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
About this trial
This is an interventional treatment trial for Low Back Pain
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
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
NCT ID
NCT03827486
First Posted
January 31, 2019
Last Updated
January 31, 2019
Sponsor
Hospital San Carlos, Madrid
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
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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
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