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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05909462
Other study ID # 2023-56
Secondary ID Deniz IpekMehmet
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2023
Est. completion date May 24, 2023

Study information

Verified date June 2023
Source Hitit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Sixty patients AC who applied to our Orthopedics-Traumatology and Physical Medicine-Rehabilitation Outpatient Clinic were included in our study. The study was approved by the Hitit University Clinical Research Ethics Committee (Decision number:2023-56). A well-informed written consent was obtained from all participants according to the principles of the Declaration of Helsinki. Patients with an age range of 18-65 years, adapting to the treatment program to be applied, diagnosed with unilateral stage 2-3 AC, no shoulder trauma in the last 3 months, no shoulder injections, no bleeding disorder, no history of malignancy, inflammatory disease and stroke were included in the 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. Injections were made to the patients by the physiatrist and anesthetist researcher under the guidance of Logiq V2 portable USG device. 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 USG. The second group underwent suprascapular nerve block injection with 2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine under USG guidance. In addition, pendulum and ladder-finger exercises were given to both groups as a home exercise program. 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 24, 2023
Est. primary completion date April 24, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine
ultrasonography-guided suprascapular nerve block and intra-articular shoulder injection

Locations

Country Name City State
Turkey Hitit University Çorum

Sponsors (1)

Lead Sponsor Collaborator
Hitit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline in pain on The Shoulder Pain and Disability Index (SPADI) at 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
Primary The effectiveness of suprascapular nerve block on pain is higher than intra-articular Shoulder Pain and Disability Index between before treatment and on the tenth day after the injection
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