The Effect of Radiofrequency of 448 kHz on Pain and Function

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: 448kHz capacitive resistive monopolar radiofrequency
* Other: Proprioceptive Neuromuscular Facilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* Capacitive resistive monopolar radiofrequency (CRM) treatment is a type of medical procedure that uses radiofrequency energy to heat the targeted tissue.<br>Other: Proprioceptive Neuromuscular Facilitation<br>* 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.<br>* Other names: PNF;|
| Active Comparator: Control group<br>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<br>* 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.<br>* Other names: PNF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 disability after two weeks (14 days). | 
| 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). | Change from baseline disability after two weeks (14 days). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic low back pain, 448kHz capacitive resistive monopolar radiofrequency, randomised controlled trial, pain, disability