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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 (LUMBAREX)

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard of care (exercise)
Domicilary exercise program
Sponsored by
Hospital San Carlos, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard of care

    Domicilary exercise program

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of patients who present a new process
    Patient who present a recurrence

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2019
    Last Updated
    January 31, 2019
    Sponsor
    Hospital San Carlos, Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03827486
    Brief Title
    EFFECTIVENESS OF A PROGRAM OF DOMICILIARY EXERCISES AGAINST HABITUAL CLINICAL PRACTICE IN THE RECURRENCE OF ACUTE LOW BACK PAIN: RANDOMIZED CLINICAL TRIAL
    Acronym
    LUMBAREX
    Official Title
    EFFECTIVENESS OF A PROGRAM OF DOMICILIARY EXERCISES AGAINST HABITUAL CLINICAL PRACTICE IN THE RECURRENCE OF ACUTE LOW BACK PAIN: RANDOMIZED CLINICAL TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2019 (Anticipated)
    Primary Completion Date
    February 1, 2020 (Anticipated)
    Study Completion Date
    May 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital San Carlos, Madrid

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of care
    Arm Type
    Active Comparator
    Arm Title
    Domicilary exercise program
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Standard of care (exercise)
    Intervention Description
    Exercise program according to the standard of care
    Intervention Type
    Other
    Intervention Name(s)
    Domicilary exercise program
    Intervention Description
    Domicilary exercise program according to protocol (evidence based medicine)
    Primary Outcome Measure Information:
    Title
    Percentage of patients who present a new process
    Description
    Patient who present a recurrence
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rossana Chiesa Estomba, MD
    Phone
    +34913003000
    Email
    chiero16@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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