NCT04693312

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

November 13, 2020

Last Update Submit

December 31, 2020

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

  • scapular pain

    visual analog scale 1-10

    3 months

Secondary Outcomes (2)

  • movement pain

    3 months

  • fatigue

    3 months

Study Arms (2)

Group I

EXPERIMENTAL

scalene muscle level injection of depomedrol

Drug: Depo medrol

Group II

EXPERIMENTAL

Rheumboid muscle level injection of depomedrol

Drug: Depo medrol

Interventions

Depo medrolDRUG

local injection

Group IGroup II

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • scapular pain

You may not qualify if:

  • cervical radiculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, Egypt

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Manal Hassanien, MD

    assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 13, 2020

First Posted

January 5, 2021

Study Start

January 1, 2020

Primary Completion

March 1, 2020

Study Completion

July 1, 2020

Last Updated

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)