NCT03827486: LUMBAREX

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

Status unknown NA Last updated 1 February 2019

What this trial tests

NA trial testing Standard of care (exercise) in Low Back Pain in 70 participants. Status unknown.

Timeline

1 February 2019

Primary endpoint
1 February 2020

1 May 2020

Quick facts

Lead sponsor	Hospital San Carlos, Madrid
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	1 February 2019
Primary completion	1 February 2020
Estimated completion	1 May 2020

Drugs / interventions tested

• Standard of care (exercise)
• Domicilary exercise program

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

Hospital San Carlos, Madrid

Who can join

Adults 18 to 65, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exercise therapy for treatment of acute non-specific low back pain.
   IJzelenberg W, Oosterhuis T, Hayden JA, Koes BW, et al · · 2023 · cited 15× · PMID 37646368 · DOI 10.1002/14651858.cd009365.pub2