The Effect of Radiofrequency of 448 kHz on Pain and Function

Sponsor
University of Applied Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT05682287
Collaborator
(none)
62
1
2
4
15.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 448kHz capacitive resistive monopolar radiofrequency
  • Other: Proprioceptive Neuromuscular Facilitation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Capacitive and Resistive Monopolar Radiofrequency of 448 kHz on Pain and Function in People Diagnosed With Lumbar Pain Syndrome
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

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. 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. 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
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.
Other Names:
  • PNF
  • Active Comparator: Control group

    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
    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
  • Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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

    1. 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).

    2. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Polyclinic Cerebellum Varaždin Varaždinska Croatia 42000

    Sponsors and Collaborators

    • University of Applied Health Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ivan Jurak, Head of Physiotherapy, University of Applied Health Sciences
    ClinicalTrials.gov Identifier:
    NCT05682287
    Other Study ID Numbers:
    • 602-04/21-25/840
    First Posted:
    Jan 12, 2023
    Last Update Posted:
    Jan 12, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ivan Jurak, Head of Physiotherapy, University of Applied Health Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2023