Efficiency of Physiotherapy Treatments for Low Back Pain in Women.

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: Back School; Procedure: Electromagnetic Therapy; Procedure: Transcutaneous Electrical Neurological Stimulation

• Registration Number: NCT01899469
• Lead Sponsor: University Rovira i Virgili

Brief Summary

Aim: To evaluate and compare the effectiveness of a combined treatment of TENS or Elec-tromagnetic and Back School with the effectiveness of only the Back School treatment.

Design: Single-blind experimental prospective study of clinic intervention. Setting: Physiotherapy and Speech Therapy Unit at the Cambrils Slight Hospital. Spain.

Population: 96 women (50-85 years) with chronic low back pathology. Methods: Subjects were divided into three randomized groups: Back School (group 1), TENS with Back School (group 2), and Magnetic therapy with Back School (group 3). They have re-ceived 20 sessions of treatment. The intensity of pain (EVA Scale) and the quality of life (Oswestry Scale) were measured, at the beginning and at the end of the treatment and after three and six months. Anthropometric and physical activity variables were collected.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-15
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• Women between 50 and 85 years.
• Chronic LBP condition for at least three months ago.
• Patient's agreement by signing the consent.

Exclusion Criteria

• Cardiac pacemaker carriers.
• Patients with parts of osteosynthesis and / or prostheses.
• Patients with a not well balanced medical condition.
• Patients with TENS at home and / or having completed physiotherapy during the last three months.
• Patients with skin infectious diseases or skin lesions and / or areas of hypoesthesia.
• Patients with malignant tumours.
• Patients who received any spinal injection during the last six weeks.
• Patients who participate or have participated in a study in the last three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Back School (BS)	Back School	The group had performed 20 sessions of Back School therapy for 25 minutes.
Electromagnetic therapy (EM)	Electromagnetic Therapy	The group had performed 20 sessions of EM therapy for 20 minutes and after had a 25 minutes from Back School intervention.
Transcutaneous Electrical Neurological Stimulation (TENS)	Back School	The group had performed 20 sessions of TENS therapy for 20 minutes and after had a 25 minutes from Back School intervention.
Electromagnetic therapy (EM)	Back School	The group had performed 20 sessions of EM therapy for 20 minutes and after had a 25 minutes from Back School intervention.
Transcutaneous Electrical Neurological Stimulation (TENS)	Transcutaneous Electrical Neurological Stimulation	The group had performed 20 sessions of TENS therapy for 20 minutes and after had a 25 minutes from Back School intervention.

Primary Outcome Measures

Name	Time	Method
Oswestry disability index (ODI)	24 weeks	. The ODI assesses nine different aspects of disability, affecting various functions of daily life (personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). The questionnaire is scored using a global percentage score. For every section, one of six options is chosen. Each section is scored 0-5, with 0 indicating no limitation of function due to pain, and with 5 indicating major functional disability due to back pain.
Pain was measured at the beginning and after the treatment with the Visual Scale Analogue (VAS)	24 weeks	The VAS scale represents the pain intensity on a line of 10 cm, at 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

Secondary Outcome Measures

Name	Time	Method
Questionnaire of Physical Activity (ClassAF)	4 weeks	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.

Trial Locations

Locations (1)

Hospital Lleuger de Cambrils; 🇪🇸 Cambrils, Tarragona, Spain