Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome
Primary Purpose
Shoulder Impingement, Ultrasound Guided Injection
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
bupivacaine and methylprednisolone
bupivacaine and methylprednisolone
bupivacaine and methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement
Eligibility Criteria
Inclusion Criteria:
- patients aged 18-65,
- who were suffering from shoulder pain for more than three months and
- who were diagnosed with IS.
- All patients included in the study were diagnosed with IS using Shoulder Magnetic Resonance imaging.
Exclusion Criteria:
- the presence of cervical radiculopathy;
- undergoing shoulder operation before;
- the presence of central nervous system or
- the presence of rheumatological disease, and polyneuropathy;
- receiving physical therapy in the shoulder area with a diagnosis of IS within the last six months; and
- receiving any injection therapy in the past.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
subacromial injection
acromioclavicular joint and subacromial injection
suprascapular nerve block
Arm Description
ultrasound (US)-guided subacromial injection
ultrasound (US)-guided acromioclavicular joint and subacromial injection
ultrasound (US)-guided suprascapular nerve block
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
for pain. 0: no pain at all, 10: worst pain imaginable
Secondary Outcome Measures
Shoulder pain and disability index (SPADI)
This scale was developed to measure pain and disability associated with shoulder pain. It consists of two parts evaluating pain and disability.
Short-Form 12 (SF-12)
The SF-12 has a physical (SF12-PCS) and mental (SF12-MCS) state assessment scale
Full Information
NCT ID
NCT05015322
First Posted
August 18, 2021
Last Updated
August 19, 2021
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05015322
Brief Title
Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome
Official Title
Comparison of the Effectiveness of the Ultrasound Guided Subacromial, Acromioclavicular With Subacromial Injection and Suprascapular Nerve Block in Patients With Shoulder Impingement Syndrome ; A Randomized Controlled, Single Blind, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Shoulder pain, which is the third most common cause of musculoskeletal pain, has different etiologies. Muscle, bone structures and connective tissue pathologies can cause shoulder pain. Impingement syndrome (IS), which can cover many terms such as rotator cuff disorders, tendinitis and tears, is one of the most common pathologies of shoulder pain.
Detailed Description
The hypothesis of this study was that injection types including ACJ would increase treatment efficacy.Therefore, this study investigated the six-month follow-up results of patients undergoing SA injection and SSNB and those receiving SA and ACJ injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement, Ultrasound Guided Injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
prospective,randomized controlled, single blind
Masking
Outcomes Assessor
Masking Description
The patients were followed up and questioned by the evaluator, who was blind to the type of injection administered to the patient.
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subacromial injection
Arm Type
Active Comparator
Arm Description
ultrasound (US)-guided subacromial injection
Arm Title
acromioclavicular joint and subacromial injection
Arm Type
Active Comparator
Arm Description
ultrasound (US)-guided acromioclavicular joint and subacromial injection
Arm Title
suprascapular nerve block
Arm Type
Active Comparator
Arm Description
ultrasound (US)-guided suprascapular nerve block
Intervention Type
Drug
Intervention Name(s)
bupivacaine and methylprednisolone
Intervention Description
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area
Intervention Type
Drug
Intervention Name(s)
bupivacaine and methylprednisolone
Intervention Description
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area for the subacromial+acromioclavicular joint injection. In addition, 2 mL of 20 mg methylprednisolone and the same concentration of local anaesthetic were injected into the acromioclavicular joint
Intervention Type
Drug
Intervention Name(s)
bupivacaine and methylprednisolone
Other Intervention Name(s)
suprascapular nerve block
Intervention Description
suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
for pain. 0: no pain at all, 10: worst pain imaginable
Time Frame
six month
Secondary Outcome Measure Information:
Title
Shoulder pain and disability index (SPADI)
Description
This scale was developed to measure pain and disability associated with shoulder pain. It consists of two parts evaluating pain and disability.
Time Frame
six month
Title
Short-Form 12 (SF-12)
Description
The SF-12 has a physical (SF12-PCS) and mental (SF12-MCS) state assessment scale
Time Frame
six month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients aged 18-65,
who were suffering from shoulder pain for more than three months and
who were diagnosed with IS.
All patients included in the study were diagnosed with IS using Shoulder Magnetic Resonance imaging.
Exclusion Criteria:
the presence of cervical radiculopathy;
undergoing shoulder operation before;
the presence of central nervous system or
the presence of rheumatological disease, and polyneuropathy;
receiving physical therapy in the shoulder area with a diagnosis of IS within the last six months; and
receiving any injection therapy in the past.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu Metin Ökmen, Assoc. Prof
Organizational Affiliation
University of Health Sciences, Yuksek Ihtisas Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Korgün M Ökmen, Assoc. Prof
Organizational Affiliation
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome
We'll reach out to this number within 24 hrs