Dorsal Scapular Nerve EntrapmentNCT06329960
Dorsal Scapular Nerve Injection Combined With Muscle Needle Release
A study testing Ultrasound-guided injection combined with needle release in people with Dorsal Scapular Nerve Entrapment, run by Peking University People's Hospital at 1 site in China.
Trial summary
Ultrasound-guided perineural injection (PIT) of 5% dextrose (D5W) hydrodissection has been widely used in the treatment of peripheral entrapment neuropathies. However, there are few studies investigating the efficacy of PIT using D5W HD for dorsal scapular nerve (DSN) entrapment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dorsal Scapular Nerve Entrapment
- What is being tested?
- Ultrasound-guided injection combined with needle release
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with DSN entrapment confirmed by electrophysiological study;
- age 18-80 years;
- patients who were irresponsive to conservative treatment;
- symptoms persisted for more than 3 months.
Who cannot join
- pregnancy
- DSN entrapment caused by trauma, surgery or occupying lesions of DSN;
- concurrent presence of rheumatic immune diseases, hypothyroidism, or diabetes mellitus;
- C5/6 lumbar radiculopathy;
- previous history of local injection or surgery for DSN entrapment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ultrasound-guided Dorsal Scapular Nerve Injection Combined With Rhomboideus Muscle Needle Release
Ultrasound-guided perineural injection (PIT) of 5% dextrose (D5W) hydrodissection has been widely used in the treatment of peripheral entrapment neuropathies. However, there are few studies investigating the efficacy of PIT using D5W HD for dorsal scapular nerve (DSN) entrapment. Generally, the DSN entrapment causes the stiffness of the major and minor rhomboideus(2). In clinical practice, the investigators observed that ultrasound-guided PIT using D5W HD combined with needle release of major and minor rhomboideus significantly relieved the pain of scapular region. Therefore, the investigators aimed to evaluate the 6-month efficacy of this procedure for the participants with DSN entrapment.
- Conditions
- Dorsal Scapular Nerve Entrapment
- Being tested
- Ultrasound-guided injection combined with needle release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided injection combined with needle releaseOther
Ultrasound-guided PIT using D5W HD for dorsal scapular nerve combined with needle release of major and minor rhomboideus
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Ultrasound-guided dorsal scapular nerve injection combined with needle release of major and minor rhomboideus Receives: Other: Ultrasound-guided injection combined with needle release |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)
VAS is the most common tool to evaluate discomfort for patients with peripheral entrapment neuropathies, with scores ranging from 0 (no pain) to 10 (intolerant pain)
Measured: before treatment, as well as 1, 3, 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion30 May 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dorsal Scapular Nerve EntrapmentStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Jiaan, Peking University People's Hospital
- Investigators
- Jiaan Zhu, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329960
- Sponsor's protocol ID
- 2024PHB019-001(3)
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lam KHS, Wu YT, Reeves KD, Galluccio F, Allam AE, Peng PWH. Ultrasound-Guided Interventions for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analyses. Diagnostics (Basel). 2023 Mar 16;13(6):1138. doi: 10.3390/diagnostics13061138.
PubMed 36980446Muir B. Dorsal scapular nerve neuropathy: a narrative review of the literature. J Can Chiropr Assoc. 2017 Aug;61(2):128-144.
PubMed 28928496
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-guided Dorsal Scapular Nerve Injection Combined With Rhomboideus Muscle Needle Release
- ClinicalTrials.gov ID
- NCT06329960
- Acronym / sponsor ID
- 2024PHB019-001(3)
- Conditions
- Dorsal Scapular Nerve Entrapment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 26 Mar 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.
Ultrasound-guided perineural injection (PIT) of 5% dextrose (D5W) hydrodissection has been widely used in the treatment of peripheral entrapment neuropathies. However, there are few studies investigating the efficacy of PIT using D5W HD for dorsal scapular nerve (DSN) entrapment. Generally, the DSN entrapment causes the stiffness of the major and minor rhomboideus(2). In clinical practice, the investigators observed that ultrasound-guided PIT using D5W HD combined with needle release of major and minor rhomboideus significantly relieved the pain of scapular region. Therefore, the investigators aimed to evaluate the 6-month efficacy of this procedure for the participants with DSN entrapment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Ultrasound-guided injection combined with needle releaseUltrasound-guided dorsal scapular nerve injection combined with needle release of major and minor rhomboideus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with DSN entrapment confirmed by electrophysiological study;
- age 18-80 years;
- patients who were irresponsive to conservative treatment;
- symptoms persisted for more than 3 months.
Key exclusion criteria (5 listed)
- pregnancy
- DSN entrapment caused by trauma, surgery or occupying lesions of DSN;
- concurrent presence of rheumatic immune diseases, hypothyroidism, or diabetes mellitus;
- C5/6 lumbar radiculopathy;
- previous history of local injection or surgery for DSN entrapment.
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 |
|---|---|---|
| Ultrasound-guided injection combined with needle releaseUltrasound-guided PIT using D5W HD for dorsal scapular nerve combined with needle release of major and minor rhomboideus | Other | Experimental group |
Primary outcome
visual analogue scale (VAS)
Time frame: before treatment, as well as 1, 3, 6 months post treatment
VAS is the most common tool to evaluate discomfort for patients with peripheral entrapment neuropathies, with scores ranging from 0 (no pain) to 10 (intolerant pain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 36980446Lam KHS, Wu YT, Reeves KD, Galluccio F, Allam AE, Peng PWH. Ultrasound-Guided Interventions for Carpal Tunnel Syndrome: A Systematic Review and Meta-Analyses. Diagnostics (Basel). 2023 Mar 16;13(6):1138. doi: 10.3390/diagnostics13061138.
- Background: PubMed 28928496Muir B. Dorsal scapular nerve neuropathy: a narrative review of the literature. J Can Chiropr Assoc. 2017 Aug;61(2):128-144.
- Individual participant dataSharing planned: Undecided
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.
Jiaan Zhu principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided injection combined with needle release in people with Dorsal Scapular Nerve Entrapment, run by Peking University People's Hospital at 1 site in China.
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 5 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 16 Apr 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 China. 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 Jiaan Zhu, PhD (+86-010-88325378, canzhujia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (VAS) (time frame: before treatment, as well as 1, 3, 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06329960, which also lists 2 linked publications.
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 Apr 2024.