Low Back PainNCT05443880
Exercise and Mindfulness in Patients With Non-specific Chronic Low Back Pain: The BACKFIT Project
A study testing Exercise and Exercise + mindfulness in people with Low Back Pain, run by IBS Granada at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise and Exercise + mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 31 Dec 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 20 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 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Being tested
- Exercise, Exercise + mindfulness, Control group
- Keywords
- Exercise, mindfulness, sedentary behaviour, strength, pain
- Medical subject headings
- Low Back Pain, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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 + mindfulnessBehavioural
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks. Receives: Behavioral: Exercise |
| 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). Receives: Behavioral: Exercise + mindfulness |
| 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 Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
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 posted5 Jul 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBS Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, European Social Fund, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Responsible party
- Principal investigator, Víctor Segura Jiménez, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443880
- Sponsor's protocol ID
- IBS.Granada
- Status last verified
- Mar 2026
- First submitted
- 2 Jun 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Multidimensional Approach (Exercise and Mindfulness) for Health Improvement in Patients With Non-specific Chronic Low Back Pain: The BackFit Project
- ClinicalTrials.gov ID
- NCT05443880
- Acronym / sponsor ID
- IBS.Granada
- Conditions
- Low Back Pain
- Keywords
- Exercise, mindfulness, sedentary behaviour, strength, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- IBS GranadaUniversity, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, European Social Fund, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Jul 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseThe exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks. |
| Exercise + mindfulness | Experimental | Behavioral: Exercise + mindfulnessThe exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session). |
| Control | Other | Other: Control groupThe 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| ExerciseThe 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) | Behavioural | Exercise |
| Exercise + mindfulnessThe 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. | Behavioural | Exercise + mindfulness |
| Control groupThe 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 |
Primary outcome
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 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 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 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 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 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).
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.
- Individual participant dataSharing planned: No
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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 Exercise and Exercise + mindfulness in people with Low Back Pain, 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 6 inclusion and 6 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. 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 Muscular fitness at 2 months: The trunk muscle strength/endurance (time frame: Change from baseline at 2 months (Postest minus Retest)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.