Evaluation of the repair process of thumb flexor tendons after Botox injection in the thumb flexor muscles

Determining the effect of Botox injection on the repair process of thumb flexor tendons

A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 100 patients. Balanced block randomized method is used for randomization.

This is a clinical trial study on deep flexor tendon of the thumb which will be performed on 100 people who are between 15 and 50 years old by the Kessler method in Shahid Rajaei Hospital, Qazvin province. One hour before surgery, Botox will be injected into the intervention group, after the surgery, a plaster cast is performed for 4 weeks, and after removing the plaster, physiotherapy is performed for 3 months. It is a double-blind type. Based on what is mentioned in the consent form, patients will be blind. Since the writing of the article will be done by the surgeon, so blinding will not be done him. Nurses and especially physiotherapists are blind to the intervention.

Patients aged 15 to 50 who have acute damage to the deep flexor tendons of the thumb and refer to the surgical clinic of Shahid Rajaei Hospital in Qazvin. Provide written consent to enter the study

Control group: After the surgery, control group is casted for 4 weeks, after removing the cast, physiotherapy will be done for 3 months in the control group. Intervention group: One hour before the start of the reconstructive surgery, between 50 and 100 units of botulism toxin along with 10 ml of normal saline are injected into the flexor pollicis longus (FDL) muscle. Injected botulism is produced by Diston brand of Imen Vaccine pharmaceutical company.After surgery, intervention group is casted for 4 weeks. After removing the cast, physiotherapy will be done for 3 months in intervention group.

Evaluation of joint movement limitation in each group.

Patients are assigned randomly in a double-blind manner in the control or intervention groups based on the Balanced Block Randomization method into two groups A and B in blocks AABB-BBAA- ABAB-BABA-ABBA-BAAB which are 4 blocks.

This is a double-blind type of experiment that will be blind for the people participating in the study. In the consent form to participate in the study, it is written for the patient that his presence does not necessarily mean intervention but may be included in the control group. The main investigator of the study in this trial will not be blind because he will be the final evaluator of the results between the two groups. Since the writing of the article will be done by the main researcher, who is responsible for the project and the analysis of the results at the end, blinding will not be done for him. In addition, considering that this is a study that takes place during hand tendon surgery, it is practically not possible to keep the intervention blind for the surgeon, although the nurses and especially the physiotherapist will be blind to the intervention.

all variables and total potential data can be shared after people are identifiable

start access period 6 months after printing results

It will be available to researchers working in academic institutions.

The data can be reviewed and used to improve clinical conditions and maintain patient health and perform meta-analyzes.

They can request the author's email or from the research center or university.

Apply by email or post to Qazvin University of Medical Sciences.