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

NCT05471258 | Completed DMC

• 1 other identifier: UALBIO2021/005
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Pain

Keywords

chronic low back pain; monopolar dielectric diathermy; placebo; randomised double-blind clinical trial

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Change from baseline in disability. Oswestry Low Back Pain Disability Idex.

  At baseline, at 4 weeks and at 2 months

• Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.

  At baseline, at 4 weeks and at 2 months

• Change from baseline on Quality of Life. SF-36 Health questionnaire

  At baseline, at 4 weeks and at 2 months

• Change from Mcquade Test.

  At baseline, at 4 weeks and at 2 months

• Change from baseline in lumbar mobility flexion

  At baseline, at 4 weeks and at 2 months

Study Arms (2)

Experimental: monopolar dielectric diathermy

EXPERIMENTAL

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: Experimental: monopolar dielectric diathermy

Placebo

PLACEBO COMPARATOR

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.

Other: Control: Placebo

Interventions

Experimental: monopolar dielectric diathermy OTHER

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.

Experimental: monopolar dielectric diathermy

Control: Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Adelaida María Castro Sánchez

Almería, Almeria, 04120, Spain

Location

Related Publications (11)

• 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.

  PMID: 21982256 BACKGROUND

• 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.

  PMID: 20974654 BACKGROUND

• 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.

  PMID: 16550448 BACKGROUND

• 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.

  PMID: 28919117 BACKGROUND

• 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.

  PMID: 26524223 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28139939 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 33925211 BACKGROUND

• 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.

  PMID: 32260313 BACKGROUND

• 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.

  PMID: 27745712 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adelaida María Castro Sánchez, PhD

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are not familiar with diathermy, and will lie prone while receiving treatment. They will also be cited on different days of the week to the experimental group. The therapist assessing the outcome measures does not know which group the patients belong to, and will be supervised by the principal investigator so that they do not ask any questions about it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Once the study is over, the control group will have the opportunity to receive radiofrequency treatment for three weeks.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: July 22, 2022
• Study Start: March 15, 2022
• Primary Completion: May 1, 2022
• Study Completion: October 30, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

ES (1)