Chronic Pain SyndromeNCT03247842
The Analgesic Efficacy Supra-scapular Nerve RF After Breast Surgery
A study testing suprascapular nerve block in people with Chronic Pain Syndrome, run by Tanta University at 1 site in Egypt.
Trial summary
Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Chronic Pain Syndrome
- What is being tested?
- suprascapular nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2017to 30 Jun 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients with post-mastectomy pain
Who cannot join
- Exclusion criteria are patients with any medical contraindications to neurolysis, patients with other bone metastases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic and Rehabilitative Value of Supra-scapular Nerve Radiofrequency in Patients With Chronic Shoulder Pain After Breast Surgery.
Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients received fluoroscopically guided supra-scapular nerve injection of of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.
Read the detailed description
Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups ; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection through the radiofrequency needle of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients received fluoroscopically guided supra-scapular nerve injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.
- Conditions
- Chronic Pain Syndrome
- Being tested
- suprascapular nerve block
- Keywords
- post mastectomy pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprascapular nerve blockProcedure or surgery
Sixty patients with shoulder dystocia after breast surgery will receive stellate ganglion neurolysis with supra-scapular nerve radiofrequency,
| Study group | Role | What they receive |
|---|---|---|
| suprascapular nerve RF | Active comparator | Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups (Figure1); forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection through the radiofrequency needle of mL of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) Receives: Procedure: suprascapular nerve block |
| suprascapular nerve block | Active comparator | and forty patients received fluoroscopically guided supra-scapular nerve injection of mL of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied. Receives: Procedure: suprascapular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
assessment using visual analogue scale
Measured: immedite postopertive
Secondary outcomes (1)
shoulder movement
shoulder mobility using long arm geniometry
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start25 Apr 2017
- Primary completion30 Sep 2017
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abd Al-maksoud Yousef, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247842
- Sponsor's protocol ID
- 3024/01/15
- Status last verified
- Jun 2020
- First submitted
- 24 Apr 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic and Rehabilitative Value of Supra-scapular Nerve Radiofrequency in Patients With Chronic Shoulder Pain After Breast Surgery.
- ClinicalTrials.gov ID
- NCT03247842
- Acronym / sponsor ID
- 3024/01/15
- Conditions
- Chronic Pain Syndrome
- Keywords
- post mastectomy pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 14 Aug 2017 (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.
Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients received fluoroscopically guided supra-scapular nerve injection of of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.
Detailed description
Eighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups ; forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection through the radiofrequency needle of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) and forty patients received fluoroscopically guided supra-scapular nerve injection of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suprascapular nerve RF | Active comparator | Procedure: suprascapular nerve blockEighty patients with chronic shoulder pain after breast surgery were allocated randomly into 2 groups (Figure1); forty patients received fluoroscopically guided supra-scapular nerve pulsed radiofrequency (PRF) followed by injection through the radiofrequency needle of mL of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group1) |
| suprascapular nerve block | Active comparator | Procedure: suprascapular nerve blockand forty patients received fluoroscopically guided supra-scapular nerve injection of mL of 0.25% bupivacaine solution containing 40 mg of methylprednisolone (group 2) without active pulsed radiofrequency only demo mode was applied. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with post-mastectomy pain
Key exclusion criteria (1 listed)
- Exclusion criteria are patients with any medical contraindications to neurolysis, patients with other bone metastases.
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 |
|---|---|---|
| suprascapular nerve blockSixty patients with shoulder dystocia after breast surgery will receive stellate ganglion neurolysis with supra-scapular nerve radiofrequency, | Procedure or surgery | suprascapular nerve RF, suprascapular nerve block |
Primary outcome
postoperative pain
Time frame: immedite postopertive
assessment using visual analogue scale
1 secondary outcome
shoulder movement
Time frame: 6 months after surgery
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 16 Jun 2020.
- 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.
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 suprascapular nerve block in people with Chronic Pain Syndrome, run by Tanta 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 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 16 Jun 2020. 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. 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?
postoperative pain (time frame: immedite postopertive). 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 16 Jun 2020.