Evaluation of weight bearing exercises on pain and physical function of patients with knee osteoarthritis treated by implantation of autologous bone marrow derived mesenchymal stromal cells.

Evaluation of the effect of weight-bearing and non-weight-bearing exercises on pain and function in patients with osteoarthritis of the knee treated with bone marrow-derived mesenchymal stromal cells

This clinical trial consisted of two parallel groups, one-way blind, randomized, on 40 patients to perform movements with weighting and without weighting on the knee joint. Stratified Block Randomization is used for randomization.

This trial will be performed on 40 patients with knee osteoarthritis who have undergone stromal cell therapy at Royan Institute. Patients are randomly divided into two groups of 20 and for one group weight bearing exercises with on the knee joint and in the second group exercises without weight bearing will be performed. Exercises will be described to patients by the physician and will be evaluated and compared before, 1 month after, and 3 months after the intervention. The project will be implemented in Taleghani Hospital. Only the statistical analyzer will be blind to the type of treatment.

Inclusion criteria: Patients with osteoarthritis of the knee treated by autologous bone marrow derived mesenchymal stromal cells; Non-entry conditions: Uncontrolled diseases that interfere with the intervention process. For example, the patient may not be able to attend regular exercise therapy sessions to pursue treatment for his or her uncontrolled disease.

Group A: Weigh bearing Exercises Group B: None weigh bearing Exercises

Patient pain and functional status

The method of assigning the subjects after applying the entry and exit criteria will be random allocation by permutation block method. The randomization unit is individual. The size of the blocks is 4 and in each block, each intervention group will be repeated twice. As a result, we will have 6 different blocks, each of which will be numbered from 1 to 6 as desired. Then, using the rdunif statistical program code (n = 10, b = 6, a = 1) in R software version 3.6.1, 10 blocks of 4 will be generated, which will produce a total of 40 sequences. (It should be noted that this code generates ten random numbers from the numbers 1 to 6, which are the number of blocks). Using this randomly generated list, patients will be placed in the intervention group (exercise therapy with weight bearing) and the control group (exercise therapy without weight bearing). To hide the random allocation list, a special code will be assigned to each of the intervention groups that only the main executor of the project is aware of. These codes are written on a piece of paper and placed in a sealed envelope. A unique code that is specific to each patient will be written on this paper as well as its envelope. A foil is also placed inside each envelope so that the envelopes are not legible under light. Each envelope also contains a white paper and a carbon. All envelopes are placed in a larger box in random order and will be sealed in the box. The main researcher, after reviewing the inclusion criteria and obtaining informed consent, as well as registering the patient's details in a special form, will contact the partner who has a random assignment list (except for the main researcher who is not involved in the patient recruitment and sample entry process). And the patient is randomized. Also, before opening the envelope, this person must write the name and surname and age of the person on the place marked on the envelope so that its copy falls on the paper inside the envelope.

In this study, due to the nature of this trial, that requires exercise by volunteers, only statistical analyzer blinding will be possible, and volunteers and the evaluating physician who works with both groups of patients are not blind to it. Before the person enters the study, the physician in charge of the project will fully explain to the patient that the people will be randomly placed in each of the two groups and the patient will be fully aware of this. Finally, the statistical analyzer whom will be blind to the data , will analyze it and will not know which treatment protocol is included for each person.

After the end of the study, all the data related to the study, including the main and secondary consequences, will be shared after Unidentifiable the individuals.

Access starts 6 months after the results are published

Researchers working in academic and scientific institutions

The released data can only be used for scientific use by other researchers, and the use of the data will be allowed only with the permission of the physician in charge of this project.

Arabi Ave, Shahid Chamran Blvd, Tehran Mohammad Hassabi 0098 021 22432560 hassabi@yahoo.com

The doctor in charge will be contacted first, after coordination with him, they will receive information via e-mail or in person at their discretion. This process will take 1 to 2 weeks.