CClinicalTrials.gg
CompletedNCT01899469LUMCROUpdated May 23, 2016

Efficiency of Physiotherapy Treatments for Low Back Pain in Women.

An interventional study of Electromagnetic Therapy and Transcutaneous Electrical Neurological Stimulation in Low Back Pain, sponsored by University Rovira i Virgili. Completed at 1 site in Spain. Open to female participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-05-23.

Sponsored by University Rovira i Virgili · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
Female
01

Study 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.

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Conditions studied

  • Low Back Pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 96 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

University Rovira i Virgili is the lead sponsor of 50 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
96 participants (actual)

Study arms

  • 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 · Procedure: Back School

  • 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: Back School

  • Experimental
    Back School (BS)

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

    Procedure: Back School

Interventions

  • ProcedureElectromagnetic 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.

  • ProcedureTranscutaneous 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.

  • ProcedureBack 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.

06

What researchers measure

Primary outcomes

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

    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

    Time frame: 24 weeks

  2. Oswestry disability index (ODI)

    . 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.

    Time frame: 24 weeks

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

Other outcomes

  1. Body Mass Index (BMI)

    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).

    Time frame: 4 weeks

07

Study locations

1 site
  • Hospital Lleuger de Cambrils
    Cambrils, Tarragona 43850, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01899469
Lead sponsor
University Rovira i Virgili
Responsible party
Marta Romeu Ferran (SD, University Rovira i Virgili) — Principal investigator
First posted
Jul 15, 2013
Start date
Mar 2012
Primary completion
Aug 2015
Completion
Aug 2015
Last update
May 23, 2016

Study contacts

Ester Poblet, PT
principal investigator · University Rovira i Virgili

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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