Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women (ECOLUM)

University Rovira i Virgili

Status: Unknown

Conditions: Low Back Pain

Treatments: Procedure: Core Stability Exercises (CSE); Device: TENS; Device: Infra-red; Procedure: Traditional Back School

Study type: Interventional

Funder types: Other

Identifiers

NCT02103036

ECOLUM

Details and patient eligibility

About

The purpose of the study is determine whether the Core Stability Exercise is more effective than the traditional Back School for low back pain (LBP) in women.

Full description

The aim of this study is to check what kind of exercises are the best to treat LBP with regard to clinical improvements. The secondary objectives are: to determine which treatment is more effective in improving pain in the fewest sessions possible, to determine the involvement of inflammatory biomarkers in the development of pain and revalue the results after one month of having finishing treatment.

The project is a longitudinal, single-blind and randomized study with two treatment groups:

GROUP 1: Infrared light+ Transcutaneous Electrical Nerve Stimulation (TENS) + Core Stability Exercises.

GROUP 2: Infrared light + Transcutaneous Electrical Nerve Stimulation (TENS) + Traditional Back School.

Duration of treatment: 4 weeks. The participants will performe the exercises in 20 daily sessions (Monday to Friday) guided by a physiotherapist. Following treatment with the physiotherapist, the participants should perform the exercises at home for 4 weeks at a rate of three times per week.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 18 to 70 years.
• Diagnosis of back pain from a trauma.
• Untreated pain (except acetaminophen).
• Informed consent.

Exclusion criteria

• Algic process in the lumbar spine of infectious, neoplastic, metastasis, osteoporosis, inflammatory arthritis or fractures.
• Cognitive impairment of any etiology.
• Exercise intolerance for any reason.
• Patients who have completed physical therapy in the last 3 months.
• Patients who have received infiltration injections in the last 6 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Core Stability Exercises

Experimental group

Description:

Core Stability Exercises: 20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Core Stability Exercises (25-30 minutes).

Treatment:

Device: Infra-red

Device: TENS

Procedure: Core Stability Exercises (CSE)

Traditional Back School

Experimental group

Description:

Traditional Back School: 20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Traditional Back School (25-30 minutes).

Treatment:

Procedure: Traditional Back School

Device: Infra-red

Device: TENS