Efficiency of Physiotherapy Treatments for Low Back Pain in Women.

NCT ID: NCT01899469

Last Updated: 2016-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-08-31

Brief Summary

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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

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Electromagnetic therapy (EM)

The group had performed 20 sessions of EM therapy for 20 minutes and after had a 25 minutes from Back School intervention.

Group Type EXPERIMENTAL

Electromagnetic Therapy

Intervention Type PROCEDURE

20 sessions from Monday to Friday of 20 minutes of Electromagnetic Therapy, using the next parameters: 10 Hz of frequency and 60% of intensity, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.

Back School

Intervention Type PROCEDURE

25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.

Transcutaneous Electrical Neurological Stimulation (TENS)

The group had performed 20 sessions of TENS therapy for 20 minutes and after had a 25 minutes from Back School intervention.

Group Type EXPERIMENTAL

Transcutaneous Electrical Neurological Stimulation

Intervention Type PROCEDURE

Procedure/Surgery: Transcutaneous Electrical Neurological Stimulation (TENS)

20 sessions from Monday to Friday of 20 minutes of TENS Therapy using the next parameters: 100μs of impulse width, 80 Hz of impulse frequency, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.

Back School

Intervention Type PROCEDURE

25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.

Back School (BS)

The group had performed 20 sessions of Back School therapy for 25 minutes.

Group Type EXPERIMENTAL

Back School

Intervention Type PROCEDURE

25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.

Interventions

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Electromagnetic Therapy

20 sessions from Monday to Friday of 20 minutes of Electromagnetic Therapy, using the next parameters: 10 Hz of frequency and 60% of intensity, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.

Intervention Type PROCEDURE

Transcutaneous Electrical Neurological Stimulation

Procedure/Surgery: Transcutaneous Electrical Neurological Stimulation (TENS)

20 sessions from Monday to Friday of 20 minutes of TENS Therapy using the next parameters: 100μs of impulse width, 80 Hz of impulse frequency, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.

Intervention Type PROCEDURE

Back School

25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Rovira i Virgili

OTHER

Sponsor Role lead

Responsible Party

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Marta Romeu Ferran

SD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ester Poblet, PT

Role: PRINCIPAL_INVESTIGATOR

University Rovira i Virgili

Locations

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Hospital Lleuger de Cambrils

Cambrils, Tarragona, Spain

Site Status

Countries

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Spain

Other Identifiers

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LUMCRO

Identifier Type: -

Identifier Source: org_study_id

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