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EFFECTIVENESS OF A PROGRAM OF DOMICILIARY EXERCISES AGAINST HABITUAL CLINICAL PRACTICE IN THE RECURRENCE OF ACUTE LOW BACK PAIN: RANDOMIZED CLINICAL TRIAL

EFFECTIVENESS OF A PROGRAM OF DOMICILIARY EXERCISES AGAINST HABITUAL CLINICAL PRACTICE IN THE RECURRENCE OF ACUTE LOW BACK PAIN: RANDOMIZED CLINICAL TRIAL

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03827486
Acronym
LUMBAREX
Enrollment
70
Registered
2019-02-01
Start date
2019-02-01
Completion date
2020-05-01
Last updated
2019-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Brief 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. 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.

Interventions

OTHERStandard of care (exercise)

Exercise program according to the standard of care

OTHERDomicilary exercise program

Domicilary exercise program according to protocol (evidence based medicine)

Sponsors

Hospital San Carlos, Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Age between 18 and 65 years old. 2. Low back pain of non-traumatic origin. 3. Signature of informed consent. 4. Availability for compliance with the intervention and commitment to send the study questionnaires. 5. A correct domain of the Spanish language.

Exclusion criteria

1. Pregnant women and breastfeeding 2. Any underlying pathology that contraindicates the use of the drugs (NSAIDs, paracetamol) included in this study. 3. Rheumatological diseases that cause spinal involvement (e.g., spondyloarthritis) 4. Low back pain with clinical or associated neurological deficit 5. History of active cancer or remission less than one year 6. Pathological previous image test that shows a causal relationship with the episode under study (e.g. fracture-vertebral crush, herniated disc, etc.) 7. Low back pain associated with other systemic pathologies (eg urinary infection, retroperitoneal hematomas, pancreatitis, etc.) 8. Fever 9. Patients with usual analgesic treatment superior to the 1st step of WHO. 10. Major psychiatric pathology diagnosed not stable (pharmacological treatment not stable in the last 6 months) except depression 11. Neuromuscular pathology diagnosed 12. Having some of the following diseases: fibromyalgia, chronic fatigue syndrome, chronic low back pain diagnosed

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients who present a new process3 monthsPatient who present a recurrence

Contacts

Primary ContactRossana Chiesa Estomba, MD
chiero16@gmail.com+34913003000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026