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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05015322
Other study ID # BYIEAH2
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2017
Est. completion date January 1, 2021

Study information

Verified date August 2021
Source Bursa Yüksek Ihtisas Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Drug:
bupivacaine and methylprednisolone
5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area
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
bupivacaine and methylprednisolone
suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) for pain. 0: no pain at all, 10: worst pain imaginable six month
Secondary 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
Secondary Short-Form 12 (SF-12) The SF-12 has a physical (SF12-PCS) and mental (SF12-MCS) state assessment scale six month
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