The Effect of Radiofrequency of 448 kHz on Pain and Function

Chronic Low-back Pain Clinical Trial

Official title:

The Effect of Capacitive and Resistive Monopolar Radiofrequency of 448 kHz on Pain and Function in People Diagnosed With Lumbar Pain Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05682287
• Other study ID #: 602-04/21-25/840
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: January 2023
• Source: University of Applied Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this trial is to compare the effects 448kHz capacitive resistive monopolar radiofrequency (CRM) with Proprioceptive Neuromuscular Facilitation (PNF) versus only PNF in chronic low back pain patients. The main questions it aims to answer are: 1. Is there any difference in interventions on reduction of pain. 2. Is there any difference in interventions on reduction of disability. Participants will in the experimental group will be treated with a combination of: 1. 448kHz capacitive resistive monopolar radiofrequency and, 2. PNF intervention Participants will in the control group will be treated only using 1. PNF intervention (identical to experimental group) Researchers will compare experimental and control group to see if there are differences in reduction of pain and disability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• older than 18 years, chronic low back pain (CLBP)

Exclusion Criteria:

• spinal fractures, radiculopathies, history of spinal surgery, spinal stenosis, history of thrombosis, pacemaker, pregnancy

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain
• Low Back Pain, Recurrent
• Lumbago

Intervention

Device:
• 448kHz capacitive resistive monopolar radiofrequency
Capacitive resistive monopolar radiofrequency (CRM) treatment is a type of medical procedure that uses radiofrequency energy to heat the targeted tissue.

Other:
• Proprioceptive Neuromuscular Facilitation
Proprioceptive neuromuscular facilitation (PNF) is a type of physical therapy that uses techniques such as stretching and strengthening exercises to improve muscle function and movement patterns.

Locations

Country	Name	City	State
Croatia	Polyclinic Cerebellum	Varaždin	Varaždinska

Sponsors (1)

Lead Sponsor	Collaborator
University of Applied Health Sciences

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline: Pain - Visual Analogue Scale (VAS)	Change from baseline pain, measured by 0-10 Visual Analogue Scale (VAS). VAS has a minimum score of 0 and a maximum score of 10. Higher score indicates a worse outcome (e.g., greater pain intensity).	Change from baseline pain after two weeks (14 days).
Primary	Change from baseline: Disability - ODI (Oswestry Low Back Pain Disability Questionnaire)	Change from baseline disability, measured by Oswestry Low Back Pain Disability Questionnaire. ODI has a minimum score of 0% and maximum score of 100%. Higher score indicates a worse outcome (e.g., greater disability).	Change from baseline disability after two weeks (14 days).
Secondary	Change from baseline: Disability - Quebec Back Pain Disability Scale (QBPD)	Change from baseline disability, measured by Quebec Back Pain Disability Scale. QBPD has a minimum score of 20 and maximum score of 100. Higher score indicates a worse outcome (e.g., greater disability).	Change from baseline disability after two weeks (14 days).
Secondary	Change from baseline: Roland-Morris Disability Questionnaire (RMDQ)	Change from baseline disability, measured by Roland-Morris Disability Questionnaire. RMDQ has a minimum score of 0 and maximum score of 24. Higher score indicates a worse outcome (e.g., greater pain-related disability).	Change from baseline disability after two weeks (14 days).