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

Low Back Pain Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03827486
• Other study ID #: LUMBAREX
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: January 2019
• Source: Hospital San Carlos, Madrid
• Contact: Rossana Chiesa Estomba, MD
• Phone: +34913003000
• Email: chiero16[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Recurrence

Intervention

Other:
• Standard of care (exercise)
Exercise program according to the standard of care
• Domicilary exercise program
Domicilary exercise program according to protocol (evidence based medicine)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who present a new process	Patient who present a recurrence	3 months