Herniated Nucleus PulposusNCT06415331
Effectiveness of Conventional Therapy Plus Pulsed-Radiofrequency for Herniated Nucleus Pulposus
A study testing Pulsed radiofrequency and Conventional therapy in people with Herniated Nucleus Pulposus and Pain, run by Dr. Syaiful Anwar Hospital, Malang at 1 site in Indonesia.
Trial summary
The purpose of this research was to study whether the additional application of a certain medical intervention making use of radiofrequencies (pulsed-radiofrequency) would reduce pain in patients with herniated disk. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Herniated Nucleus Pulposus, Pain
- What is being tested?
- Pulsed radiofrequency and Conventional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Feb 2023to 16 Sep 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having an established diagnosis of HNP
- Complaint present for at least the pas 3 months
- Experiencing pain intensity of 4 or greater on the numeric rating scale
- Capable of giving informed consent
Who cannot join
- Pregnant patients
- Presence of infection at the site of pulsed radiofrequency
- HNP with red flags.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Effectiveness Between Conventional Therapy and Conventional Therapy Plus Pulsed-Radiofrequency in Herniated Nucleus Pulposus Patients at Dr. Saiful Anwar Hospital, Malang
The purpose of this research was to study whether the additional application of a certain medical intervention making use of radiofrequencies (pulsed-radiofrequency) would reduce pain in patients with herniated disk.
Read the detailed description
Pain is an uncomfortable sensory and emotional experience that can affect quality of life. Low back pain (LBP) is one of the most common causes of pain, with herniated nucleus pulposus (HNP) being a common etiology. Pulsed radiofrequency (PRF) is a relatively novel technique that has shown promising results in many applications, including spinal pain conditions.
This quasi-experimental study aimed to compare pain levels between patients who underwent conventional therapy (CT) alone and CT plus PRF as management in patients with HNP. Pain severity was measured in the numeric rating scale before and 1 month after treatment.
- Conditions
- Herniated Nucleus Pulposus, Pain
- Being tested
- Pulsed radiofrequency, Conventional therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed radiofrequencyProcedure or surgery
Individualized dose of pulsed radiofrequency is given for 6 minutes.
Conventional therapyOther
Conventional therapy for HNP consisting of:
- Acetaminophen
- NSAID: Etoricoxib, celecoxib, meloxicam, diclofenac, ibuprofen
- Muscle relaxant: eperisone, diazepam
- Opioid: codein, tramadol
- Adjuvant analgesics: Amitriptyline, pregabalin, gabapentin
- Physiotherapy: Short wave diathermy, ultrasound diathermy, transcutaneous electrical nerve stimulation, and exercise
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Active comparator | Subjects in this arm received interventions which were conventional, including opioid and non-opioid analgesics, adjuvant analgesics, muscle relaxants, and physiotherapy. Receives: Other: Conventional therapy |
| Conventional therapy + pulsed radiofrequency | Experimental | Subjects in this arm received pulsed radiofrequency in addition to the same conventional therapy as the other arm. Receives: Procedure: Pulsed radiofrequency; Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Pain severity measured with the numeric rating scale (NRS). The numeric rating scale measures pain on a scale of 0-10 with 0 representing "no pain" and 10 representing "the worst pain possible".
Measured: 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start2 Feb 2023
- Primary completion14 Jul 2023
- Study completion16 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated Nucleus PulposusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Syaiful Anwar Hospital, Malang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hana H Fachir, M.D., Principal investigator, Faculty of Medicine, Universitas Brawijaya, Malang, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415331
- Sponsor's protocol ID
- RSSA-00124
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effectiveness Between Conventional Therapy and Conventional Therapy Plus Pulsed-Radiofrequency in Herniated Nucleus Pulposus Patients at Dr. Saiful Anwar Hospital, Malang
- ClinicalTrials.gov ID
- NCT06415331
- Acronym / sponsor ID
- RSSA-00124
- Conditions
- Herniated Nucleus Pulposus, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Syaiful Anwar Hospital, MalangUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 16 Sep 2023 (actual)
- First posted
- 16 May 2024 (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 purpose of this research was to study whether the additional application of a certain medical intervention making use of radiofrequencies (pulsed-radiofrequency) would reduce pain in patients with herniated disk.
Detailed description
Pain is an uncomfortable sensory and emotional experience that can affect quality of life. Low back pain (LBP) is one of the most common causes of pain, with herniated nucleus pulposus (HNP) being a common etiology. Pulsed radiofrequency (PRF) is a relatively novel technique that has shown promising results in many applications, including spinal pain conditions.
This quasi-experimental study aimed to compare pain levels between patients who underwent conventional therapy (CT) alone and CT plus PRF as management in patients with HNP. Pain severity was measured in the numeric rating scale before and 1 month after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Active comparator | Other: Conventional therapySubjects in this arm received interventions which were conventional, including opioid and non-opioid analgesics, adjuvant analgesics, muscle relaxants, and physiotherapy. |
| Conventional therapy + pulsed radiofrequency | Experimental | Procedure: Pulsed radiofrequency, Other: Conventional therapySubjects in this arm received pulsed radiofrequency in addition to the same conventional therapy as the other arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having an established diagnosis of HNP
- Complaint present for at least the pas 3 months
- Experiencing pain intensity of 4 or greater on the numeric rating scale
- Capable of giving informed consent
Key exclusion criteria (3 listed)
- Pregnant patients
- Presence of infection at the site of pulsed radiofrequency
- HNP with red flags.
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 |
|---|---|---|
| Pulsed radiofrequencyIndividualized dose of pulsed radiofrequency is given for 6 minutes. | Procedure or surgery | Conventional therapy + pulsed radiofrequency |
| Conventional therapyConventional therapy for HNP consisting of: * Acetaminophen * NSAID: Etoricoxib, celecoxib, meloxicam, diclofenac, ibuprofen * Muscle relaxant: eperisone, diazepam * Opioid: codein, tramadol * Adjuvant analgesics: Amitriptyline, pregabalin, gabapentin * Physiotherapy: Short wave diathermy, ultrasound diathermy, transcutaneous electrical nerve stimulation, and exercise | Other | Conventional therapy, Conventional therapy + pulsed radiofrequency |
Primary outcome
Pain severity
Time frame: 1 month after treatment
Pain severity measured with the numeric rating scale (NRS). The numeric rating scale measures pain on a scale of 0-10 with 0 representing "no pain" and 10 representing "the worst pain possible".
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 17 May 2024.
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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.
Hana H Fachir, M.D. principal investigator
Faculty of Medicine, Universitas Brawijaya, Malang, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed radiofrequency and Conventional therapy in people with Herniated Nucleus Pulposus and Pain, run by Dr. Syaiful Anwar Hospital, Malang at 1 site in Indonesia.
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 4 inclusion and 3 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 17 May 2024. 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 Indonesia. 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?
Pain severity (time frame: 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2024.