Comparison of Functional Improvement and Pain Relief in Frozen Shoulder after treatment of Prolotherapy and Exercise with Exercise alone :RCT

Comparison of performance, pain improvement and range of motion in patients with frozen shoulder referring to Shohadaye Tajrish physical medicine clinic in two groups receiving Prolotherapy and exercise and the group receiving exercise

The clinical trial had a control group, with parallel, double-blind groups, randomized, on 40 patients. For randomization, rand function of Excel software was used.

40 patients referred to physical medicine and rehabilitation clinic of Shohada Tajrish Hospital, who have frozen shoulder signs and symptoms, receive written and informed consent based on inclusion and exclusion criteria. Then, the intervention group will be treated with prolotherapy and exercise therapy and the control group will be followed for two weeks and 6 weeks later.

Inclusion criteria include adults with frozen shoulder:Ages 18 to 75 In the first stages of the frozen shoulder (painful phase) (up to 4 months pass since the onset of the disease) Have the consent and willingness to participate in the study.Exclusion criteria: Patients with a history of recent shoulder fractures and trauma, history of inflammation and infection of the joint or active tendonitis, any bone disease of the shoulder, physical history of therapy or any intra-joint injection involved during the past three months, history of NSAID drugs in the last 2 weeks, history of systemic corticosteroid use in the last month, history of shoulder surgery, sensitivity to dextrose or triamcinolone and recurrence of the disease. Shoulder and unwillingness to participate in the study will be excluded.

The two groups receive Exercise + Prolotherapy and the group receiving Exercise.

Evaluation of ROM, pain rate based on VAS, performance based on oxford shoulder score, prevalence of this disease in different sexes

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.

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.

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This study will be conducted blinding process for outcome assessor and analyst. In this way, after assigning people to the arms, only the main researcher will have access to the type of intervention of each individual and the type of intervention on the questionnaire will be as options A (main intervention) and B (control intervention) and the analyst will report the results as differences between groups A and B after the analysis and the main researcher will ultimately determine the type of intervention. After data collection, data will be analyzed by SPSS ver. 25 statistical software. Continuous quantitative variables will be reported by central dispersion indices (mean and standard deviation). K-S test will also be used to determine the normality of data distribution. Student T Test and Chi Square Test will be used for analysis between groups. P < 0.05 will be considered as a significant level for all tests.

Start access period 6 months after printing results

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To refer the contents

zahrasafaei1994@yahoo.com Zahra Safaei 09122937180 00982122465720 Tehran-Tajrish Square - Shohadaye Tajrish Hospital

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