Efficiency of Physiotherapy Treatments for Low Back Pain in Women. (LUMCRO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marta Romeu Ferran, University Rovira i Virgili
ClinicalTrials.gov Identifier:
NCT01899469
First received: July 4, 2013
Last updated: May 20, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention
Low Back Pain
Procedure: Electromagnetic Therapy
Procedure: Transcutaneous Electrical Neurological Stimulation
Procedure: Back School

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficiency of Physiotherapy Treatments for Low Back Pain in Women.

Resource links provided by NLM:


Further study details as provided by University Rovira i Virgili:

Primary Outcome Measures:
  • Pain was measured at the beginning and after the treatment with the Visual Scale Analogue (VAS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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

  • Oswestry disability index (ODI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    . 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.


Secondary Outcome Measures:
  • Questionnaire of Physical Activity (ClassAF) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    On the basis of BMI (kg/m2), subjects were classified as Obesity (BMI over 30), overweight (BMI between 25 and 29.9) or normal weight (BMI between 18.5 and 24.9).


Enrollment: 96
Study Start Date: March 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: 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.
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.
Experimental: 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.
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.

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.
Experimental: Back School (BS)
The group had performed 20 sessions of Back School therapy for 25 minutes.
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01899469

Locations
Spain
Hospital Lleuger de Cambrils
Cambrils, Tarragona, Spain, 43850
Sponsors and Collaborators
University Rovira i Virgili
Investigators
Principal Investigator: Ester Poblet, PT Universitat Rovira i Virgili
  More Information

Responsible Party: Marta Romeu Ferran, SD, University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT01899469     History of Changes
Other Study ID Numbers: LUMCRO 
Study First Received: July 4, 2013
Last Updated: May 20, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 21, 2016