Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement; Ultrasound Guided Injection
• Intervention / Treatment: Drug: bupivacaine and methylprednisolone; Drug: bupivacaine and methylprednisolone; Drug: bupivacaine and methylprednisolone

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: subacromial injection; ultrasound (US)-guided subacromial injection	Drug: bupivacaine and methylprednisolone; 5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area; Drug: bupivacaine and methylprednisolone; 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; Drug: bupivacaine and methylprednisolone; suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone; Other Names: suprascapular nerve block
Active Comparator: acromioclavicular joint and subacromial injection; ultrasound (US)-guided acromioclavicular joint and subacromial injection	Drug: bupivacaine and methylprednisolone; 5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area; Drug: bupivacaine and methylprednisolone; 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; Drug: bupivacaine and methylprednisolone; suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone; Other Names: suprascapular nerve block
Active Comparator: suprascapular nerve block; ultrasound (US)-guided suprascapular nerve block	Drug: bupivacaine and methylprednisolone; 5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area; Drug: bupivacaine and methylprednisolone; 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; Drug: bupivacaine and methylprednisolone; suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone; Other Names: suprascapular nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	for pain. 0: no pain at all, 10: worst pain imaginable	six month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six month
Short-Form 12 (SF-12)	The SF-12 has a physical (SF12-PCS) and mental (SF12-MCS) state assessment scale	six month

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Burcu Metin Ökmen, Assoc. Prof, University of Health Sciences, Yuksek Ihtisas Training and Research Hospital; Study Chair: Korgün M Ökmen, Assoc. Prof, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Shoulder Impingement Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Anesthetics, Local; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Bupivacaine
• Other Study ID Numbers: BYİEAH2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No