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The Effect of Radiofrequency of 448 kHz on Pain and Function

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
448kHz capacitive resistive monopolar radiofrequency
Proprioceptive Neuromuscular Facilitation
Sponsored by
University of Applied Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring chronic low back pain, 448kHz capacitive resistive monopolar radiofrequency, randomised controlled trial, pain, disability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Polyclinic Cerebellum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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: 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).

Secondary Outcome Measures

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: 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).

Full Information

First Posted
December 24, 2022
Last Updated
January 11, 2023
Sponsor
University of Applied Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05682287
Brief Title
The Effect of Radiofrequency of 448 kHz on Pain and Function
Official Title
The Effect of Capacitive and Resistive Monopolar Radiofrequency of 448 kHz on Pain and Function in People Diagnosed With Lumbar Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Applied Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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: Is there any difference in interventions on reduction of pain. Is there any difference in interventions on reduction of disability. Participants will in the experimental group will be treated with a combination of: 448kHz capacitive resistive monopolar radiofrequency and, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Lumbago, Low Back Pain, Recurrent
Keywords
chronic low back pain, 448kHz capacitive resistive monopolar radiofrequency, randomised controlled trial, pain, disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
448kHz capacitive resistive monopolar radiofrequency
Intervention Description
Capacitive resistive monopolar radiofrequency (CRM) treatment is a type of medical procedure that uses radiofrequency energy to heat the targeted tissue.
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Facilitation
Other Intervention Name(s)
PNF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline: Pain - Visual Analogue Scale (VAS)
Description
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).
Time Frame
Change from baseline pain after two weeks (14 days).
Title
Change from baseline: Disability - ODI (Oswestry Low Back Pain Disability Questionnaire)
Description
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).
Time Frame
Change from baseline disability after two weeks (14 days).
Secondary Outcome Measure Information:
Title
Change from baseline: Disability - Quebec Back Pain Disability Scale (QBPD)
Description
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).
Time Frame
Change from baseline disability after two weeks (14 days).
Title
Change from baseline: Roland-Morris Disability Questionnaire (RMDQ)
Description
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).
Time Frame
Change from baseline disability after two weeks (14 days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Polyclinic Cerebellum
City
Varaždin
State/Province
Varaždinska
ZIP/Postal Code
42000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized IPD will be shared either as a supplement to manuscript or on adequate server for storing IPD data. Data will always be available upon inquiry by email to lead investigators. All variables that were measured will be included in the dataset.
IPD Sharing Time Frame
When: Upon publication. How long: Indefinitely.
IPD Sharing Access Criteria
Available to all. No criteria for accessing the data.

Learn more about this trial

The Effect of Radiofrequency of 448 kHz on Pain and Function

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