Comparative effectiveness of ultra-sound guided injections of corticosteroid and perineural dextrose 5% on clinical appearance, function, sonographic and electrodiagnostic findings in patients with cubital tunnel syndrome, a clinical trial study

Compare the effectiveness of ultra-sound guided injections of corticosteroid and perineural dextrose 5% on clinical appearance, function, sonographic and electrodiagnostic findings in patients with cubital tunnel syndrome

The research is a randomized double blind clinical trial on 22 patients.

Samples are selected from patients with mild to moderate ulnar neuropathy referred to physical medicine and rehabilitation clinics under supervision of shiraz university of medical sciences divided into two groups. Block Randomization Assignment and Double blind methods are used. After obtaining informed consent, In group A corticosteroid is injected under guide of ultrasound and in group B ultrasound guided prineural injection of dextrose 5% is done. Finally effects on clinical appearance, function, sonographic and electrodiagnostic findings are measured.

Inclusion criteria: Patients with age ranged from 20-65 years with diagnosis of mild to moderate ulnar neuropathy. The symptoms and signs persisted for at least 1 month. Exclusion criteria: Patients who are in a severe condition (paresis and muscle atrophy) and have brachial plexus neuropathy, history of elbow trauma or operation, rheumatologic disorder, peripheral neuropathy such as diabetes, previous perineural injection, malignancy, coagulopathy, pregnancy, active infection, or infection of injection site.

Group A will receive locally 1 ml Methyl Prednisolone Acetate 40 mg and 1 ml Normal saline plus 1 ml Lidocaine 2%, under guide of ultrasound, in the cubital tunnel. Group B will receive locally 2 ml D5W plus 1 ml Lidocaine 2% ,under guide of ultrasound, in cubital tunnel.

Pain, Sensory and motor symptoms, Activity of daily living, Cross sectional area of ulnar nerve

There was an error in recording the date of sample collection and in calculating the dates for patient examinations and preparing the necessary conditions to start the work. The correct dates for the intervention and sampling occurred after registration in the IRCT.

Patients will be randomly allocated in to two groups by Block Randomization Assignment and Double blind methods. We will have two lists of 11 patients, including the two intervention and control groups, at random. For concealment, method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by a person unaware of the division of groups.

Participant: in this study, we does not have the ability to blind the participant because the participant is aware of receiving each intervention. Clinical care giver: we teach the caregiver how to complete the questionnaire. This person is not aware of receiving patient’s intervention. Researcher: this study does not have the ability to blind the researcher due to performing both interventions by himself and being aware of receiving the kind of intervention in each group. The outcome assessor of the complete questionnaires is given to a person who is not aware of the intervention performed and he/she is asked to determine the level of performance in each person according to the questionnaires. Data analyzer: questionnaire are finally given to a person to review the information. This person does not know any of the steps of the work and the way of classification in which the intervention performed.

All available data can be shared after making people unidentifiable.

Start access period one year after publishing the results.

Everyone can access to this information.

If the information in this study helps to improve the science process.

Dr. Maryam Mirhadi, 00989177398937, maryam.mirhadii@gmail.com

After sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of three weeks if permitted.