People With Chronic Low Back PainMyBackExerciseNCT07745465
Self-Selected Versus Physiotherapist-Prescribed Resistance Training Program In People With Chronic Low Back Pain
A study testing Experimental group in people with People With Chronic Low Back Pain, run by University of Cadiz.
Trial summary
Chronic low back pain is a public health issue affecting over 20% of the Spanish population, causing disability, reduced quality of life, and work absenteeism. Over the past decades, the benefits of physical exercise for improving symptoms in patients with chronic low back pain have been studied. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- People With Chronic Low Back Pain
- What is being tested?
- Experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants aged 18-65 years b) Low back pain, with or without referred pain to the lower limb, persisting for ≥12 weeks c) Not currently engaged in a regular structured exercise programme d) Sufficient cognitive and communication abilities to complete the assessment scales and participate in the study intervention Exclusion Criteria
- Lumbar radiculopathy or radicular pain syndrome, defined by clinical signs of nerve root involvement (e.g., dermatomal pain, neurological deficits, or positive neurodynamic tests)
- Serious spinal or non-spinal pathology explaining low back pain, identified through clinical assessment (e.g., malignancy, vertebral fracture, spinal infection, cauda equina syndrome, inflammatory spinal disease, vascular, visceral or other serious causes).
- Medical contraindications to exercise, as determined by the treating physician The presence of lumbar degenerative imaging findings (e.g., degenerative disc disease, lumbar spondylosis, facet joint osteoarthritis, or Modic changes) will not constitute an exclusion criterion, provided that the clinical presentation is consistent with chronic low back pain.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of a Self-Selected Resistance Training Program Compared With a Physiotherapist-Prescribed Resistance Training Program in People With Chronic Low Back Pain (MyBack Exercise): A Randomized Control Pilot Study
Chronic low back pain is a public health issue affecting over 20% of the Spanish population, causing disability, reduced quality of life, and work absenteeism. Over the past decades, the benefits of physical exercise for improving symptoms in patients with chronic low back pain have been studied. Exercise has also been shown to improve quality of life, general health, self-efficacy, and fear of pain, regardless of pathology. Research on the effect of physical exercise in chronic low back pain patients has shown promising results. Therefore, the therapeutic exercise program proposed in this study may help participants adopt healthy habits that positively impact their quality of life.
This will be a clinical trial in patients with chronic low back pain. The main purpose of the study is to evaluate the efficacy of a self-selected resistance training program versus physiotherapist-prescribed exercises in improving pain intensity and disability in adults with chronic low back pain. Secondary objectives include evaluating differences between the two groups after 12 weeks in treatment satisfaction, degree of compliance, kinesiophobia, self-efficacy, muscle endurance, and lumbar electromyographic activity.
Read more
If you agree to participate, a member of the research team experienced in exercise programs for chronic low back pain will instruct you on how to perform the program. The follow-up study will include 34 participants randomly assigned to two groups: one group performing self-selected resistance exercises, and one group performing physiotherapist-prescribed exercises. The study will last 12 weeks, assessing your condition at the start and end of the study. You will complete questionnaires on pain intensity (Numerical Pain Rating Scale, NPRS), disability (Oswestry Disability Index, ODI), treatment satisfaction (CRES-4), adherence to treatment, kinesiophobia (TSK-11), self-efficacy (Pain Self-Efficacy Questionnaire, PSEQ), muscle endurance (Biering-Sørensen test), and surface electromyographic activity of the erector spinae (longissimus) muscle (sEMG-ESL) using the mDurance® device.
POTENTIAL BENEFITS AND RISKS OF PARTICIPATION Expected direct benefits of participation may include improvements in pain intensity, disability, treatment satisfaction, adherence to therapeutic exercise, kinesiophobia, self-efficacy, muscle endurance, and electromyographic activity.
However, it is possible that you may not experience any personal benefit. The information obtained will contribute to scientific knowledge about CLBP and may help others in the future.
ALTERNATIVE TREATMENTS Chronic low back pain is a pathological entity with extensive study, which can present different conservative therapeutic options, such as psychological therapy, regular physical exercise and the adoption of healthy habits.
COMPENSATION Participation in this study will not incur any costs for you. OTHER RELEVANT INFORMATION Any new information discovered during your participation that may affect your willingness to participate in the study will be communicated to you by your doctor as soon as possible.
If you decide to withdraw your consent to participate in this study, no new data will be added to the database, and if samples have already been collected, you may request the destruction of all previously obtained, identifiable samples to avoid further analysis.
You should also be aware that you may be excluded from the study if the sponsor or researchers deem it necessary, either for safety reasons or because they believe you are not complying with the established procedures.
In either case, you will receive a clear explanation of the reason for your withdrawal from the study. The sponsor may suspend the study for any of the reasons stipulated in current legislation.
By signing the attached consent form, you agree to comply with the study procedures explained to you. When your participation is over, you will receive the best available treatment that your doctor considers most appropriate for your condition.
- Conditions
- People With Chronic Low Back Pain
- Being tested
- Control group, Experimental group
- Keywords
- Chronic Low Back Pain, Exercise Therapy, Resistance Training, Self-selected exercise, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupBehavioural
The control group will carry out a physiotherapist-prescribed RT programme. Participants in this group will not be able to choose their exercises and will perform six exercises: push-ups, row, squat, deadlift, abdominal crunch and back extension.
Experimental groupBehavioural
The experimental group will follow a programme with different RT options. This proposal will be displayed on a board with detailed images of the exercises in the treatment centre. Each patient will individually choose six exercises daily; two for each body part (upper limb; lower limb; trunk). Each patient's individual choice of exercises will be recorded using checklists. Under no circumstances will the physiotherapist guidance take precedence; the clinician will refrain from expressing their preferences and beliefs regarding the selected-exercise. The patient will have the option to repeat or vary the exercises throughout the training programme, if they so decide.
For both groups, the treatment materials will include variable-resistance elastic bands, adjustable dumbbells, chairs, and a roman chair. Therapeutic supervision will be provided face-to-face for all study participants by three experimented physiotherapists from the research group.
| Study group | Role | What they receive |
|---|---|---|
| Arm experimental | Experimental | Not described Receives: Behavioral: Experimental group |
| Arm control | Active comparator | Not described Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-related distribution and intensity
Pain distribution will be evaluated using a 45-region body map to identify painful body areas. Pain intensity will be measured separately for low back pain and leg pain using the Numerical Pain Rating Scale (NPRS), a continuous measure ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
Measured: From enrollment to the end of treatment at 12 weeks
Disability
Disability will be measured as a discrete quantitative variable using the Oswestry Disability Index (ODI), with a total score ranging from 0 to 50 points, reflecting the degree of functional limitation associated with CLBP.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (6)
Treatment satisfaction
Treatment satisfaction will be evaluated as an ordinal quantitative variable using the Treatment Satisfaction Scale (CRES-4), with total scores ranging from 4 to 20 points, where higher scores indicate greater satisfaction with the received treatment.
Measured: From T1 (4 weeks) to the end of treatment at 12 weeks
Degree of compliance
Degree of compliance with treatment will be assessed as an ordinal quantitative variable based on the percentage of completed sessions out of the total 24 scheduled sessions.
Measured: From T1 (4 weeks) to the end of treatment at 12 weeks
Kinesiophobia
Kinesiophobia will be measured as a continuous quantitative variable using the Tampa Scale for Kinesiophobia (TSK-11), with scores ranging from 11 to 44 points, where higher scores reflect greater fear of movement.
Measured: From enrollment to the end of treatment at 12 weeks
Self-efficacy
Self-efficacy will be assessed as an ordinal quantitative variable using the Pain Self-Efficacy Questionnaire (PSEQ), with scores ranging from 0 to 60 points, indicating the individual's confidence in performing daily activities despite pain.
Measured: From enrollment to the end of treatment at 12 weeks
Muscle endurance
Muscle endurance will be evaluated as a continuous quantitative variable using the Biering-Sørensen test, with performance time ranging from 0 to 240 seconds.
Measured: From enrollment to the end of treatment at 12 weeks
Surface electromyographic activity of the erector spinae (longissimus) muscle (sEMG-ESL)
The activity of the erector spinae (longissimus) muscle will be assessed as a continuous quantitative variable using surface electromyography, expressed in microvolts (μV), and quantified through the root mean square (RMS) using the mDurance® device.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for People With Chronic 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
- Model description
- An 12-week, simple-blind, parallel-group, low-risk, randomized controlled trial will be conducted in people with chronic low back pain.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe
- Responsible party
- Principal investigator, Luis Gonzalez Gomez, University of Cadiz
- Investigators
- José A. Moral Muñoz, PT, PhD, Study director, University of Cadiz (Spain)Álvaro José Rodríguez Domínguez,, PT, PhD, Study director, Centro Universitario San Isidoro, affiliated with Pablo de Olavide University (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745465
- Sponsor's protocol ID
- 2026-0301-1
- Acronym
- MyBackExercise
- Status last verified
- May 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To ensure the privacy and confidentiality of participants, all clinical data collected in the study will be anonymized prior to analysis. Names, identification numbers, and specific dates will be removed, and any indirect identifiers that could allow subject identification will be grouped and coded. The anonymization process will be conducted in accordance with current ethical and regulatory standards, ensuring that the data remain valid for statistical analysis without compromising individual privacy. All physical documents will be stored in locked filing cabinets within a secure area with restricted access. Electronic data will be entered into a secure, password-protected database specifically designed for the study. Access to the data will be limited to research team members listed in the study protocol. Data supporting the findings of this study will not be publicly available due to sensitivity but may be obtained from the corresponding author upon justified request. All data will
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Self-Selected Resistance Training Program Compared With a Physiotherapist-Prescribed Resistance Training Program in People With Chronic Low Back Pain (MyBack Exercise): A Randomized Control Pilot Study
- ClinicalTrials.gov ID
- NCT07745465
- Acronym / sponsor ID
- MyBackExercise / 2026-0301-1
- Conditions
- People With Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Exercise Therapy, Resistance Training, Self-selected exercise, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Aug 2026 (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 a public health issue affecting over 20% of the Spanish population, causing disability, reduced quality of life, and work absenteeism. Over the past decades, the benefits of physical exercise for improving symptoms in patients with chronic low back pain have been studied. Exercise has also been shown to improve quality of life, general health, self-efficacy, and fear of pain, regardless of pathology. Research on the effect of physical exercise in chronic low back pain patients has shown promising results. Therefore, the therapeutic exercise program proposed in this study may help participants adopt healthy habits that positively impact their quality of life.
This will be a clinical trial in patients with chronic low back pain. The main purpose of the study is to evaluate the efficacy of a self-selected resistance training program versus physiotherapist-prescribed exercises in improving pain intensity and disability in adults with chronic low back pain. Secondary objectives include evaluating differences between the two groups after 12 weeks in treatment satisfaction, degree of compliance, kinesiophobia, self-efficacy, muscle endurance, and lumbar electromyographic activity.
If you agree to participate, a member of the research team experienced in exercise programs for chronic low back pain will instruct you on how to perform the program. The follow-up study will include 34 participants randomly assigned to two groups: one group performing self-selected resistance exercises, and one group performing physiotherapist-prescribed exercises. The study will last 12 weeks, assessing your condition at the start and end of the study. You will complete questionnaires on pain intensity (Numerical Pain Rating Scale, NPRS), disability (Oswestry Disability Index, ODI), treatment satisfaction (CRES-4), adherence to treatment, kinesiophobia (TSK-11), self-efficacy (Pain Self-Efficacy Questionnaire, PSEQ), muscle endurance (Biering-Sørensen test), and surface electromyographic activity of the erector spinae (longissimus) muscle (sEMG-ESL) using the mDurance® device.
POTENTIAL BENEFITS AND RISKS OF PARTICIPATION Expected direct benefits of participation may include improvements in pain intensity, disability, treatment satisfaction, adherence to therapeutic exercise, kinesiophobia, self-efficacy, muscle endurance, and electromyographic activity.
However, it is possible that you may not experience any personal benefit. The information obtained will contribute to scientific knowledge about CLBP and may help others in the future.
ALTERNATIVE TREATMENTS Chronic low back pain is a pathological entity with extensive study, which can present different conservative therapeutic options, such as psychological therapy, regular physical exercise and the adoption of healthy habits.
COMPENSATION Participation in this study will not incur any costs for you. OTHER RELEVANT INFORMATION Any new information discovered during your participation that may affect your willingness to participate in the study will be communicated to you by your doctor as soon as possible.
If you decide to withdraw your consent to participate in this study, no new data will be added to the database, and if samples have already been collected, you may request the destruction of all previously obtained, identifiable samples to avoid further analysis.
You should also be aware that you may be excluded from the study if the sponsor or researchers deem it necessary, either for safety reasons or because they believe you are not complying with the established procedures.
In either case, you will receive a clear explanation of the reason for your withdrawal from the study. The sponsor may suspend the study for any of the reasons stipulated in current legislation.
By signing the attached consent form, you agree to comply with the study procedures explained to you. When your participation is over, you will receive the best available treatment that your doctor considers most appropriate for your condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- An 12-week, simple-blind, parallel-group, low-risk, randomized controlled trial will be conducted in people with chronic low back pain.
| Arm | Type | Receives |
|---|---|---|
| Arm experimental | Experimental | Behavioral: Experimental group |
| Arm control | Active comparator | Behavioral: Control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants aged 18-65 years b) Low back pain, with or without referred pain to the lower limb, persisting for ≥12 weeks c) Not currently engaged in a regular structured exercise programme d) Sufficient cognitive and communication abilities to complete the assessment scales and participate in the study intervention Exclusion Criteria
- Lumbar radiculopathy or radicular pain syndrome, defined by clinical signs of nerve root involvement (e.g., dermatomal pain, neurological deficits, or positive neurodynamic tests)
- Serious spinal or non-spinal pathology explaining low back pain, identified through clinical assessment (e.g., malignancy, vertebral fracture, spinal infection, cauda equina syndrome, inflammatory spinal disease, vascular, visceral or other serious causes).
- Medical contraindications to exercise, as determined by the treating physician The presence of lumbar degenerative imaging findings (e.g., degenerative disc disease, lumbar spondylosis, facet joint osteoarthritis, or Modic changes) will not constitute an exclusion criterion, provided that the clinical presentation is consistent with chronic low back pain.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Control groupThe control group will carry out a physiotherapist-prescribed RT programme. Participants in this group will not be able to choose their exercises and will perform six exercises: push-ups, row, squat, deadlift, abdominal crunch and back extension. | Behavioural | Arm control |
| Experimental groupThe experimental group will follow a programme with different RT options. This proposal will be displayed on a board with detailed images of the exercises in the treatment centre. Each patient will individually choose six exercises daily; two for each body part (upper limb; lower limb; trunk). Each patient's individual choice of exercises will be recorded using checklists. Under no circumstances will the physiotherapist guidance take precedence; the clinician will refrain from expressing their preferences and beliefs regarding the selected-exercise. The patient will have the option to repeat or vary the exercises throughout the training programme, if they so decide. For both groups, the treatment materials will include variable-resistance elastic bands, adjustable dumbbells, chairs, and a roman chair. Therapeutic supervision will be provided face-to-face for all study participants by three experimented physiotherapists from the research group. | Behavioural | Arm experimental |
Primary outcome
Pain-related distribution and intensity
Time frame: From enrollment to the end of treatment at 12 weeks
Pain distribution will be evaluated using a 45-region body map to identify painful body areas. Pain intensity will be measured separately for low back pain and leg pain using the Numerical Pain Rating Scale (NPRS), a continuous measure ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
Disability
Time frame: From enrollment to the end of treatment at 12 weeks
Disability will be measured as a discrete quantitative variable using the Oswestry Disability Index (ODI), with a total score ranging from 0 to 50 points, reflecting the degree of functional limitation associated with CLBP.
6 secondary outcomes
Treatment satisfaction
Time frame: From T1 (4 weeks) to the end of treatment at 12 weeks
Degree of compliance
Time frame: From T1 (4 weeks) to the end of treatment at 12 weeks
Kinesiophobia
Time frame: From enrollment to the end of treatment at 12 weeks
Self-efficacy
Time frame: From enrollment to the end of treatment at 12 weeks
Muscle endurance
Time frame: From enrollment to the end of treatment at 12 weeks
Surface electromyographic activity of the erector spinae (longissimus) muscle (sEMG-ESL)
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. To ensure the privacy and confidentiality of participants, all clinical data collected in the study will be anonymized prior to analysis. Names, identification numbers, and specific dates will be removed, and any indirect identifiers that could allow subject identification will be grouped and coded. The anonymization process will be conducted in accordance with current ethical and regulatory standards, ensuring that the data remain valid for statistical analysis without compromising individual privacy. All physical documents will be stored in locked filing cabinets within a secure area with restricted access. Electronic data will be entered into a secure, password-protected database specifically designed for the study. Access to the data will be limited to research team members listed in the study protocol. Data supporting the findings of this study will not be publicly available due to sensitivity but may be obtained from the corresponding author upon justified request. All data will
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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.
José A. Moral Muñoz, PT, PhD study director
University of Cadiz (Spain)
Álvaro José Rodríguez Domínguez,, PT, PhD study director
Centro Universitario San Isidoro, affiliated with Pablo de Olavide University (Spain)
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with People With Chronic Low Back Pain, run by University of Cadiz.
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 4 inclusion and 0 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis González Gómez, PT, MSc (637958168 ext. +34, luis.gonzalezgomez@alum.uca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-related distribution and intensity (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 2 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 4 Aug 2026.