- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05909462
Comparison of the Effects Suprascapular Nerve Block and Intra-articular Shoulder Injection
Comparison of the Effects of Ultrasonography-guided Suprascapular Nerve Block and Intra-articular Shoulder Injection on Pain, Functional Status and Range of Motion in Patients With Adhesive Capsulitis; Randomized, Controlled Trial
Objectives: In this study, we aimed to compare the efficacy of ultrasonography-guided suprascapular nerve block and intra-articular shoulder injection treatment in terms of joint range of motion, pain and functional status in patients with adhesive capsulitis (AC).
Patients and Methods: 60 patients AC were included in our study. The patients were randomized into two groups according to the sealed envelope method. In the evaluation of the patients before the injection, age, gender, body mass index (BMI), occupation, education, duration of complaint, symptomatic side and dominant hand information were recorded. In the first group, 2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine injection were mixed with the posterior approach method into the shoulder joint under the guidance of ultrasonography (USG). The second group underwent suprascapular nerve block (SSNB) injection with 2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine under USG guidance. Shoulder range of motion (ROM), visual analog scale (VAS) scores and Shoulder Pain and Disability Index (SPADI) scores were compared before the injection, on the tenth day after the injection and at the third month after the injection.
Conclusion: As a result of our study, although it was observed that both methods provided improvement in the treatment process, the significant improvement in the SSNB group indicates that it is a more reliable treatment method in AC treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Çorum, Turkey (Türkiye), 19030
- Hitit University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
unilateral stage 2-3 AC
- no shoulder trauma in the last 3 months
- no shoulder injections
- no bleeding disorder
- no history of malignancy
- no history of inflammatory disease
Exlusion Criteria:
- malignancy
- inflammatory disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: suprascapular verve block
2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine
|
ultrasonography-guided suprascapular nerve block and intra-articular shoulder injection
Other Names:
|
|
Experimental: intraarticular shoulder injection
2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine
|
ultrasonography-guided suprascapular nerve block and intra-articular shoulder injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from baseline in pain on The Shoulder Pain and Disability Index (SPADI) at the tenth day after the injection
Time Frame: baseline and on the tenth day after the injection
|
SPADI is a valid and reliable questionnaire used in shoulder disorders.
Possible scores range from 0 (no pain) to 100 (severe shoulder pain)= Changes tenth day after the injection-baseline
|
baseline and on the tenth day after the injection
|
|
The effectiveness of suprascapular nerve block on pain is higher than intra-articular
Time Frame: between before treatment and on the tenth day after the injection
|
Shoulder Pain and Disability Index
|
between before treatment and on the tenth day after the injection
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-56
- Deniz İpek (Other Identifier: Hitit University)
- Mehmet Yalvaç (Other Identifier: Hitit University)
- Murat Doğan (Other Identifier: Hitit University)
- Abdulrahim Dündar (Other Identifier: Hitit University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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