]>
IRCT20161221031506N10 IRCT 2023-11-26 Mashhad University of Medical Sciences Comparison of Drug Injection and Physiotherapy in patients diagnosed with Frozen Shoulder The short-term Effect of adding Subacromial Corticosteroid Injection to Physiotherapy on Pain, Disability, and Effectiveness of Treatment in Patients with Frozen Shoulder: Randomized Controlled Trial 2023-11-22 anticipated 48 Complete https://irct.ir/trial/72903 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using stratified randomization, two indexes of numbers 1 and 2, which belong to physiotherapy (number 1) and physiotherapy with injection (number 2), respectively, will be generated from "sealedenvelope.com" and put into opaque, sealed envelopes. One group of envelopes belongs to diabetic patients and the other group, to non-diabetic patients. Based on the mean and standard deviation of the SPADI questionnaire score in similar Studies, while considering a 10% drop rate, 24 subjects will be allocated to each group, Blinding description: Participants will choose from sealed, opaque envelopes. Another physiotherapist who is not aware of the allocation will evaluate the patients in a separate room. Data analyser will be blinded when performing statistical analysis using codes A and B for intervention groups in the statistical analysis software. N/A Adhesive capsulitis of shoulder (Frozen Shoulder). Intervention 1: Intervention group: First, the treatment will be performed by injecting 1 cc of triamcinolone (40 mg) and 9 cc of 2% lidocaine as a side injection in the subacromial space. After 24 hours of treatment, they will receive 10 sessions of physiotherapy 3 sessions a week. In this group, after applying the hot pack for 15 minutes, a low-power laser will be applied for 30 seconds at 8 painful points of the shoulder joint capsule with 1.8 joules of energy at each point. After that, grade 2 mobilization of the glenohumeral joint will be done in the direction of abduction and external rotation. Then, the second diagonal pattern of flexion in the upper limb in the involved hand along with the Hold-Relax technique will be performed in the form of 10 seconds of contraction of the antagonist muscle, 5 times in each session. Intervention 2: Control group: In physiotherapy group, who will receive 10 sessions, 3 sessions weekly, after hot pack application for 15 minutes, low level laser with 1.8 joules of energy per point will be applied for 30 seconds on 8 painful points of the glenohumeral capsule. Afterwards, a grade 2 glenohumeral mobilization for improving Abduction and External Rotation will be applied. Finally, the D2 flexion pattern of the involved extremity accompanied by Hold Relax technique, performed with 10 seconds of antagonist muscle contraction, will be applied 5 times per each session. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Reyhane Rastgou
Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3869 8719 rastgour4001@mums.ac.ir Mashhad University of Medical Sciences scientific Reyhane Rastgou
Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3869 8719 rastgour4001@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients older than 18 years Abduction and External rotation limitation (More than 50% of normal range) A minimum history of 4 weeks of Shoulder pain Absence of coagulative diseases Sleep disturbances due to pain and incapability of sleeping on the affected side 18 years no limit Both History of severe trauma to the shoulder History of neck radiculopathy History of complete Rotator Cuff tear Severe infection History of Glenohumeral joint fracture Presence of malignancy in Shoulder 4 to 6 months after Radiotherapy in Shoulder Injection contraindications (Allergic to Drug, etc) M75.0 Adhesive capsulitis of shoulder Rehabilitation Rehabilitation Intervention group: First, the treatment will be performed by injecting 1 cc of triamcinolone (40 mg) and 9 cc of 2% lidocaine as a side injection in the subacromial space. After 24 hours of treatment, they will receive 10 sessions of physiotherapy 3 sessions a week. In this group, after applying the hot pack for 15 minutes, a low-power laser will be applied for 30 seconds at 8 painful points of the shoulder joint capsule with 1.8 joules of energy at each point. After that, grade 2 mobilization of the glenohumeral joint will be done in the direction of abduction and external rotation. Then, the second diagonal pattern of flexion in the upper limb in the involved hand along with the Hold-Relax technique will be performed in the form of 10 seconds of contraction of the antagonist muscle, 5 times in each session. Control group: In physiotherapy group, who will receive 10 sessions, 3 sessions weekly, after hot pack application for 15 minutes, low level laser with 1.8 joules of energy per point will be applied for 30 seconds on 8 painful points of the glenohumeral capsule. Afterwards, a grade 2 glenohumeral mobilization for improving Abduction and External Rotation will be applied. Finally, the D2 flexion pattern of the involved extremity accompanied by Hold Relax technique, performed with 10 seconds of antagonist muscle contraction, will be applied 5 times per each session. Pain. Timepoint: Immediately After Allocation, 6 weeks after Randomization. Method of measurement: Shoulder Pain and Disability Index (SPADI) questionnaire, Visual Analogue Scale. Disability. Timepoint: Immediately After Allocation, 6 weeks after Randomization. Method of measurement: Shoulder Pain and Disability Index (SPADI) questionnaire. The Effectiveness of Treatment. Timepoint: 6 weeks after randomization. Method of measurement: Global Rating of Change Scale. Mashhad University of Medical Sciences Approved 2023-08-19 The Ethics Committee of Mashhad University of Medical Sciences Mashhad University of Medical Science's Research and Development Deputy Office, Across 18th University Street, University Street. Mashhad Razavi Khorasan Iran (Islamic Republic of)