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IRCT20220403054400N1 IRCT 2022-08-31 Shahid Beheshti University of Medical Sciences Comparison of Functional Improvement and Pain Relief in Frozen Shoulder after treatment of Prolotherapy and Exercise with Exercise alone :RCT Comparison of Functional Improvement and Pain Relief in Frozen Shoulder after treatment of Prolotherapy and Exercise with Exercise alone :RCT 2022-04-22 anticipated 40 Complete https://irct.ir/trial/63103 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is of the type of clinical trial studies that through simple randomization of 40 patients referred to the Physical Medicine and Rehabilitation Clinic of Shahada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, who have signs and symptoms of frozen shoulder based on history and examination. and are in the initial phase of the disease (at most 4 months have passed since the onset of the disease symptoms), they are divided into two arms (through a sealed envelope that was in the form of A and B and the participant in the study did not know the type of intervention) And they will be examined based on the entry and exit criteria of the study. In terms of blinding, in this study, the blinding process will be done for the participant and the data analyst. In this way, after assigning people to the arms, the main researcher will have access to the type of intervention of each person and after collecting the data, the data will be presented as two groups A and B to the analyst for data analysis. After analyzing the data, the obtained information will be analyzed by the researcher, Blinding description: The participants in the study were divided through a sealed envelope that was in the form of A and B, and the participant in the study did not know the type of intervention, and after assigning people to the arms, the main researcher will have access to the type of intervention of each person Collecting data, the data is presented in two groups, A and B, to the individual analyst for data analysis. After analyzing the data, the obtained information will be analyzed by the researcher. N/A Frozen shoulder. Intervention 1: Intervention group: Patients will be treated with intra-articular injection of 5 cc dextrose solution 50% with 2.5 cc lidocaine and 2.5 cc of distilled water with ultrasound guid and ROM exercise and stretching exercise will be taught to the patient. Intervention 2: Control group: In case of pain, the patient can use acetaminophen 500mg without codeine. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Zahra Safaei
Department of Physical Medicine and Rehabilitation, Shohadash Hospital ,Tajrish Street
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 zahrasafaei1994@yahoo.com Shahid Beheshti University of Medical Sciences scientific Zahra Safaei
Department of Physical Medicine and Rehabilitation, Shohadash Hospital , Tajrish Street
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 zahrasafaei1994@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) In the first stage of frozen shoulder (in painful phase) (maximum 4 months past the onset of the disease). - Have the consent and willingness to participate in the study. 18 years 75 years Both In the first stage of frozen shoulder (in painful phase) (maximum 4 months past the onset of the disease). - Have the consent and willingness to participate in the study. M75.0 Adhesive capsulitis of shoulder Treatment - Drugs Treatment - Other Intervention group: Patients will be treated with intra-articular injection of 5 cc dextrose solution 50% with 2.5 cc lidocaine and 2.5 cc of distilled water with ultrasound guid and ROM exercise and stretching exercise will be taught to the patient. Control group: In case of pain, the patient can use acetaminophen 500mg without codeine. Comparison of the effect of prolotherapy with exercise and exercise alone in reducing pain based on VAS, and comparing the performance based on Oxford shoulder score and range of motion of internal and external rotation and flexion by goniometer, investigating the prevalence of frozen shoulder based on sex. Timepoint: 2 weeks & 6 weeks. Method of measurement: Comparison of the effect of prolotherapy with exercise and exercise alone in reducing pain based on Visual Analogue Scale, and comparison of Oxford shoulder score and range of motion of internal and external rotation and flexion by gunometer, evaluation of the prevalence of frozen shoulder based on sex. Shahid Beheshti University of Medical Sciences Approved 2022-02-18 Ethics committee of Shahid beheshti University of Medical Sciences Department of Physical Medicine and Rehabilitation, Shohadash Hospital , Tajrish Street tehran Tehran Iran (Islamic Republic of)