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Comparison of the Effects Suprascapular Nerve Block and Intra-articular Shoulder Injection

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine
Sponsored by
Hitit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive capsulitis, suprascapular nerve block, intra-articular shoulder injection, ultrasonography.

Eligibility Criteria

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

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

Sites / Locations

  • Hitit University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

suprascapular verve block

intraarticular shoulder injection

Arm Description

2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine

2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine

Outcomes

Primary Outcome Measures

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
The effectiveness of suprascapular nerve block on pain is higher than intra-articular
Shoulder Pain and Disability Index

Secondary Outcome Measures

Full Information

First Posted
June 1, 2023
Last Updated
June 11, 2023
Sponsor
Hitit University
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1. Study Identification

Unique Protocol Identification Number
NCT05909462
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2023 (Actual)
Primary Completion Date
April 24, 2023 (Actual)
Study Completion Date
May 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Adhesive capsulitis, suprascapular nerve block, intra-articular shoulder injection, ultrasonography.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
randomized, controlled trial
Masking
ParticipantInvestigator
Masking Description
double blind randomized controlled
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
suprascapular verve block
Arm Type
Experimental
Arm Description
2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine
Arm Title
intraarticular shoulder injection
Arm Type
Experimental
Arm Description
2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine
Intervention Type
Drug
Intervention Name(s)
2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine
Other Intervention Name(s)
intra-articular shoulder injection
Intervention Description
ultrasonography-guided suprascapular nerve block and intra-articular shoulder injection
Primary Outcome Measure Information:
Title
Changes from baseline in pain on The Shoulder Pain and Disability Index (SPADI) at the tenth day after the injection
Description
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
Time Frame
baseline and on the tenth day after the injection
Title
The effectiveness of suprascapular nerve block on pain is higher than intra-articular
Description
Shoulder Pain and Disability Index
Time Frame
between before treatment and on the tenth day after the injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hitit University
City
Çorum
ZIP/Postal Code
19030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
21/01/2023-24/05/2023

Learn more about this trial

Comparison of the Effects Suprascapular Nerve Block and Intra-articular Shoulder Injection

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