Chronic Pain ManagementNCT06106490
Pain Managment in Chronic Shoulder Pain
A study testing the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients in people with Chronic Pain Management, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients focusing on both changes in pain and function scores Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Chronic Pain Management
- What is being tested?
- the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Nov 2024
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged from 21-60 years.
- Patients with American Society of Anesthesiologists (ASA) physical status I and II.
- Chronic shoulder pain (>3 months) and will undergo interventional treatment due to inadequate response to conservative treatments.
Who cannot join
- Refusal of procedure or participation in the study by patients.
- History of shoulder surgery, another intervention history between 3 months before and 1 year after the intervention applied.
- Patients with chronic pain syndrome due to other shoulder pathology (fibromyalgia, cervical discopathy, brachial plexus injury).
- Uncontrolled diabetes mellitus patients with glycated hemoglobin (HbA1C) levels of more than 7%.
- Patients with known history of allergy to the study drugs.
- Infection at site of injection.
- Cognitive or psychiatric illness that will lead to inability to cooperate, speak, or provide informed consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine Ain Shams University
Cairo, 11566
Amr M Abdelfatah, Professor, 01001034225, dramr2001@gmail.com
Azza M Lotfy, Lecturer, 01003574518, Azzalotfy@med.asu.edu.eg
About this study
Official title: Addition of Pulsed Radiofrequency to Suprascapular Nerve Block With Glenohumeral Steroid Injection in Patients With Chronic Shoulder Pain
The purpose of this study is to evaluate the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients focusing on both changes in pain and function scores
Read the detailed description
Shoulder pain is the second most prevalent musculoskeletal condition in adults which is frequently treated poorly and results in chronic pain .
The use of steroid injection has been demonstrated to be superior to conventional therapies, particularly non-steroidal anti-inflammatory drugs. Its impact is transient (4-6 weeks) and occasionally may not be clinically sufficient .
An alternate analgesic injection for the pain management of numerous shoulder diseases is the suprascapular nerve block (SSN) .
Although pulse radiofrequency analgesia typically lasts for a much longer period than nerve blocking, it has become increasingly popular to apply pulse radiofrequency to peripheral nerves.
- Conditions
- Chronic Pain Management
- Being tested
- the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients
- Keywords
- Shoulder pain, Suprascapular nerve block, Pulsed radiofrequency
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patientsOther
Suprascapular nerve block group: Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine
Pulsed radiofrequency group: Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine with application of pulse PRF at 42 Celsius of suprascapular nerve for 480 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Suprasacapular nerve block | Active comparator | Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine Receives: Other: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients |
| Pulsed Radiofrequency group | Active comparator | Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine with application of pulse PRF at 42 Celsius of suprascapular nerve for 480 seconds. Receives: Other: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Shoulder Pain and Disability Index (SPADI) questionnaire in both groups after the intervention
The Shoulder Pain and Disability Index (SPADI) a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities, overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction
Measured: 15th day, 1st month, 3rd month and 6th month
Secondary outcomes (3)
Numerical pain rating scale (NRS).physiological parameter
patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: 15th day, 1st month, 3rd month and 6th month
Duration of pain relief physiological parameter
when the effect of the intervention will be lost after the intervention
Measured: 15th day, 1st month, 3rd month and 6th month
Active range of motion (AROM).physiological parameter
will be measured using a geniometer.
Measured: 15th day, 1st month, 3rd month and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Nov 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain ManagementStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla yahia, Ain Shams University
- Investigators
- Amr Abdelfatah, proffessor, Study director, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106490
- Sponsor's protocol ID
- FMASU MD128/2023
- Status last verified
- Feb 2024
- First submitted
- 14 Oct 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: summary results
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Pulsed Radiofrequency to Suprascapular Nerve Block With Glenohumeral Steroid Injection in Patients With Chronic Shoulder Pain
- ClinicalTrials.gov ID
- NCT06106490
- Acronym / sponsor ID
- FMASU MD128/2023
- Conditions
- Chronic Pain Management
- Keywords
- Shoulder pain, Suprascapular nerve block, Pulsed radiofrequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 30 Oct 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 purpose of this study is to evaluate the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients focusing on both changes in pain and function scores
Detailed description
Shoulder pain is the second most prevalent musculoskeletal condition in adults which is frequently treated poorly and results in chronic pain .
The use of steroid injection has been demonstrated to be superior to conventional therapies, particularly non-steroidal anti-inflammatory drugs. Its impact is transient (4-6 weeks) and occasionally may not be clinically sufficient .
An alternate analgesic injection for the pain management of numerous shoulder diseases is the suprascapular nerve block (SSN) .
Although pulse radiofrequency analgesia typically lasts for a much longer period than nerve blocking, it has become increasingly popular to apply pulse radiofrequency to peripheral nerves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprasacapular nerve block | Active comparator | Other: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patientsPatients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine |
| Pulsed Radiofrequency group | Active comparator | Other: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patientsPatients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine with application of pulse PRF at 42 Celsius of suprascapular nerve for 480 seconds. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged from 21-60 years.
- Patients with American Society of Anesthesiologists (ASA) physical status I and II.
- Chronic shoulder pain (>3 months) and will undergo interventional treatment due to inadequate response to conservative treatments.
Key exclusion criteria (7 listed)
- Refusal of procedure or participation in the study by patients.
- History of shoulder surgery, another intervention history between 3 months before and 1 year after the intervention applied.
- Patients with chronic pain syndrome due to other shoulder pathology (fibromyalgia, cervical discopathy, brachial plexus injury).
- Uncontrolled diabetes mellitus patients with glycated hemoglobin (HbA1C) levels of more than 7%.
- Patients with known history of allergy to the study drugs.
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 |
|---|---|---|
| the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patientsSuprascapular nerve block group: Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine Pulsed radiofrequency group: Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine with application of pulse PRF at 42 Celsius of suprascapular nerve for 480 seconds. | Other | Pulsed Radiofrequency group, Suprasacapular nerve block |
Primary outcome
change of Shoulder Pain and Disability Index (SPADI) questionnaire in both groups after the intervention
Time frame: 15th day, 1st month, 3rd month and 6th month
The Shoulder Pain and Disability Index (SPADI) a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities, overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction
3 secondary outcomes
Numerical pain rating scale (NRS).physiological parameter
Time frame: 15th day, 1st month, 3rd month and 6th month
Duration of pain relief physiological parameter
Time frame: 15th day, 1st month, 3rd month and 6th month
Active range of motion (AROM).physiological parameter
Time frame: 15th day, 1st month, 3rd month and 6th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. summary results
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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.
Amr Abdelfatah, proffessor study director
Ainshams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients in people with Chronic Pain Management, run by Ain Shams 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 7 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 28 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nahla yahia, Msc (00201000312825, nahla.yahya@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Shoulder Pain and Disability Index (SPADI) questionnaire in both groups after the intervention (time frame: 15th day, 1st month, 3rd month and 6th month). 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 28 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.