Chronic PainNCT03888963
Pulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast
A study testing PRF in people with Chronic Pain, run by Assiut University at 1 site in Egypt.
Trial summary
The investigators will evaluate the analgesic efficacy of pulsed radiofrequency on the thoracic paravertebral nerves for patients with chronic mastalgia of fibrocystic disease of the breast Read more about this study
- Who is it for?
- Ages 16 to 60 years, women only
- Conditions the study is for
- Chronic Pain
- What is being tested?
- PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2019to 20 Sep 2019
- 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 16 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with chronic mastalgia due to fibrocystic disease of the breast
- the pain duration maintained for more than 1 year
- the pain intensity is more than 5 on VAS pain score
Who cannot join
- coagulopathy
- infection at the site of the procedure
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Diab
Asyut, 71111
nuha awad, hetta@aun.edu.eg
About this study
Official title: for Patients With Fibrocystic Disease of the Breast, Does Pulsed Radiofrequency on Thoracic Paravertebral Nerve Reduce Pain Severity
The investigators will evaluate the analgesic efficacy of pulsed radiofrequency on the thoracic paravertebral nerves for patients with chronic mastalgia of fibrocystic disease of the breast
- Conditions
- Chronic Pain
- Being tested
- PRF, SHAM
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFProcedure or surgery
patients will receive pulsed radiofrequency, 4 cycles (each cycle, 2 minutes) on the thoracic paravertebral nerves number 2,3, and 4 under fluroscopic guidance
SHAMProcedure or surgery
patients will be subjected to the same procedure like PRF group without giving PRF
| Study group | Role | What they receive |
|---|---|---|
| PRF | Experimental | Not described Receives: Procedure: PRF |
| SHAM | Sham comparator | Not described Receives: Procedure: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes in pain intensity measured by VAS pain score
VAS pain score, is a scale for pain measurements scored from 0 to 10 in which 0 = no pain and 10 = the worst imaginable pain
Measured: patients will be evaluated at 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start28 Mar 2019
- Primary completion20 Aug 2019 (estimated)
- Study completion20 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diab Fuad Hetta, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888963
- Sponsor's protocol ID
- SECI-IRB-IORG0009563-726
- Status last verified
- Jul 2019
- First submitted
- 22 Mar 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- for Patients With Fibrocystic Disease of the Breast, Does Pulsed Radiofrequency on Thoracic Paravertebral Nerve Reduce Pain Severity
- ClinicalTrials.gov ID
- NCT03888963
- Acronym / sponsor ID
- SECI-IRB-IORG0009563-726
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 20 Aug 2019 (estimated)
- Study completion
- 20 Sep 2019 (estimated)
- First posted
- 25 Mar 2019 (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 investigators will evaluate the analgesic efficacy of pulsed radiofrequency on the thoracic paravertebral nerves for patients with chronic mastalgia of fibrocystic disease of the breast
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF | Experimental | Procedure: PRF |
| SHAM | Sham comparator | Procedure: SHAM |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- patients with chronic mastalgia due to fibrocystic disease of the breast
- the pain duration maintained for more than 1 year
- the pain intensity is more than 5 on VAS pain score
Key exclusion criteria (2 listed)
- coagulopathy
- infection at the site of the procedure
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 |
|---|---|---|
| PRFpatients will receive pulsed radiofrequency, 4 cycles (each cycle, 2 minutes) on the thoracic paravertebral nerves number 2,3, and 4 under fluroscopic guidance | Procedure or surgery | PRF |
| SHAMpatients will be subjected to the same procedure like PRF group without giving PRF | Procedure or surgery | SHAM |
Primary outcome
the changes in pain intensity measured by VAS pain score
Time frame: patients will be evaluated at 3 months postoperatively
VAS pain score, is a scale for pain measurements scored from 0 to 10 in which 0 = no pain and 10 = the worst imaginable pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF in people with Chronic Pain, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Jul 2019. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact diab hetta, MD (+201091090009, diabhetta25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes in pain intensity measured by VAS pain score (time frame: patients will be evaluated at 3 months postoperatively). 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 8 Jul 2019.