Radiofrequency Intervention in Post-COVID-19 Patients With Musculoskeletal Sequelae

NCT07074184 | Completed

• 1 other identifier: ART-GLB-RF-MUSC-COVID
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The sequelae that occur in post-COVID-19 patients are multiple and, at a therapeutic level, these represent a new challenge within the general context of the pandemic that the world is suffering. The virus has managed to end thousands of lives today and many other cases are being charged as directly responsible for a multiplicity of multisystem damages that need to be diagnosed and treated. Among the most relevant, are those that can affect to levels musculoskeletal in patients without previous pathologies, and in patients at risk who already had a pathology prior to infection. On the other hand, signs and symptoms have been observed characteristic in the organ systems described above in post-contagion patients, directly associated with sequelae SARV-CoV2. The radiofrequency (RF) of electromagnetic waves represents a technology of proven efficacy and safety in multiple fields of both human and veterinary medicine. These include neurological and pneumological pathologies, and very especially those that affect the locomotor system. In therapeutics there are different RF modalities depending on the modality, polarity, type of signal and frequency, which in turn translate into different therapeutic profiles, clinical indications, efficacy and safety. Among the RF technologies most used today and that have a greater scientific background, is the one known as Resistive Capacitive Monopolar Radio Frequency at 448 kHz (INDIBA®). This study aims to assess the efficacy and safety of RFMCR in the treatment of musculoskeletal sequelae in patients presenting this type of pathologies that appear after contagion by COVID-19. Through this non-invasive technique, the investigators want to show that RF can help the physical rehabilitation of these patients through metabolic stimulation, increased vascularization and oxygenation of directly affected tissues, effects of deep hyperthermia generated by the interaction of the current with the treated biological substrate, as well as the activation of tissue regeneration, the result of subthermal action. It is thus intended to improve signs such as global muscle capacity, which is essential for the recovery of the post-COVID-19 patients. The hypothesis of this study is that current post-COVID-19 treatments can be significantly improved in order to prevent complications and ensure the patients' well-being.

Conditions

Covid19; Musculoskeletal Injury

Keywords

COVID-19

Outcome Measures

Primary Outcomes (2)

• Joint range of motion was measured

  Measurements were taken using a goniometer of at least two joint movement axes in each casMeasurements were taken using a goniometer of at least two joint movement axes in each case

  3 months

• A muscle assessment was performed.

  Strength measurements were taken using a dynamometer. The peak torque during a 5-second concentric contraction was measured. This contraction was repeated a total of three times, with the average of the three measurements taken as the final result.

  3 months

Secondary Outcomes (4)

• Upper Limb Functional Index questionnaire

  3 months

• Lower Extremity Functional Scale for the lower limb.

  3 months

• Visual Analogue Scale for pain (VAS)

  3 months

• Patient independence (Katz Index)

  3 months

Other Outcomes (1)

• Relevant data such as the duration of each patient's symptoms

  3 months

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Placebo Group: Patient receiving treatment with radiofrequency turned off

Other: Turn off radiofrequency 448khz

Treatment group

EXPERIMENTAL

Experimental Mixed Group: Patient receiving treatment with manual therapy and radiofrequency;

Other: Radiofrequency 448khz with manual therapy

Conventional group

ACTIVE COMPARATOR

Convencional Manual Group: Patient receiving treatment with manual therapy

Other: Manual therapy

Interventions

Radiofrequency 448khz with manual therapy OTHER

The intervention in consisted of a total of 12 sessions (twice a week) of treatment. The set duration for each session was 45 minutes, except for those sessions where variable measurements were required, which lasted 60 minutes. Radiofrequency 448 Hz was administered to the affected area in two phases, depending on the electrode applied: 5 minutes of capacitive electrode and 25 minutes of resistive electrode. In addition, a specific joint physical therapy manual therapy treatment was also performed, in which pumping techniques were performed after the radiofrequency treatment.

Treatment group

Turn off radiofrequency 448khz OTHER

Radiofrequency 448 Hz was administered to the affected area in two phases, depending on the electrode applied: 10 minutes of capacitive electrode and 35 minutes of resistive electrode, both with the machine turned off.

Placebo group

Manual therapy OTHER

Articulatory pumping techniques were applied towards the painful position with the aim of reducing it.

Conventional group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between the ages of 18 and 60.
• Patients with a positive diagnosis of COVID-19.
• Patients with post-COVID-19 sequelae with elbow musculoskeletal diseases.
• Patients who signed the informed consent.

You may not qualify if:

• Patients aged before 18 years and after 60 years.
• Healthy people with no history of elbow musculoskeletal diseases
• Patients with secondary diseases that could directly affect the systems to be evaluated who were not diagnosed positive for COVID-19.

Sponsors & Collaborators

• Clinica Gema Leon: lead

Study Sites (1)

Gema León Physiotherapy and Rehabilitation Clinic

Córdoba, Andalusia, 14011, Spain

Location

Related Publications (8)

• Bito T, Tashiro Y, Suzuki Y, Kajiwara Y, Zeidan H, Kawagoe M, Sonoda T, Nakayama Y, Yokota Y, Shimoura K, Tatsumi M, Nakai K, Nishida Y, Yoshimi S, Tsuboyama T, Aoyama T. Acute effects of capacitive and resistive electric transfer (CRet) on the Achilles tendon. Electromagn Biol Med. 2019;38(1):48-54. doi: 10.1080/15368378.2019.1567525. Epub 2019 Jan 19.

  PMID: 30663425 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

• Arena M. Radiofrequency A 448 kHz in the treatment of muscle spasticity in a dog with C2-C3 spinal cord injury. 2018. 12-3.

  BACKGROUND

• Erdine S, Ozyalcin NS, Cimen A, Celik M, Talu GK, Disci R. Comparison of pulsed radiofrequency with conventional radiofrequency in the treatment of idiopathic trigeminal neuralgia. Eur J Pain. 2007 Apr;11(3):309-13. doi: 10.1016/j.ejpain.2006.04.001. Epub 2006 Jun 9.

  PMID: 16762570 BACKGROUND

• Pérez-Cajaraville J., Aseguinolaza Pagola M., Molina Tresaco P., Arranz Duran J., Abejon Gonzalez D.. Trigeminal neuralgia: Gasser ganglion radiofrecuency. Rev. Soc. Esp. Dolor [Internet]. 2013 Apr [cited 2025 July 16] ; 20( 2 ): 89-100. Available from: http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1134-80462013000200007&lng=en. https://dx.doi.org/10.4321/S1134-80462013000200007.

  BACKGROUND

• Martínez Rubio A, Bordas JR. Treatment of asthma by capacitive electrical transfer (ECT). Rehab Fis. 1992; 3 (13): 18-9.

  BACKGROUND

• Alves A, Quispe A, Ávila A, Valdivia A, Chino J, Vera O. Brief history and pathophysiology of COVID-19. Diagnostic Guide and COVID-19 Treatment in Ter Intensive Units for Boliv [Internet]. 2020; 61 (1): 77-86.

  BACKGROUND

• Bito T, Suzuki Y, Kajiwara Y, Zeidan H, Harada K, Shimoura K, Tatsumi M, Nakai K, Nishida Y, Yoshimi S, Kawabe R, Yokota J, Yamashiro C, Tsuboyama T, Aoyama T. Effects of deep thermotherapy on chest wall mobility of healthy elderly women. Electromagn Biol Med. 2020 Apr 2;39(2):123-128. doi: 10.1080/15368378.2020.1737803. Epub 2020 Mar 4.

  PMID: 32131642 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gema Leon Bravo

  Departamento de Enfermería, Farmacología y Fisioterapia de la Universidad de Córdoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador Principal

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 20, 2025
• Study Start: June 16, 2021
• Primary Completion: June 21, 2022
• Study Completion: July 20, 2022
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)