Efficiency of Physiotherapy Treatments for Low Back Pain in Women.
LUMCRO
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started Mar 2012
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 4, 2013
CompletedFirst Posted
Study publicly available on registry
July 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 23, 2016
May 1, 2016
3.4 years
July 4, 2013
May 20, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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
24 weeks
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.
24 weeks
Secondary Outcomes (1)
Questionnaire of Physical Activity (ClassAF)
4 weeks
Other Outcomes (1)
Body Mass Index (BMI)
4 weeks
Study Arms (3)
Electromagnetic therapy (EM)
EXPERIMENTALThe group had performed 20 sessions of EM therapy for 20 minutes and after had a 25 minutes from Back School intervention.
Transcutaneous Electrical Neurological Stimulation (TENS)
EXPERIMENTALThe group had performed 20 sessions of TENS therapy for 20 minutes and after had a 25 minutes from Back School intervention.
Back School (BS)
EXPERIMENTALThe group had performed 20 sessions of Back School therapy for 25 minutes.
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.
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.
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 Criteria
You may qualify if:
- Women between 50 and 85 years.
- Chronic LBP condition for at least three months ago.
- Patient's agreement by signing the consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Lleuger de Cambrils
Cambrils, Tarragona, 43850, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ester Poblet, PT
University Rovira i Virgili
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- SD
Study Record Dates
First Submitted
July 4, 2013
First Posted
July 15, 2013
Study Start
March 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 23, 2016
Record last verified: 2016-05