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The effectiveness of ultrasound guided intramuscular stimulation in subjects with non-specific chronic low back pain .

The effectiveness of ultrasound guided intramuscular stimulation in subjects with non-specific chronic low back pain where the primary outcome is the pain,

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001617156
Enrollment
60
Registered
2019-11-22
Start date
2019-12-11
Completion date
2020-05-12
Last updated
2019-12-10

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

Conditions

None listed

Brief summary

The main aim of this study is to measure the effectiveness of intramuscular electrostimulation in non-specific chronic low back pain. Furthermore, the most suitable kind of current will be approached in terms of benefits for the patients. The hypothesis that we deal with is that low frequency will provide better results than the high one due to the release of endorphines and the motor stimulation the low frequency generates.

Interventions

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

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.

Sponsors

Luis López González
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026