NCT05909462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 1, 2023

Last Update Submit

June 11, 2023

Conditions

Keywords

Adhesive capsulitissuprascapular nerve blockintra-articular shoulder injectionultrasonography.

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

suprascapular verve block

EXPERIMENTAL

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

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

intraarticular shoulder injection

EXPERIMENTAL

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

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

Interventions

ultrasonography-guided suprascapular nerve block and intra-articular shoulder injection

Also known as: intra-articular shoulder injection
intraarticular shoulder injectionsuprascapular verve block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University

Çorum, 19030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis

Interventions

Triamcinolone AcetonideLidocaine

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blind randomized controlled
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: randomized, controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 18, 2023

Study Start

January 21, 2023

Primary Completion

April 24, 2023

Study Completion

May 24, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
21/01/2023-24/05/2023

Locations