g., cadence, stance and support times, step length and stride width) will be calculated using Optogait.
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Gait parameters at 5 months
Description
Spatiotemporal parameters (e.g., cadence, stance and support times, step length and stride width) will be calculated using Optogait.
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Fat percentage at 2 months
Description
will be measured by bioelectrical impedance analysis (InBody R20, Biospace)
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Fat percentage at 5 months
Description
will be measured by bioelectrical impedance analysis (InBody R20, Biospace)
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 2 months
Description
they will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22).
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline weight (kg) and height (cm) to report BMI in kg/m^2 at 5 months
Description
they will be measured by bioelectrical impedance analysis (InBody R20, Biospace) and height rod (Seca 22).
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Health-related quality of life at 2 months
Description
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.
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Health-related quality of life at 5 months
Description
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.
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Central sensitization at 2 months
Description
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
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Central sensitization at 5 months
Description
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
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Pain Catastrophyzing at 2 months
Description
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.
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Pain Catastrophyzing at 5 months
Description
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.
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Depression severity at 2 months
Description
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.
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Depression severity at 5 months
Description
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.
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Anxiety state at 2 months
Description
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.
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Anxiety state at 5 months
Description
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.
Time Frame
Change from baseline at 5 months (Retest minus Pretest)
Title
Change from baseline Sleep duration and quality at 2 months
Description
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.
Time Frame
Change from baseline at 2 months (Postest minus Retest)
Title
Change from baseline Sleep duration and quality at 5 months
Description
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.
Time Frame
Change from baseline at 5 months (Retest minus Pretest)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
IBS.Granada
City
Granada
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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