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Trial registered on ANZCTR


Registration number
ACTRN12619001617156
Ethics application status
Approved
Date submitted
16/09/2019
Date registered
22/11/2019
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of ultrasound guided intramuscular stimulation in subjects with non-specific chronic low back pain

.
Scientific title
The effectiveness of ultrasound guided intramuscular stimulation in subjects with non-specific chronic low back pain where the primary outcome is the pain,
Secondary ID [1] 298609 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain deep lumbar multifidus’ CSA 313633 0
Life quality 314961 0
Disability 314962 0
Kinesiophobia 314963 0
Deep lumbar multifidus’ CSA 314964 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312061 312061 0 0
Physiotherapy
Musculoskeletal 313307 313307 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a clinic randomized randomized study where the effectiveness of intramuscular stimulation of high and low frequencies is compared, with a group of control:

Experimental group 1: high frequency current
Experimental group 2: low frequency current
Control group: sham current

The hypothesis is that the low frequency group will get better results than that which receives high frequency due to the release of endorphins and motor stimulation provided by this kind of current.

The used current will be balanced asymmetrical biphasic polarized with continuous pulse train with 100ms pulse duration and 0.5ms pulse wide, where a group will receive low frequency (2Hz) and another will get high one (100Hz). The intensity will be the maximum bearable by the patient, during 30 minutes, si there is no minimum/maximum intensity range allowed. This current will be applied through crocodile clips anchored to a dry needling needle, placed in an ecoguided way in the deep lumbar multifidus in L5 and L1. By doing so, the needle placed in L5 will perform the dispersion electrode and L1, the active electrode.

In order to apply the current, the Physio Invasiva will be applied, with CE certificate. The technique will be executed by physiotherapists specifically trained for applying these treatments and they will be able to provide a qualification to prove that.

The electrostimulation will take place three times a month. Participants will receive the electrostimulation once on the first day, once on the tenth day and once on day 31; and every group will receive motor control exercises within the electrostimulation sessions, in such a way that all of them will receive a total of 10 exercise sessions. This exercises will be:

Knee to chest
Bridge
Leg slides and leg lifts
Arm lifts
Hip abduction

In addition, patients will have to do the specific exercises individually between different sessions. Finally, one month after, another intervention of electrostimulation will take place, this time without motor control exercises.

The procedure will be carried out in the academic hospital Ramón y Cajal.

Intervention code [1] 315261 0
Rehabilitation
Comparator / control treatment
In the placebo group (third treatment group) a punction in the deep lumbar multifidus will be perform in L1 and L5. The current will be applied and when the patient feels it, it will be put into its mínimum, so that no current will pass.

The puntion will provide by an expert dry needle puncture and the size of the needle will change depending on each patient between 40 or 50 mm.. This needles are specific for dry needling.
Control group
Placebo

Outcomes
Primary outcome [1] 321025 0
Number of participants who experience more than 3 in a Numerical Rating Pain Scale
Timepoint [1] 321025 0
Immediately pretreatment, immediately post treatment (10 days after first treatment), 3 months and 6 months post treatment.

Pain (primary outcome) will be assessed at baseline, 10 days after first treatment, 3 months and 6 months since the first treatment.
Secondary outcome [1] 373722 0
Disability perceived by the patient rating with the scale Roland - Morris Disability Questionnarie.
Timepoint [1] 373722 0
Immediately pretreatment, immediately post treatment (10 days after first treatment), 1 month and 6 months post treatment.
Secondary outcome [2] 373723 0
Life quality perceived by the patient rating it with the scale SF – 36.
Timepoint [2] 373723 0
Immediately pretreatment, immediately post treatment (10 days after first treatment), 1 month and 6 months post treatment.
Secondary outcome [3] 373724 0
Kinesiophobia: Fear of movement provoked by the lumbar pain evaluated with the questionnaire Tampa Scale for kinesiophobia.
Timepoint [3] 373724 0
Immediately pretreatment, immediately post treatment (10 days after first treatment), 1 month and 6 months post treatment.
Secondary outcome [4] 373725 0
Cross sectional area of deep multifidus: It will be observed wether the diameter of the muscle has increased through ultrasound imaging.
Timepoint [4] 373725 0
Immediately pretreatment, immediately post treatment (10 days after first treatment), 1 month and 6 months post treatment.

Eligibility
Key inclusion criteria
The key inclusion criteria are the following: non-specific low back pain of more than three months of development (diagnosed by the rehabilitating doctor), with a mínimum pain of 3 in the Numercial Pain Rating Scale (NPRS), without radiation to lower limbs.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
lumbar column earlier surgeries, column pathologies (fractures, tumors, rheumatology pathologies and inflammatories and infectious processes), nervous system involvement (e.g. weakness, reflex movements alteration and sensivity alteration in the same spinal level), osteoarthrosis or discal injuries, cardiopulmonary diseases, thrombosis or risk of suffering from it, pregnant women, metallic implant, susceptibility to electric stimulation, fear of needles or not Spanish speakers.

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)
It will be through sealed envelopes with a number in it. The patient will belong to one group or another depending on the number of the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised controlled trial will be performed using the Random Allocation Software ® programme.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In order to obtain the sample number needed to get statistically significant results, we resort to an earlier article: Leite, P., Mendonça, A., Maciel, L., Poderoso-Neto, M., Araujo, C., Góis, H., Souza, J. and DeSantana, J. (2018). Does Electroacupuncture Treatment Reduce Pain and Change Quantitative Sensory Testing Responses in Patients with Chronic Nonspecific Low Back Pain? A Randomized Controlled Clinical Trial. Evidence-Based Complementary and Alternative Medicine, 2018, pp.1-8.

The statistical analysis will be carried out with the SPPSS programme through an ANOVA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/12/2019
Actual
Date of last participant enrolment
Anticipated
12/05/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 21759 0
Spain
State/province [1] 21759 0
Madrid

Funding & Sponsors
Funding source category [1] 303149 0
Self funded/Unfunded
Name [1] 303149 0
Country [1] 303149 0
Primary sponsor type
Individual
Name
Luis López González
Address
Ramón y Cajal hospital, Ctra. Colmenar Viejo, km. 9, 100, 28034 Madrid.
Country
Spain
Secondary sponsor category [1] 303146 0
Individual
Name [1] 303146 0
Jorge Román - Toledo Blanco
Address [1] 303146 0
MClinic physiotherapy, Plaza del Primero de Mayo, 9, 2. 28840, Mejorada del Campo, Madrid.
Country [1] 303146 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303699 0
Academic hospital Ramón y Cajal’s ethics committee.
Ethics committee address [1] 303699 0
Ethics committee country [1] 303699 0
Spain
Date submitted for ethics approval [1] 303699 0
04/09/2019
Approval date [1] 303699 0
16/09/2019
Ethics approval number [1] 303699 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94534 0
Prof Luis López González
Address 94534 0
Ramón y Cajal hospital, Ctra. Colmenar Viejo, km. 9, 100, 28034, Madrid
Country 94534 0
Spain
Phone 94534 0
+34913368250
Fax 94534 0
Email 94534 0
luislopezgonzalez4@gmail.com
Contact person for public queries
Name 94535 0
Luis López González
Address 94535 0
Ramón y Cajal hospital, Ctra. Colmenar Viejo, km. 9, 100, 28034 Madrid.
Country 94535 0
Spain
Phone 94535 0
+34 913368250
Fax 94535 0
Email 94535 0
llopezgonzalez@salud.madrid.org
Contact person for scientific queries
Name 94536 0
Luis López González
Address 94536 0
Ramón y Cajala hospital, Ctra. Colmenar Viejo, km. 9, 100, 28034 Madrid
Country 94536 0
Spain
Phone 94536 0
+34913368250
Fax 94536 0
Email 94536 0
llopezgonzalez@salud.madrid.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We consider that it is not necessary to provide this information.


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.