An interventional study of A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) in Adhesive Capsulitis of the Shoulder, sponsored by Kartal City Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Kartal City Hospital · Not applicable, Interventional, and Treatment
In the treatment of adhesive capsulitis, conservative treatment usually gives successful results, and steroid injection is an effective method that is frequently preferred among conservative treatment modalities. However, many controversial issues have not yet been clarified in the literature, such as the location of the injection, whether into the glenohumeral joint or around the coracohumeral ligament where the most radiological findings are detected.
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.
411 studies on the registry are indexed under Bursitis; 113 are open to participants now.
This study's planned enrollment of 50 is above the median of 45 across 371 interventional studies indexed under Bursitis.
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Exclusion Criteria:
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.
Drug: A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%)
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.
Drug: A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%)
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.
The Visual Analogue Scale(VAS)
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
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.
external rotation of shoulder
The change of external rotation of the shoulder will be measured by the Orthopedic Resident by goniometer.
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.
abduction of shoulder
The change of abduction of the shoulder will be measured by the Orthopedic Resident by goniometer.
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.
flexion of shoulder
The change of flexion of the shoulder will be measured by the Orthopedic Resident by a goniometer.
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.
Internal rotation of the shoulder
The change of Internal rotation of the shoulder will be measured by the Orthopedic Resident by Constant Shoulder Score
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.
Plan to share: Yes — All the criteria specified and to be observed regarding the study will be transferred to the system in a timely manner and will be observed by the researchers outside the personal information of the patients.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Kartal City Hospital