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

NCT03827486 | Unknown

• 1 other identifier: LUMBAREX
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who present a new process

  Patient who present a recurrence

  3 months

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Other: Standard of care (exercise)

Domicilary exercise program

EXPERIMENTAL

Other: Domicilary exercise program

Interventions

Standard of care (exercise) OTHER

Exercise program according to the standard of care

Standard of care

Domicilary exercise program OTHER

Domicilary exercise program according to protocol (evidence based medicine)

Domicilary exercise program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)
• 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

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Standard of Care; Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Rossana Chiesa Estomba, MD

CONTACT

+34913003000; chiero16@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 1, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2020
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share