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

NCT05015322 | Completed Phase 4 DMC

• 1 other identifier: BYIEAH2
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Impingement; Ultrasound Guided Injection

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  for pain. 0: no pain at all, 10: worst pain imaginable

  six month

Secondary Outcomes (2)

• Shoulder pain and disability index (SPADI)

  six month

• Short-Form 12 (SF-12)

  six month

Study Arms (3)

subacromial injection

ACTIVE COMPARATOR

ultrasound (US)-guided subacromial injection

Drug: bupivacaine and methylprednisolone

acromioclavicular joint and subacromial injection

ACTIVE COMPARATOR

ultrasound (US)-guided acromioclavicular joint and subacromial injection

Drug: bupivacaine and methylprednisolone

suprascapular nerve block

ACTIVE COMPARATOR

ultrasound (US)-guided suprascapular nerve block

Drug: bupivacaine and methylprednisolone

Interventions

bupivacaine and methylprednisolone DRUG

5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area

subacromial injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Bupivacaine; Methylprednisolone

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Burcu Metin Ökmen, Assoc. Prof

  University of Health Sciences, Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Korgün M Ökmen, Assoc. Prof

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The patients were followed up and questioned by the evaluator, who was blind to the type of injection administered to the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,Assoc.Phd.M.D.

Model Details: prospective,randomized controlled, single blind

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 20, 2021
• Study Start: January 1, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08