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

NCT ID: NCT03827486

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

Group Type: ACTIVE_COMPARATOR

Standard of care (exercise)

Intervention Type: OTHER

Exercise program according to the standard of care

Domicilary exercise program

Group Type: EXPERIMENTAL

Domicilary exercise program

Intervention Type: OTHER

Domicilary exercise program according to protocol (evidence based medicine)

Interventions

Standard of care (exercise)

Exercise program according to the standard of care

Intervention Type: OTHER

Domicilary exercise program

Domicilary exercise program according to protocol (evidence based medicine)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Carlos, Madrid

OTHER

Sponsor Role: lead

Responsible Party

Rossana Chiesa Estomba

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rossana Chiesa Estomba, MD

Role: CONTACT

chiero16@gmail.com

+34913003000

Other Identifiers

LUMBAREX

Identifier Type: -

Identifier Source: org_study_id