Low Back PainLUMBAREXNCT03827486
EFFECTIVENESS OF A PROGRAM OF DOMICILIARY EXERCISES AGAINST HABITUAL CLINICAL PRACTICE IN THE RECURRENCE OF ACUTE LOW BACK PAIN: RANDOMIZED CLINICAL TRIAL
A study testing Domicilary exercise program in people with Low Back Pain, run by Hospital San Carlos, Madrid.
Trial summary
Introduction: Low back pain is a frequent and universally distributed symptom that affects people of any age and both sexes. Approximately 80% of the population will present it at some point in their life. Acute low back pain lasts less than 4 weeks, subacute 4 to 12 weeks and chronic more than 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Domicilary exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 1 May 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years old.
- Low back pain of non-traumatic origin.
- Signature of informed consent.
- Availability for compliance with the intervention and commitment to send the study questionnaires.
- A correct domain of the Spanish language.
Who cannot join
- Pregnant women and breastfeeding
- Any underlying pathology that contraindicates the use of the drugs (NSAIDs, paracetamol) included in this study.
- Rheumatological diseases that cause spinal involvement (e.g., spondyloarthritis)
- Low back pain with clinical or associated neurological deficit
- History of active cancer or remission less than one year
- Pathological previous image test that shows a causal relationship with the episode under study (e.g. fracture-vertebral crush, herniated disc, etc.)
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- Low back pain associated with other systemic pathologies (eg urinary infection, retroperitoneal hematomas, pancreatitis, etc.)
- Fever
- Patients with usual analgesic treatment superior to the 1st step of WHO.
- Major psychiatric pathology diagnosed not stable (pharmacological treatment not stable in the last 6 months) except depression
- Neuromuscular pathology diagnosed
- Having some of the following diseases: fibromyalgia, chronic fatigue syndrome, chronic low back pain diagnosed
Trial locations and contacts
No sites are listed yet.
About this study
Introduction: Low back pain is a frequent and universally distributed symptom that affects people of any age and both sexes. Approximately 80% of the population will present it at some point in their life. Acute low back pain lasts less than 4 weeks, subacute 4 to 12 weeks and chronic more than 12 weeks.
Hypothesis: Treatment with an exercise program combined with the usual treatment decreases the recurrence of acute low back pain, as well as improvements in pain, functionality, and quality of life of patients.
Read more
Principal Objective To evaluate the decrease of recurrence of low back pain in the medium-long term of the patients who perform an exercise program compared to those who do not, with both groups receiving the same pharmacological treatment and information of the postural hygiene guidelines endorsed by the current scientific societies.
Methods: Patients between 18 and 65 years of age who come to the emergency room with acute low back pain and who meet the eligibility criteria proposed for this study. At the first visit, patients in a control group and intervention group will be randomized. Pharmacological treatment and postural hygiene guidelines will be indicated for both groups, adding the exercise table to the intervention group. The variables chosen are the questionnaires Oswestry for functionality, Goldberg, EuroQol-5D for the quality of life, and VAS for pain; which will be measured in the first consultation, at one month, at three and at six months.
- Conditions
- Low Back Pain
- Being tested
- Standard of care (exercise), Domicilary exercise program
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care (exercise)Other
Exercise program according to the standard of care
Domicilary exercise programOther
Domicilary exercise program according to protocol (evidence based medicine)
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Not described Receives: Other: Standard of care (exercise) |
| Domicilary exercise program | Experimental | Not described Receives: Other: Domicilary exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who present a new process
Patient who present a recurrence
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Feb 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 May 2020 (estimated)
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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossana Chiesa Estomba, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827486
- Sponsor's protocol ID
- LUMBAREX
- Acronym
- LUMBAREX
- Status last verified
- Jan 2019
- First submitted
- 31 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF A PROGRAM OF DOMICILIARY EXERCISES AGAINST HABITUAL CLINICAL PRACTICE IN THE RECURRENCE OF ACUTE LOW BACK PAIN: RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT03827486
- Acronym / sponsor ID
- LUMBAREX / LUMBAREX
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 1 Feb 2019 (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.
Introduction: Low back pain is a frequent and universally distributed symptom that affects people of any age and both sexes. Approximately 80% of the population will present it at some point in their life. Acute low back pain lasts less than 4 weeks, subacute 4 to 12 weeks and chronic more than 12 weeks.
Hypothesis: Treatment with an exercise program combined with the usual treatment decreases the recurrence of acute low back pain, as well as improvements in pain, functionality, and quality of life of patients.
Principal Objective To evaluate the decrease of recurrence of low back pain in the medium-long term of the patients who perform an exercise program compared to those who do not, with both groups receiving the same pharmacological treatment and information of the postural hygiene guidelines endorsed by the current scientific societies.
Methods: Patients between 18 and 65 years of age who come to the emergency room with acute low back pain and who meet the eligibility criteria proposed for this study. At the first visit, patients in a control group and intervention group will be randomized. Pharmacological treatment and postural hygiene guidelines will be indicated for both groups, adding the exercise table to the intervention group. The variables chosen are the questionnaires Oswestry for functionality, Goldberg, EuroQol-5D for the quality of life, and VAS for pain; which will be measured in the first consultation, at one month, at three and at six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of care (exercise) |
| Domicilary exercise program | Experimental | Other: Domicilary exercise program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years old.
- Low back pain of non-traumatic origin.
- Signature of informed consent.
- Availability for compliance with the intervention and commitment to send the study questionnaires.
- A correct domain of the Spanish language.
Key exclusion criteria (12 listed)
- Pregnant women and breastfeeding
- Any underlying pathology that contraindicates the use of the drugs (NSAIDs, paracetamol) included in this study.
- Rheumatological diseases that cause spinal involvement (e.g., spondyloarthritis)
- Low back pain with clinical or associated neurological deficit
- History of active cancer or remission less than one year
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 |
|---|---|---|
| Standard of care (exercise)Exercise program according to the standard of care | Other | Standard of care |
| Domicilary exercise programDomicilary exercise program according to protocol (evidence based medicine) | Other | Domicilary exercise program |
Primary outcome
Percentage of patients who present a new process
Time frame: 3 months
Patient who present a recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Domicilary exercise program in people with Low Back Pain, run by Hospital San Carlos, Madrid.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rossana Chiesa Estomba, MD (+34913003000, chiero16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who present a new process (time frame: 3 months). 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 1 Feb 2019.