Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference?
Primary Purpose
Pain, Chronic
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Depo medrol
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic
Eligibility Criteria
Inclusion Criteria:
- scapular pain
Exclusion Criteria:
- cervical radiculopathy
Sites / Locations
- Assiut governorate
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group I
Group II
Arm Description
scalene muscle level injection of depomedrol
Rheumboid muscle level injection of depomedrol
Outcomes
Primary Outcome Measures
scapular pain
visual analog scale 1-10
Secondary Outcome Measures
movement pain
visual analog scale 1-10
fatigue
disability fatigue score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04693312
Brief Title
Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference?
Official Title
Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
scalene muscle level injection of depomedrol
Arm Title
Group II
Arm Type
Experimental
Arm Description
Rheumboid muscle level injection of depomedrol
Intervention Type
Drug
Intervention Name(s)
Depo medrol
Intervention Description
local injection
Primary Outcome Measure Information:
Title
scapular pain
Description
visual analog scale 1-10
Time Frame
3 months
Secondary Outcome Measure Information:
Title
movement pain
Description
visual analog scale 1-10
Time Frame
3 months
Title
fatigue
Description
disability fatigue score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
scapular pain
Exclusion Criteria:
cervical radiculopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal Hassanien, MD
Organizational Affiliation
assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut governorate
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference?
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