Pain, ChronicPhase 2/3NCT04693312
Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference?
A Phase 2/3 study testing Depo medrol in people with Pain, Chronic, run by Assiut University at 1 site in Egypt.
Trial summary
Dorsal scapular nerve (DSN) entrapment syndrome is an under-recognized cause of neck and shoulder pain. DSN injuries can be the origin of a well-defined chronic pain syndrome, often referred to as DSN syndrome. DSN syndrome is often characterized by a dull ache along the medial border of the scapula. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Depo medrol
- 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 Jan 2020to 1 Jul 2020
- Phase
- Phase 2/3
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- scapular pain
Who cannot join
- cervical radiculopathy
Trial locations and contacts
1 site in 1 country.
About this study
Dorsal scapular nerve (DSN) entrapment syndrome is an under-recognized cause of neck and shoulder pain. DSN injuries can be the origin of a well-defined chronic pain syndrome, often referred to as DSN syndrome. DSN syndrome is often characterized by a dull ache along the medial border of the scapula.
Read the detailed description
Dorsal scapular nerve syndrome typically presents with a weakness of the levator scapulae and the rhomboid muscles, and results in a winged scapula. A winged scapula is where the scapula protrudes from the patient's back and can affect the ability to lift objects or pull and push. The winging of the scapula seen with dorsal scapular nerve syndrome is not as severe as seen as injury or paralysis of the serratus anterior muscle.
Dorsal scapular nerve entrapment is a very under-recognized cause of neck and shoulder pain. The scapular winging may be subtle, and the symptoms are easily mistaken for other problems. A careful history and physical exam, along with a high index of suspicion, are necessary for accurate diagnosis and therefore appropriate treatment. Injection of the dorsal scapular nerve under ultrasound guidance can be diagnostic as well as therapeutic.
- Conditions
- Pain, Chronic
- Being tested
- Depo medrol
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depo medrolDrug
local injection
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | scalene muscle level injection of depomedrol Receives: Drug: Depo medrol |
| Group II | Experimental | Rheumboid muscle level injection of depomedrol Receives: Drug: Depo medrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
scapular pain
visual analog scale 1-10
Measured: 3 months
Secondary outcomes (2)
movement pain
visual analog scale 1-10
Measured: 3 months
fatigue
disability fatigue score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jan 2020
- Primary completion1 Mar 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hassanien, Assiut University
- Investigators
- Manal Hassanien, MD, Principal investigator, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693312
- Sponsor's protocol ID
- Dorsal scapular entrapment
- Status last verified
- Dec 2020
- First submitted
- 13 Nov 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference?
- ClinicalTrials.gov ID
- NCT04693312
- Acronym / sponsor ID
- Dorsal scapular entrapment
- Conditions
- Pain, Chronic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 5 Jan 2021 (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.
Dorsal scapular nerve (DSN) entrapment syndrome is an under-recognized cause of neck and shoulder pain. DSN injuries can be the origin of a well-defined chronic pain syndrome, often referred to as DSN syndrome. DSN syndrome is often characterized by a dull ache along the medial border of the scapula.
Detailed description
Dorsal scapular nerve syndrome typically presents with a weakness of the levator scapulae and the rhomboid muscles, and results in a winged scapula. A winged scapula is where the scapula protrudes from the patient's back and can affect the ability to lift objects or pull and push. The winging of the scapula seen with dorsal scapular nerve syndrome is not as severe as seen as injury or paralysis of the serratus anterior muscle.
Dorsal scapular nerve entrapment is a very under-recognized cause of neck and shoulder pain. The scapular winging may be subtle, and the symptoms are easily mistaken for other problems. A careful history and physical exam, along with a high index of suspicion, are necessary for accurate diagnosis and therefore appropriate treatment. Injection of the dorsal scapular nerve under ultrasound guidance can be diagnostic as well as therapeutic.
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 |
|---|---|---|
| Group I | Experimental | Drug: Depo medrolscalene muscle level injection of depomedrol |
| Group II | Experimental | Drug: Depo medrolRheumboid muscle level injection of depomedrol |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- scapular pain
Key exclusion criteria (1 listed)
- cervical radiculopathy
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 |
|---|---|---|
| Depo medrollocal injection | Drug | Group I, Group II |
Primary outcome
scapular pain
Time frame: 3 months
visual analog scale 1-10
2 secondary outcomes
movement pain
Time frame: 3 months
fatigue
Time frame: 3 months
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 5 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Manal Hassanien, MD principal investigator
assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Depo medrol in people with Pain, Chronic, 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 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 5 Jan 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
scapular pain (time frame: 3 months). 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 5 Jan 2021.