- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05668286
Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis.
Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis. A Prospective, Randomized and Single-blind Study
Study Overview
Status
Conditions
Detailed Description
Purpose:
To compare the intra-articular steroid administration with the extra-articular one; around the coracohumeral ligament in patients with adhesive capsulitis.
Method:
Ethics committee approval was obtained for the study. Patients who were diagnosed with adhesive capsulitis in the orthopedic outpatient clinic were included. Diagnosis was confimed by physical examination and Magnetic Resonance Imaging (MRI) findings. Patients with radiological finding of any tear in the rotator cuff or long head of biceps tendons were excluded. Only patients in the freezing or frozen stage of the disease were included. Patients who were previously treated with the diagnosis of adhesive caspulitis or who received any injections to the shoulder joint were not included in the study. Included patients were randomly divided into two groups according to age, sex, duration of complaint, concomitant diabetes mellitus (DM) disease and clinical stage of the disease. For randomization, stratified randomization was applied according to the information obtained from the outpatient clinic. While patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance. A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients. Patients were first evaluated before injection, than randomized to groups and prospectively followed up by an orthopaedic surgeon who was blinded to the groups. Evaluation was done for pain (visual analog scale score; VAS), functional status (American Shoulder and Elbow Surgeons score; ASES and Quick Disabilities of the Arm, Shoulder and Hand; Quick DASH), and active shoulder joint range of motion (ROM) angles at 1, 3, and 6 weeks after the injection. Means and standard deviations of were noted for each measurement period and each group. Improvements in each period between the groups and differences between the preinjection values and each follow-up period between the groups were analyzed using Ficher exact test, independent-samples t tests and Manova test. P < .05 was considered significant.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: OMER FARUK SEVIM, MD
- Phone Number: +905382884306
- Email: dromerfaruksevim@gmail.com
Study Locations
-
-
Kartal
-
Istanbul, Kartal, Turkey
- Recruiting
- Kartal Dr Lutfi Kirdar City Hospital
-
Contact:
- Omer Faruk Sevim
- Phone Number: +905382884306
- Email: dromerfaruksevim@gmail.com
-
Contact:
- Selim Ergun
- Phone Number: +90 533 601 14 72
- Email: drselimergun@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- must be between the ages of 18-75
- clinically and radiologically confirmed adhesive capsulitis
Exclusion Criteria:
- Patients with a tear in any of the rotator cuff tendons
- Patients who have had steroid injections in the shoulder region before
- patients who have been treated with the diagnosis of adhesive capsulitis (except for oral non-steroidal anti-inflammatory drug therapy)
- Patients with a previous history of trauma-fracture-dislocation in the shoulder region
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: posterior intra-articular steroid injection under USG guidance
Intra-articular steroid injection will be performed to the glenohumeral joint from the posterior, 2cm inferior and 2cm medial of the acromion posterolateral corner, under the guidance of USG.
|
patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance.
A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients.
|
Active Comparator: anterior extra-articular steroid injection under USG guidance
Steroid injection will be performed from the anterior, immediately lateral to the coracoid process, to the CHL localization, to the extra-articular area under the guidance of USG.
|
patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance.
A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Visual Analogue Scale(VAS)
Time Frame: The change from the baseline of the Visual Analog Scale (VAS) score of the shoulder pain in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
|
The change of Visual Analogue Scale (VAS) measures pain intensity.
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Ask the patient to rate their current level of pain by placing a mark on the line.We noted the changes within this scoring system between the time framed which is stated below
|
The change from the baseline of the Visual Analog Scale (VAS) score of the shoulder pain in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
|
external rotation of shoulder
Time Frame: The change from the baseline of external rotation of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
|
The change of external rotation of the shoulder will be measured by the Orthopedic Resident by goniometer.
|
The change from the baseline of external rotation of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
|
abduction of shoulder
Time Frame: The change in shoulder abduction from the baseline over a 6-week period Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
|
The change of abduction of the shoulder will be measured by the Orthopedic Resident by goniometer.
|
The change in shoulder abduction from the baseline over a 6-week period Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
|
flexion of shoulder
Time Frame: The change from the baseline of flexion of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
|
The change of flexion of the shoulder will be measured by the Orthopedic Resident by a goniometer.
|
The change from the baseline of flexion of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
|
Internal rotation of the shoulder
Time Frame: The change from the baseline of internal rotation of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
|
The change of Internal rotation of the shoulder will be measured by the Orthopedic Resident by Constant Shoulder Score
|
The change from the baseline of internal rotation of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Bursitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anesthetics, Local
- Triamcinolone
- Prilocaine
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- KartalCity-ERGUN-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adhesive Capsulitis of the Shoulder
-
Akin CilTerminatedAdhesive Capsulitis of the ShoulderUnited States
-
University of FloridaCompletedAdhesive Capsulitis of the ShoulderUnited States
-
Marmara UniversityCompletedAdhesive Capsulitis of the ShoulderTurkey
-
Daniel G. RendeiroCompletedAdhesive Capsulitis of Shoulder | Frozen Shoulder | Shoulder Adhesive CapsulitisUnited States
-
Vanderbilt University Medical CenterOrthopedic Research and Education FoundationCompletedAdhesive Capsulitis | Frozen Shoulder | Adhesive Capsulitis of Unspecified ShoulderUnited States
-
University of VirginiaRecruitingAdhesive Capsulitis of Shoulder | Adhesive Capsulitis | Frozen ShoulderUnited States
-
University of MalayaNot yet recruitingAdhesive Capsulitis of Shoulder
-
Taipei Veterans General Hospital, TaiwanRecruitingAdhesive Capsulitis of ShoulderTaiwan
-
Taif UniversityRecruitingAdhesive Capsulitis of ShoulderSaudi Arabia
-
Cairo UniversityNot yet recruitingAdhesive Capsulitis of Shoulder
Clinical Trials on A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%)
-
Weill Medical College of Cornell UniversityCompletedNail Diseases | Nail PsoriasisUnited States
-
Kadmon Corporation, LLCQuotient SciencesCompletedHealthy VolunteersUnited Kingdom
-
Montefiore Medical CenterTerminatedHidradenitis SuppurativaUnited States
-
Fondazione Poliambulanza Istituto OspedalieroCompleted
-
Sunnybrook Health Sciences CentreRecruitingGlaucoma | Choroidal EffusionsCanada
-
Columbia UniversityUniversity of MinnesotaTerminated
-
Diakonhjemmet HospitalHelse Stavanger HF; St. Olavs Hospital; Nordlandssykehuset HF; Haugesund Rheumatism... and other collaboratorsRecruitingOsteoarthritis ThumbNorway
-
Clinica Dermatologica Arbache ltdaRecruitingLichen Sclerosus of External Female Genital OrgansBrazil
-
University of North Carolina, Chapel HillCompletedHidradenitis SuppurativaUnited States
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaUnknown