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Efficacy of Therapy Using Monopolar Dielectric Radiofrequency Signals on the Symptoms of Myofascial Trigger Points in Patients With Chronic Nonspecific Low Back Pain.

NCT05471258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-10-23

No results posted yet for this study

Summary

A total of 74 people diagnosed with non-specific chronic low back pain of more than 3 months of evolution and who are not currently undergoing any type of treatment will be recruited, with ages between 35 and 65 years. A random distribution will be made into two treatment groups (monopolar diathermy by radiofrequency versus placebo). Participants will receive treatment three per week for a period of three weeks, in the physiotherapy laboratories of the University of Almería, with a follow-up evaluation post-intervention (one months) and two months after the end of treatment. At their first visit, participants will be screened for study eligibility according to the study inclusion and exclusion criteria, and will be evaluated by a therapist blinded to the intervention. After this face-to-face evaluation, patients will be randomly assigned to one of the two groups and will receive treatment for low back pain according to their random assignment group by two therapists belonging to the research group and trained in the techniques used.

Conditions

Interventions

OTHER

Experimental: monopolar dielectric diathermy

The Experimental Group formed by 30 subjects will undergo an application of monopolar electrical diathermy by radiofrequency emission (MDR) using the Physicalm® device developed by the electro-medicine company Biotronic Advance Develops SL, on the lumbar muscles by means of rotary movements and translation, adapting to the muscle fibers of the lumbar area. A pulsed emission of 840 KHz and 30v will be made dynamically during a treatment time of 20 minutes. 3 weekly sessions will be performed for 3 weeks, a total of 9 treatment sessions.

OTHER

Control: Placebo

The 30 participants in the control group will receive a placebo treatment, consisting of the same execution protocol as the EG, but with a non-emitting device whose software and hardware will be exactly the same as that used in the EG. The intervention will be simulated for 20 minutes. 3 weekly sessions will be held for 3 weeks, a total of 9 treatment sessions.

Sponsors & Collaborators

  • Universidad de Almeria

    lead OTHER

Principal Investigators

  • Adelaida María Castro Sánchez, PhD · Universidad de Almeria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2022-05-01
Completion
2022-10-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05471258 on ClinicalTrials.gov