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

Low Back Pain Clinical Trial

— ECOLUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02103036
• Other study ID #: ECOLUM
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2014
• Last updated: December 4, 2014
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: University Rovira i Virgili
• Contact: Rosa Nogués, Ph D.
• Phone: +34977759355
• Email: mariarosa.nogues[@]urv.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• Traditional Back School
The 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:
• TENS
Used 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.
• Infra-red
Used equipment: INFRA - 2000 (Enraf Nonius) with the following parameters: 230 V / 50-60 Hz / 1.2 A

Locations

Country	Name	City	State
Spain	Faculty of Medicine and Health Sciences	Reus	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
University Rovira i Virgili	Hospital Universitari Sant Joan de Reus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire of Physical Activity (ClassAF)	Is a method developed by the Health Department of the Catalan Government. The ClassAF is a comprehensive questionnaire which contains a few items (1-4) to measure the general level of Physical Activity, it is calculated in METS (basal metabolic expenditure: mlO2/kg.min) and it allows to classify people into physically active or physically inactive.	The physical activity will be measured at the beginning of the study (session 0).	No
Other	Changes in the biomarkers: Tumor Necrosis Factor (TNF-Alpha) and Interleukin 10 (IL-10)	These two cytokines are parameters to indicate the inflammation levels. Their concentrations are measured using commercial ELISA kits.	The concentrations of these biomarkers will be measured at the beginning (session 0) and changes will be evaluated again at the end of the treatment (session 20).	No
Primary	Changes in Visual Scale Analogue (VAS)	The VAS scale represents the pain intensity on a line of 10 cm, and one end there are the words "no pain" and the other end "the worst imaginable pain" written the distance in centimetres from the "no pain" point to the place marked by the patient represents the intensity of pain.	Pain was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.	No
Secondary	Changes in the Roland- Morris Disability Questionnaire	It consists of 24 items, which reflect limitation in different activities of daily living attributed by the patient to LBP. The patient must mark each item that applies to her current status. Scoring is also simple and fast; each checked item receives a score of 1, so scores range between 0 (no disability caused by LBP) and 24 (the maximum possible disability).	Disability was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.	No