Clinical trial NCT05909462: Comparison of the Effects Suprascapular Nerve Block and Intra-articular Shoulder Injection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: Adhesive capsulitis
suprascapular nerve block
intra-articular shoulder injection
ultrasonography.
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: randomized, controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in pain on The Shoulder Pain and Disability Index (SPADI) at the tenth day after the injection
timeFrame: baseline and on the tenth day after the injection
measure: The effectiveness of suprascapular nerve block on pain is higher than intra-articular
timeFrame: between before treatment and on the tenth day after the injection
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hitit University
Study officials:
References: