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

Chronic Pain Clinical Trial

Official title:

Efficacy of Therapy Using Monopolar Dielectric by Radiofrequency on the Symptoms of Myofascial Trigger Points in Patients With Chronic Non-specific Low Back Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05471258
• Other study ID #: UALBIO2021/005
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: October 2023
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The technique of applying monopolar electrical diathermy by radiofrequency emission (MDR), using the Physicalm® device, allows electromagnetic waves to be applied transcutaneously in a capacitive and monopolar manner, making focused energy deposits in the areas compromised with the painful process. The intervention with this device consists of different independent programs adapted to the different modalities of clinical pain. Through adaptations of the digitally modulated electromagnetic signals in terms of their intensity, frequency, form and duration, analgesia and pain relief can be obtained in different conditions musculoskeletal.

Despite being a clinical electrotherapy technique currently widely used by physiotherapists, there are few clinical trials on the application of monopolar electrical diathermy by radiofrequency emission (MDR) in ailments of lumbar origin caused by myofascial trigger points. The difference with other systems that use high-frequency electrophysical agents such as short waves or microwaves lies mainly in the ability to penetrate the tissues, producing a thermal effect at a greater depth.

Due to all the structural and functional alterations that occur in chronic non-specific low back pain, this randomized clinical trial project was born, with the aim of providing an answer to the disabling symptoms suffered by patients with chronic non-specific low back pain, searching for tools of safe and effective treatment from the field of Physiotherapy, which report a benefit in the symptoms, functionality and quality of life of patients diagnosed with chronic non-specific low back pain caused by PGM.

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).

The 37 subjects of the experimental group (EG) will receive an application of monopolar electrical diathermy by radiofrequency emission (MDR) by means of 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 lower back, contacting and applying the treatment to the active myofascial trigger points of the following muscles: quadratus lumborum, multifidus and iliocostalis, following the PGM maps described by Travell and Simons. A pulsed emission of 840 KHz and 30v will be carried out dynamically for a treatment time of 20 minutes. 3 weekly sessions will be performed for 3 weeks, a total of 9 treatment sessions.

The 37 subjects in the control group (CG) will be administered 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.

A pulsed emission of 840 KHz and 30v will be carried out dynamically for a treatment time of 20 minutes. 3 weekly sessions will be performed for 3 weeks, a total of 9 treatment sessions.

The outcome assessor and study statistician will be blinded throughout the entire process.

A baseline assessment of the primary and secondary outcome measures will be performed before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two months after the end of the procedure intervention (follow-up).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 30, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• LBP for/over three months

• Age between 30 and 65 years

• Score equal or superior of four points on the Roland Morris Disability

• Questionnaire Not currently receiving physical therapy.

Exclusion Criteria:

• Presence of lumbar stenosis;

• Any clinical signs of radiculopathy;

• Diagnosis of spondylolisthesis;

• Diagnosis of fibromyalgia;

• Treatment with corticosteroid or oral medication within the past two weeks;

• A history of spinal surgery;

• Contraindication for MDR;

• Disease of the central or peripheral nervous system; (9) Patients with cardiac complications and / or patients who have recently undergone radiotherapy.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Adelaida María Castro Sánchez	Almería	Almeria

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Adamson J, Hunt K, Nazareth I. The influence of socio-demographic characteristics on consultation for back pain--a review of the literature. Fam Pract. 2011 Apr;28(2):163-71. doi: 10.1093/fampra/cmq085. Epub 2010 Oct 25. — View Citation

Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available. — View Citation

Albornoz-Cabello M, Barrios-Quinta CJ, Escobio-Prieto I, Sobrino-Sanchez R, Ibanez-Vera AJ, Espejo-Antunez L. Treatment of Patellofemoral Pain Syndrome with Dielectric Radiofrequency Diathermy: A Preliminary Single-Group Study with Six-Month Follow-Up. Medicina (Kaunas). 2021 Apr 28;57(5):429. doi: 10.3390/medicina57050429. — View Citation

Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6. — View Citation

GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2. Erratum In: Lancet. 2017 Oct 28;390(10106):e38. — View Citation

Ibanez-Vera AJ, Garcia-Romero JC, Alvero-Cruz JR, Lomas-Vega R. Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Apr 3;17(7):2465. doi: 10.3390/ijerph17072465. — View Citation

Kumaran B, Watson T. Radiofrequency-based treatment in therapy- related clinical practice - a narrative review. Part II: chronic conditions. Phys Ther Rev. 2016;20:325-343

Kumaran B, Watson T. Thermal build-up, decay and retention responses to local therapeutic application of 448 kHz capacitive resistive monopolar radiofrequency: A prospective randomised crossover study in healthy adults. Int J Hyperthermia. 2015;31(8):883-95. doi: 10.3109/02656736.2015.1092172. Epub 2015 Nov 2. — View Citation

Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11. — View Citation

Tashiro Y, Hasegawa S, Yokota Y, Nishiguchi S, Fukutani N, Shirooka H, Tasaka S, Matsushita T, Matsubara K, Nakayama Y, Sonoda T, Tsuboyama T, Aoyama T. Effect of Capacitive and Resistive electric transfer on haemoglobin saturation and tissue temperature. Int J Hyperthermia. 2017 Sep;33(6):696-702. doi: 10.1080/02656736.2017.1289252. Epub 2017 Feb 19. — View Citation

Úbeda A, Hernández-Bule ML, Trillo MA, Cid MA, Leal J. Cellular response tonon-thermal doses of radiofrequency currents used in electro-thermaltherapy. J Jpn Soc Laser Surg Med. 2006;27(3):187.31.

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pressure algometry (Wagner Algometer) in myofascial trigger points assessment of pressure pain threshold.	The algometer consists of a rubber tip and a dial that measures the pressure applied to the MTrP in increments of 0.5 kg. Three measurements were performed for each one of the selected trigger points: iliocostal muscle level L1; multifidus level L2, S1 and S4; quadratus lumbar PGM deep superior, deep inferior, superficial superior and superficial inferior. The average value of 3 repetitive measurements with intervals of 30 to 60 seconds was used for statistical analysis.	At baseline, at 4 weeks and at 2 months
Primary	Change from baseline in pain intensity. Visual analogue scale.	A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain	At baseline, at 4 weeks and at 2 months
Primary	Change from baseline in Roland Morris Disability Questionnaire (RMDQ).	This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.	At baseline, at 4 weeks and at 2 months
Secondary	Change from baseline in disability. Oswestry Low Back Pain Disability Idex.	It has 10 items associated to activities of daily living, each ítem has a puntuation fron 0 to 5 points.	At baseline, at 4 weeks and at 2 months
Secondary	Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.	Is a 17-item questionnaire that measures the fear of movement and (re)injury. Ratings are summed to yield a total score (ranging from 17-68 points) where higher values reflect greater fear of (re)injury.	At baseline, at 4 weeks and at 2 months
Secondary	Change from baseline on Quality of Life. SF-36 Health questionnaire	SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.	At baseline, at 4 weeks and at 2 months
Secondary	Change from Mcquade Test.	It measures the isometric endurance of trunk flexion muscles.	At baseline, at 4 weeks and at 2 months
Secondary	Change from baseline in lumbar mobility flexion	For the quantification of lumbar flexion an angular inclinometer is used (Fleximeter UM 8320-3 RJ Code Research Institute, Brazil).	At baseline, at 4 weeks and at 2 months
Secondary	Change from baseline of Pittsburgh Sleep Quality Index (PSQI)	Is a 10-item questionnaire with a total of 19 questions related to sleep habits in the previous month. The questions are divided into 7 areas, each with a score of between 0 and 3 points.	At baseline, at 4 weeks and at 2 months