An interventional study of 448kHz capacitive resistive monopolar radiofrequency and Proprioceptive Neuromuscular Facilitation in Chronic Low-back Pain, Lumbago and Low Back Pain, Recurrent, sponsored by University of Applied Health Sciences. Completed at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-12.
Sponsored by University of Applied Health Sciences · Not applicable, Interventional, and Treatment
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:
Participants will in the experimental group will be treated with a combination of:
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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's enrollment of 62 is close to the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →This is the only study on the registry with University of Applied Health Sciences as lead sponsor.
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Exclusion Criteria:
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.
Device: 448kHz capacitive resistive monopolar radiofrequency · Other: Proprioceptive Neuromuscular Facilitation
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
Capacitive resistive monopolar radiofrequency (CRM) treatment is a type of medical procedure that uses radiofrequency energy to heat the targeted tissue.
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.
Also known as: PNF
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).
Time frame: 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).
Time frame: Change from baseline disability after two weeks (14 days).
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).
Time frame: 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).
Time frame: Change from baseline disability after two weeks (14 days).
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When: Upon publication. How long: Indefinitely.
Access criteria: Available to all. No criteria for accessing the data.
Ran from Mar 2022 to primary completion in Jun 2022, 3 months.
Of 1,187 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 3 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 11 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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