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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

About this trial

This is an interventional treatment trial for Shoulder Impingement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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

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