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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Electromagnetic Therapy
Transcutaneous Electrical Neurological Stimulation
Back School
Sponsored by
University Rovira i Virgili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Lleuger de Cambrils

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Electromagnetic therapy (EM)

Transcutaneous Electrical Neurological Stimulation (TENS)

Back School (BS)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 4, 2013
Last Updated
May 20, 2016
Sponsor
University Rovira i Virgili
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1. Study Identification

Unique Protocol Identification Number
NCT01899469
Brief Title
Efficiency of Physiotherapy Treatments for Low Back Pain in Women.
Acronym
LUMCRO
Official Title
Efficiency of Physiotherapy Treatments for Low Back Pain in Women.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Rovira i Virgili

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electromagnetic therapy (EM)
Arm Type
Experimental
Arm Description
The group had performed 20 sessions of EM therapy for 20 minutes and after had a 25 minutes from Back School intervention.
Arm Title
Transcutaneous Electrical Neurological Stimulation (TENS)
Arm Type
Experimental
Arm Description
The group had performed 20 sessions of TENS therapy for 20 minutes and after had a 25 minutes from Back School intervention.
Arm Title
Back School (BS)
Arm Type
Experimental
Arm Description
The group had performed 20 sessions of Back School therapy for 25 minutes.
Intervention Type
Procedure
Intervention Name(s)
Electromagnetic Therapy
Intervention Description
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
Intervention Name(s)
Transcutaneous Electrical Neurological Stimulation
Intervention Description
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
Intervention Name(s)
Back School
Intervention Description
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 Outcome Measure Information:
Title
Pain was measured at the beginning and after the treatment with the Visual Scale Analogue (VAS)
Description
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
Title
Oswestry disability index (ODI)
Description
. 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 Outcome Measure Information:
Title
Questionnaire of Physical Activity (ClassAF)
Description
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 Pre-specified Outcome Measures:
Title
Body Mass Index (BMI)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester Poblet, PT
Organizational Affiliation
University Rovira i Virgili
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Lleuger de Cambrils
City
Cambrils
State/Province
Tarragona
ZIP/Postal Code
43850
Country
Spain

12. IPD Sharing Statement

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Efficiency of Physiotherapy Treatments for Low Back Pain in Women.

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