NCT07364227

Brief Summary

This randomized controlled clinical trial aims to compare the efficacy of three different intra-articular injection approaches (anterior, posterior, and combined anterior-posterior) in patients with adhesive capsulitis of the shoulder. Thirty participants will be randomly assigned to one of three groups and treated with a standardized injection solution consisting of corticosteroid, lidocaine, and saline. Clinical outcomes will be evaluated using pain scores, functional scales, and imaging parameters.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2026Jul 2026

Study Start

First participant enrolled

January 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Keywords

Adhesive Capsulitis of the ShoulderIntra-articular InjectionFrozen ShoulderUltrasoundShoulder Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Shoulder Range of Motion (ROM)

    Change in active and passive shoulder joint range of motion (flexion, extension, abduction, external rotation, internal rotation) measured with a goniometer.

    Baseline, immediately post-injection, week 3, week 6, week 12

Secondary Outcomes (8)

  • Change in Pain Intensity (NRS)

    Baseline, immediately post-injection, week 3, week 6, week 12

  • Subjective Shoulder Value (SSV)

    Baseline, immediately post-injection, week 3, week 6, week 12

  • Shoulder Pain and Disability Index (SPADI)

    Baseline, week 3, week 6, week 12

  • Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)

    Baseline, week 3, week 6, week 12

  • American Shoulder and Elbow Surgeons (ASES) Score

    Baseline, week 3, week 6, week 12

  • +3 more secondary outcomes

Study Arms (3)

Arm A: Posterior Injection

EXPERIMENTAL

Single intra-articular injection with corticosteroid + lidocaine + saline via the posterior glenohumeral approach.

Drug: Intervention Name: Posterior Intra-articular Injection

Arm B - Anterior Injection

EXPERIMENTAL

Same injection solution administered via the anterior (rotator interval) approach.

Drug: Anterior Intra-articular Injection

Arm C - Combined Anterior + Posterior Injection

EXPERIMENTAL

Same injection solution administered using both anterior and posterior approaches.

Drug: Combined Anterior + Posterior Intra-articular Injection

Interventions

A single intra-articular injection consisting of 1 cc corticosteroid, 4 cc 2% lidocaine, and 5 cc saline (total 10 cc) administered using both anterior and posterior approaches during the same procedure.

Also known as: combined joint injection
Arm C - Combined Anterior + Posterior Injection

A single intra-articular injection consisting of 1 cc corticosteroid, 4 cc 2% lidocaine, and 5 cc saline (total 10 cc) administered via the posterior glenohumeral approach.

Also known as: Posterior Intra-articular Injection
Arm A: Posterior Injection

A single intra-articular injection consisting of 1 cc corticosteroid, 4 cc 2% lidocaine, and 5 cc saline (total 10 cc) administered via the anterior (rotator interval) approach.

Also known as: Anterior hydrodilatation
Arm B - Anterior Injection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BursitisShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aslinur keles, MD., PhD

    Health Sciences University Fatih Sultan Mehmet Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aslinur K Keles, MD., PhD

CONTACT

esra K giray, Assoc Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a single-center, randomized, controlled, parallel-group clinical trial with three intervention arms. Thirty patients with adhesive capsulitis will be randomly assigned in equal numbers (1:1:1) to receive an intra-articular corticosteroid injection via the posterior approach, the anterior approach, or a combined anterior-posterior approach. Each participant will receive only one type of injection, and outcomes will be assessed at baseline, immediately post-injection, and at weeks 3, 6, and 12.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

January 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share