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

March 24, 2026 updated by: Víctor Segura Jiménez, IBS Granada

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain
        • IBS.Granada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise
The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks.
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)
Experimental: Exercise + mindfulness
The exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session).
Behavioral: 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
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Muscular fitness at 2 months: The trunk muscle strength/endurance
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline Pressure pain threshold (PPT) in the lower back at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: 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
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
It will be assessed with the Oswestry low back pain scale. The total score will be calculated summing the value of the 10 items and represented as percentage (%), where 0-20% means minimum functional limitation; 20%-40% moderate functional limitation; 40%-60% intense functional limitation; 60%-80% disability and more than 80% maximum functional limitation.
Change from baseline at 5 months (Retest minus Pretest)
Change from baseline Pain intensity at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
Patients will be instructed to indicate the intensity of pain they felt on a valid and reliable 10 cm long straight line marked with a score from 0 to 10
Change from baseline at 5 months (Retest minus Pretest)
Change from baseline Sedentary time and physical activity at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
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
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
will be assessed with the Short-Form Health Survey (SF-36). It contains 36 items grouped into 8 dimensions: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role, and mental health. The scores range from 0 to 100 in every dimension, where higher scores indicate better health.
Change from baseline at 5 months (Retest minus Pretest)
Change from baseline Central sensitization at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
The Central Sensitisation Inventory will be used. It is a self-report questionnaire designed to identify patients who have symptoms that may be related to central sensitisation. It presents 25 questions and the patient scores each answer on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitisation
Change from baseline at 5 months (Retest minus Pretest)
Change from baseline Pain Catastrophyzing at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
The Pain Catastrophizing Scale will be used to assess painful experiences and thoughts or feelings about pain. It contains 13 items on a 5-point scale. Higher score represents a more negative appraisal of pain.
Change from baseline at 5 months (Retest minus Pretest)
Change from baseline Depression severity at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
The Beck Depression Inventory-II will be used. It contains 21 items and the range of score is 0-63 with higher values indicating greater depression.
Change from baseline at 5 months (Retest minus Pretest)
Change from baseline Anxiety state at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
The State Trait Anxiety Inventory-I will be used to assess anxiety state (i.e., the level of current anxiety). It is a 20-item self-administered questionnaire and the range of score is 20-80, with higher score indicating a greater anxiety state.
Change from baseline at 5 months (Retest minus Pretest)
Change from baseline Sleep duration and quality at 2 months
Time Frame: Change from baseline at 2 months (Postest minus Retest)
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
Time Frame: Change from baseline at 5 months (Retest minus Pretest)
It will be assessed with the Pittsburgh Sleep Quality Index. It is composed of 19 questions, with four-point Likert scales (0-3), addressing seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction. The sleep quality global score is the sum of all components. Higher scores indicate worse sleep quality.
Change from baseline at 5 months (Retest minus Pretest)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IBS Granada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
European Social Fund
University Hospital Virgen de las Nieves

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IBS.Granada

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings