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Efficiency of Physiotherapy Treatments for Low Back Pain in Women.

Efficiency of Physiotherapy Treatments for Low Back Pain in Women.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01899469
Acronym
LUMCRO
Enrollment
96
Registered
2013-07-15
Start date
2012-03-31
Completion date
2015-08-31
Last updated
2016-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

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.

Sponsors

University Rovira i Virgili
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 85 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pain was measured at the beginning and after the treatment with the Visual Scale Analogue (VAS)24 weeksThe 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)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

MeasureTime frameDescription
Questionnaire of Physical Activity (ClassAF)4 weeksIs 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

MeasureTime frameDescription
Body Mass Index (BMI)4 weeksOn 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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026