Chronic Low-back PainNCT05682287
The Effect of Radiofrequency of 448 kHz on Pain and Function
A study testing 448kHz capacitive resistive monopolar radiofrequency and Proprioceptive Neuromuscular Facilitation in people with Chronic Low-back Pain and Lumbago, run by University of Applied Health Sciences at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain, Lumbago, Low Back Pain, Recurrent
- What is being tested?
- 448kHz capacitive resistive monopolar radiofrequency and Proprioceptive Neuromuscular Facilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Mar 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years, chronic low back pain (CLBP)
Who cannot join
- spinal fractures, radiculopathies, history of spinal surgery, spinal stenosis, history of thrombosis, pacemaker, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Capacitive and Resistive Monopolar Radiofrequency of 448 kHz on Pain and Function in People Diagnosed With Lumbar Pain Syndrome
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:
Read more
- 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
- 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.
- Conditions
- Chronic Low-back Pain, Lumbago, Low Back Pain, Recurrent
- Being tested
- 448kHz capacitive resistive monopolar radiofrequency, Proprioceptive Neuromuscular Facilitation
- Keywords
- chronic low back pain, 448kHz capacitive resistive monopolar radiofrequency, randomised controlled trial, pain, disability
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
448kHz capacitive resistive monopolar radiofrequencyDevice
Capacitive resistive monopolar radiofrequency (CRM) treatment is a type of medical procedure that uses radiofrequency energy to heat the targeted tissue.
Proprioceptive Neuromuscular FacilitationOther
Also called PNF
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Proprioceptive Neuromuscular Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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, 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).
Measured: 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).
Measured: Change from baseline disability after two weeks (14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Mar 2022
- Primary completion30 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Jurak, University of Applied Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682287
- Sponsor's protocol ID
- 602-04/21-25/840
- Status last verified
- Jan 2023
- First submitted
- 24 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39572389
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Capacitive and Resistive Monopolar Radiofrequency of 448 kHz on Pain and Function in People Diagnosed With Lumbar Pain Syndrome
- ClinicalTrials.gov ID
- NCT05682287
- Acronym / sponsor ID
- 602-04/21-25/840
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Applied Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: 448kHz capacitive resistive monopolar radiofrequency, Other: Proprioceptive Neuromuscular FacilitationParticipants 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. |
| Control group | Active comparator | Other: Proprioceptive Neuromuscular FacilitationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- older than 18 years, chronic low back pain (CLBP)
Key exclusion criteria (1 listed)
- spinal fractures, radiculopathies, history of spinal surgery, spinal stenosis, history of thrombosis, pacemaker, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 448kHz capacitive resistive monopolar radiofrequencyCapacitive resistive monopolar radiofrequency (CRM) treatment is a type of medical procedure that uses radiofrequency energy to heat the targeted tissue. | Device | Experimental group |
| Proprioceptive Neuromuscular FacilitationAlso: PNFProprioceptive 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 | Control group, Experimental group |
Primary outcome
Change from baseline: Pain - Visual Analogue Scale (VAS)
Time frame: 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)
Time frame: 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).
2 secondary outcomes
Change from baseline: Disability - Quebec Back Pain Disability Scale (QBPD)
Time frame: Change from baseline disability after two weeks (14 days).
Change from baseline: Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Change from baseline disability after two weeks (14 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 39572389Jurak 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 448kHz capacitive resistive monopolar radiofrequency and Proprioceptive Neuromuscular Facilitation in people with Chronic Low-back Pain and Lumbago, run by University of Applied Health Sciences at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline: Pain - Visual Analogue Scale (VAS) (time frame: Change from baseline pain after two weeks (14 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.