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Low Back Pain | Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women

Low Back Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Low Back Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Core Stability Exercises (CSE)The increase in intra-abdominal pressure stiffens and strengthens the relevant structural support around the spine, compacts the arthrogenic structures and in combination with abdominal contraction, it can encourage a rigid cylinder and stiffness to occur around the spine. The relevant anatomy in these type of exercises are deep muscles like transversus abdominous, multifidus or pelvic floor. The participants will have to do 10 different exercises. They will have to perform from 8 to 10 repetitions of every exercise, guided by a physical therapist. They will be recommended about making some series more at home, three days a week, when the treatment was finished.

Procedure:Traditional Back SchoolThe back school exercises are based in the traditional activity used for improve the back pain symptoms using the breathing with the stretching of the trunk muscles, the erector spinae reinforcement, the abdominal reinforcement or the postural movements. The participants will have to do 10 different exercises. They will have to perform from 8 to 10 repetitions of every exercise, guided by a physical therapist. They will be recommended about making some series more at home, three days a week, when the treatment was finished.

Device:TENSUsed equipment: MEGASONIC 313 P4 (Carin). Application program number 15: analgesic TENS with stimulation of afferent fibers. Type of current: two-phase TNS. Width of the impulse: 70µs. Frequency of the impulse: 100Hz. Train: Not. Pause / pause activates: Not. Time of treatment: 20 minutes.

Device:Infra-redUsed equipment: INFRA - 2000 (Enraf Nonius) with the following parameters: 230 V / 50-60 Hz / 1.2 A

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Core Stability ExercisesCore 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).

Traditional Back SchoolTraditional 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).

Study Status

Unknown status

Start Date: March 2014

Completed Date: October 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Changes in Visual Scale Analogue (VAS)

Secondary Outcome: Changes in the Roland- Morris Disability Questionnaire

Study sponsors, principal investigator, and references

Principal Investigator: Rosa Nogués, Pharm.D.

Lead Sponsor: University Rovira i Virgili

Collaborator: Hospital Universitari Sant Joan de Reus

More information:https://clinicaltrials.gov/show/NCT02103036

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