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Completed

NCT Number: NCT01899469

Efficiency of Physiotherapy Treatments for Low Back Pain in Women.

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Lleuger de Cambrils

Cambrils, Tarragona, 43850, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electromagnetic Therapy

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.

Transcutaneous Electrical Neurological Stimulation

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

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.

Primary outcomes

  1. Pain was measured at the beginning and after the treatment with the Visual Scale Analogue (VAS)

    Time frame: 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

  2. Oswestry disability index (ODI)

    Time frame: 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.

Secondary outcomes

  1. Questionnaire of Physical Activity (ClassAF)

    Time frame: 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.

Other outcomes

  1. Body Mass Index (BMI)

    Time frame: 4 weeks

    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).

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Registry information

Acronym: LUMCRO

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2013
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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