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Completed

NCT Number: NCT05682287

The Effect of Radiofrequency of 448 kHz on Pain and Function

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinic Cerebellum

Varaždin, Varaždin County, 42000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

448kHz capacitive resistive monopolar radiofrequency

Device

Capacitive resistive monopolar radiofrequency (CRM) treatment is a type of medical procedure that uses radiofrequency energy to heat the targeted tissue.

Proprioceptive Neuromuscular facilitation

Other

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.

Other names: PNF

Primary outcomes

  1. Change from baseline: Pain - Visual Analogue Scale (VAS)

    Time frame: Change from baseline pain after two weeks (14 days).

    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).

  2. Change from baseline: Disability - ODI (Oswestry Low Back Pain Disability Questionnaire)

    Time frame: Change from baseline disability after two weeks (14 days).

    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).

Secondary outcomes

  1. Change from baseline: Disability - Quebec Back Pain Disability Scale (QBPD)

    Time frame: Change from baseline disability after two weeks (14 days).

    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).

  2. Change from baseline: Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: Change from baseline disability after two weeks (14 days).

    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).

Sponsors and collaborators

Lead sponsor

University of Applied Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2023
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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