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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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
Musculoskeletal 294839 294839 0 0
Other muscular and skeletal disorders

Study type
Description of intervention(s) / exposure

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
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 6765 0
State/province [1] 6765 0

Funding & Sponsors
Funding source category [1] 290958 0
Name [1] 290958 0
University of Sevilla
Address [1] 290958 0
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry.
C/ Avicena s/n 41009 Sevilla (Spain)
Country [1] 290958 0
Primary sponsor type
University of Sevilla
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry.
C/ Avicena s/n 41009 Sevilla (Spain)
Secondary sponsor category [1] 289640 0
Name [1] 289640 0
Address [1] 289640 0
Country [1] 289640 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 292556 0
Approval date [1] 292556 0
Ethics approval number [1] 292556 0

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

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
Phone 55714 0
(+34) 954 48 65 02
Fax 55714 0
(+34) 954 48 65 27
Email 55714 0
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
Phone 55715 0
(+34) 954 48 65 07
Fax 55715 0
(+34) 954 48 65 27
Email 55715 0
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
Phone 55716 0
(+34) 954 48 65 02
Fax 55716 0
(+34) 954 48 65 27
Email 55716 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary