The Effect of Radiofrequency of 448 kHz on Pain and Function

Not Applicable

Completed

• Conditions: Chronic Low-back Pain; Lumbago; Low Back Pain, Recurrent

• Registration Number: NCT05682287
• Lead Sponsor: University of Applied Health Sciences

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-01
• Study First Submitted: 2022-12-24
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Study First Posted: 2023-01-12
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline: Pain - Visual Analogue Scale (VAS)	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).
Change from baseline: Disability - ODI (Oswestry Low Back Pain Disability Questionnaire)	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 Outcome Measures

Name	Time	Method
Change from baseline: Roland-Morris Disability Questionnaire (RMDQ)	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).
Change from baseline: Disability - Quebec Back Pain Disability Scale (QBPD)	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).

Trial Locations

Locations (1)

Polyclinic Cerebellum; 🇭🇷 Varaždin, Varaždinska, Croatia