Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000448549
Ethics application status
Approved
Date submitted
19/03/2015
Date registered
8/05/2015
Date last updated
18/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term effectiveness of electroanalgesia treatment in chronic low-back pain
Scientific title
Immediate effects of electroanalgesia in self-perceived pain and functionality in subjects with chronic non-specific low-back pain:a randomised controlled trial
Secondary ID [1] 286345 0
NIL
Universal Trial Number (UTN)
Trial acronym
Eletroanalgesia and low-back pain
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-perceived pain 294529 0
Lumbar degree of functionality 294530 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294838 294838 0 0
Physiotherapy
Musculoskeletal 294839 294839 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ELECTROANALGESIA PROTOCOL

The electroanalgesia treatment protocol will consist of applying transregional interferential current to the lower back region.
The stimulation parameters will be: intensity of 4000Hz, amplitude-modulated frequency of 100Hz, sweep of 50 Hz, and pulse duration of 130 micros.

The subjects will be placed in a prone position with the lower back area unclothed.

The electrotherapy treatment will be based on the interferential current and tetrapolar method; that is, with four electrodes and two intersecting channels, with a rectangular stimulus 1/1, with electrodes of 75 cm2 in area, for 25 minutes. The four self-adhesive electrodes will be symmetrically placed onto each subject's lower back region, at the level of L1 and L5, in a crossed pattern.

The treatment will undergo ten treatment sessions, applied once a day from Monday to Friday over a two weeks period of time
Intervention code [1] 291454 0
Rehabilitation
Comparator / control treatment
Subjects in the control group will undergo a classic protocol involving massage therapy, manual mobilization therapy and passive and active kinesiotherapy for the same period of time than subjects in the electrotherapy group
Control group
Active

Outcomes
Primary outcome [1] 294601 0
Lumbar self-perceived pain assessed by a Visual Analogue Scale (VAS)

A Visual Analogue Scale (VAS) will be used to measure self-reported pain. The VAS is considered to be a validated, effective, accurate, sensitive, easy to use, and reproducible method to assess acute and chronic pain.
The subject will be asked to mark in the VAS the current intensity of low back-pain. The result will be expressed in millimeters (mm), ranging from 0 to 100 mm.
Timepoint [1] 294601 0
After the two-weeks intervention protocol
Secondary outcome [1] 313700 0
Lumbar functionality assessed by means of the Oswestry Scale

The Oswestry scale is the most commonly used and recommended clinical tool to measure the functional impact of lower back pain. It is especially indicated in patients with moderate to intense disability, which are common in specialized locomotor system consultations.

This scale is a self-administered questionnaire and specific to subjects with low-back pain, which measures limitations during daily activities. It is comprised of 10 items with six possible answers. Therefore, the degree of disability is classified as minimal disability (0%-20%), moderate (20%-40%), severe (40%-60%), crippled (60%-80%) and bed bound (80%-100%)

The Oswestry scale is one of the most commonly used scales in clinical trials and has served as a reference to determine the validity of other scales.
Timepoint [1] 313700 0
After the two-weeks intervention protocol

Eligibility
Key inclusion criteria
1. Suffering from low-back pain of more than three months clinical course.

2. Not having metallic implants in the spine.

3. A global score of less than 45 on the Personal Psychological Apprehension Scale (PPAS).

4. Willingness to participate in the study as declared in
signing the informed consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A previous history of degenerative disorders of the central and/or peripheral nervous system.

2. To show any contraindication for the application of interferential electrotherapy treatment (e.g, having metallic implants, fear to electrotherapy).

3. Having surgery undertaken on the vertebral column

4. Any manual or physical treatment in the spine in the eight weeks before data collection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Presealed, numbered and opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence was obtained using the free software Epidat 3.1 (Conselleria de Sanidade, Xunta de Galicia, España y Organización Panamericana de la Salud). A research assistant not involved in the study safeguarded the sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/05/2015
Actual
18/05/2015
Date of last participant enrolment
Anticipated
22/05/2015
Actual
8/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
64
Recruitment outside Australia
Country [1] 6765 0
Spain
State/province [1] 6765 0
Sevilla

Funding & Sponsors
Funding source category [1] 290958 0
University
Name [1] 290958 0
University of Sevilla
Country [1] 290958 0
Spain
Primary sponsor type
University
Name
University of Sevilla
Address
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry.
C/ Avicena s/n 41009 Sevilla (Spain)
Country
Spain
Secondary sponsor category [1] 289640 0
None
Name [1] 289640 0
Address [1] 289640 0
Country [1] 289640 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292556 0
Comite Etico de Experimentacion de la Universidad de Sevilla
Ethics committee address [1] 292556 0
Paseo de las Delicias s/n
41013 Sevilla
Ethics committee country [1] 292556 0
Spain
Date submitted for ethics approval [1] 292556 0
Approval date [1] 292556 0
16/01/2010
Ethics approval number [1] 292556 0

Summary
Brief summary
We hypothesize that, after applying the electroanalgesia treatment protocol, subjects with chronic low back pain will experience an imporvement in pain perception and lumbar functionality. Although the use of electrotherapy has been put into question in several studies, we hypothesize that the effectiveness of electrotherapy is strongly related to the parameters used for treatment
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 356 356 0 0
/AnzctrAttachments/368164-Ethical Committee.pdf

Contacts
Principal investigator
Name 55714 0
Prof Julian Maya Martin
Address 55714 0
University of Sevilla.
Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podriatry
c/ Avicena s/n
41009, Sevilla
Country 55714 0
Spain
Phone 55714 0
(+34) 954 48 65 02
Fax 55714 0
(+34) 954 48 65 27
Email 55714 0
[email protected]
Contact person for public queries
Name 55715 0
A/Prof Alberto Marcos Heredia Rizo
Address 55715 0
University of Sevilla.
Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podriatry
c/ Avicena s/n
41009, Sevilla
Country 55715 0
Spain
Phone 55715 0
(+34) 954 48 65 07
Fax 55715 0
(+34) 954 48 65 27
Email 55715 0
[email protected]
Contact person for scientific queries
Name 55716 0
A/Prof Manuel Albornoz Cabello
Address 55716 0
University of Sevilla.
Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podriatry
c/ Avicena s/n
41009, Sevilla
Country 55716 0
Spain
Phone 55716 0
(+34) 954 48 65 02
Fax 55716 0
(+34) 954 48 65 27
Email 55716 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.