The Effect of Radiofrequency of 448 kHz on Pain and Function

NCT05682287 | Completed

• 1 other identifier: 602-04/21-25/840
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is there any difference in interventions on reduction of pain.
2. 2.Is there any difference in interventions on reduction of disability.
3. 3.448kHz capacitive resistive monopolar radiofrequency and,
4. 4.PNF intervention

Conditions

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

Keywords

chronic low back pain; 448kHz capacitive resistive monopolar radiofrequency; randomised controlled trial; pain; disability

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (2)

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

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

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

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

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants in the experimental group will be treated with a combination of 448kHz capacitive resistive monopolar radiofrequency and Proprioceptive neuromuscular facilitation (PNF) over the course of two weeks. 1. 448 kHz radio frequency therapy will be carried for a duration of 15 min. Contact cream will be applied beforehand to increase the electrical conductivity in the treated area. 2. After the radiofrequency therapy, participants will exercise for exactly 20 minutes using the PNF concept exercises to mobilize the pelvis and lumbar spine, primarily strengthening the muscles of the abdomen, back and hips. Therapy will be administered for a total of 5 times in two weeks. Three times in week 1 and two times in week 2.

Device: 448kHz capacitive resistive monopolar radiofrequency; Other: Proprioceptive Neuromuscular Facilitation

Control group

ACTIVE COMPARATOR

Participants will exercise for exactly 20 minutes, over the course of two weeks, using the PNF concept exercises to mobilize the pelvis and lumbar spine, primarily strengthening the muscles of the abdomen, back and hips. Therapy will be administered for a total of 5 times in two weeks. Three times in week 1 and two times in week 2. This is identical intervention and the second intervention in the experimental group.

Other: Proprioceptive Neuromuscular Facilitation

Interventions

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.

Experimental group

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.

Also known as: PNF

Control group; Experimental group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Applied Health Sciences: lead

Study Sites (1)

Polyclinic Cerebellum

Varaždin, Varaždin County, 42000, Croatia

Location

Related Publications (1)

• Jurak I, Grabar S, Zura N, Jakus L. Evaluating the Efficacy of Capacitive Resistive Monopolar Radiofrequency Combined With Proprioceptive Neuromuscular Facilitation in Managing Chronic Low Back Pain: A Randomised Controlled Trial. Physiother Res Int. 2025 Jan;30(1):e70009. doi: 10.1002/pri.70009.

  PMID: 39572389 DERIVED

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physiotherapy

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 12, 2023
• Study Start: March 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 1, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When: Upon publication. How long: Indefinitely.
• Access Criteria: Available to all. No criteria for accessing the data.

Locations

CR (1)