The comparison of clinical outcome of early motion versus late motion following arthroscopic repair of rotator cuff tearing; Randomized Clinical Trial Study
General and specific goals
- The main objectives of the project: to compare the effect of physiotherapy immediately and 4 weeks after arthroscopic repair of small and medium rotator cuff tears on the result
Therapy: A clinical trial study
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, was performed on 22 patients and Excel software rand function was used for randomization.
Settings and conduct
Procedure
22 patients undergoing arthroscopic treatment of small to medium rotator cuff tears in Tehran at Imam Khomeini Hospital
Are included in the study. All repairs are performed with the same technique
Maybe. After the operation, patients will be randomly divided into one of two groups using a table of random numbers. first group
They are introduced to physiotherapy immediately after the operation, but the second group will start physiotherapy after 4 weeks. One-sided study
Will be blind and the physician evaluating the effect of the treatment is in groups {immediately after surgery and 4 weeks after} unaware.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with full-thickness rotator cuff rupture detected by MRI, including patients with acute rupture or chronic rupture
Fractures that involve only the supraspinatus and are in grade 1 or grade 2 coronary MRI
Exclusion criteria:
1 - Age under 18 years
2 - Other diseases of the shoulder joint such as infection, avascular necrosis, and so on
Intervention groups
We divided the patients into two groups. The group for whom physical therapy is started immediately after rotator cuff arthroscopic repair. The second group is immobilized for 4 weeks and after 4 weeks physiotherapy is started.
The comparison of clinical outcome of early motion versus late motion following arthroscopic repair of rotator cuff tearing; Randomized Clinical Trial Study
Public title
The comparison of clinical outcome of early motion versus late motion following arthroscopic repair of rotator cuff tearing; Randomized Clinical Trial Study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with full-thickness rotator cuff rupture diagnosed by MRI include patients with acute rupture or chronic rupture
Ruptures involving only the supraspinatus on a grade 1 or grade 2 coronary MR
Exclusion criteria:
1 - Age under 18 years
2 - Other diseases of the shoulder joint such as infection, avascular necrosis and so on
Major medical disease that makes it unlikely to live under 2 years
4. A specific psychiatric illness that impairs the possibility of conscious satisfaction
.5 - Inability to speak or read Persian
6 - Large ruptures or massive rotator cuff with extension to the subscapularis and minor fear
7 - Simultaneous pathology in labrum that requires surgery
8 - Simultaneous pathology in the acromioclavicular joint that requires distal clavicle resection.
9- Age over 70 years
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
1
Each sample is either in the physiotherapy category immediately after surgery or in the physiotherapy category with a delay of 4 weeks
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the restricted randomization method
randomization (block randomization type
randomization (we will use. blocking usually in order
Balance the number of samples assigned to each group
To be used in the study. This feature helps researchers to
Items that require intermediate analyzes during the sampling process
The number of samples assigned to each of the case groups
The study is equal. The size of all the blocks is equal and we are in this
Two-group trial of 6 blocks (including 3 participants in
We will have an intervention group and 3 participants in the control group. Randomization tools are also used in sequence generation software
Random (software allocation Random) is used that
Random sequence generation software in addition to simple randomization capable
To produce random sequences by block generation method. For hiding
We avoid concealment allocation
We use the method used to execute the sequence
Random refers to study participants, in a way
That before the individual is assigned, the assigned group is not specified. With
From opaque envelopes sealed in random sequence
(envelopes opaque, sealed, numbered Sequentially )
This method uses each of the random sequences created on a card
It is registered and the cards are placed in the letter envelopes in order
To be. In order to maintain a random sequence, also on the outer surface of the envelope
The numbering is done in the same way. Finally the envelope door
The letters are pasted and placed in a box, respectively. At
Time to start registration of participants, based on the order of entry of the company
Eligible applicants to open one of the envelopes in order
And the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be blinded one way. Patients according to type
Interventions will not be blinded. The researcher must enter the data into the checklist
The corresponding slow will be blinded to the type of intervention. The person in charge of the clinical care of the patients, as well as the physiotherapist, will not be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran, Keshavarz Blvd., Imam Khomeini Hospital
City
tehran
Province
Tehran
Postal code
1399/06/12
Approval date
2020-09-01, 1399/06/11
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.205
Health conditions studied
1
Description of health condition studied
Arthropocytic treatment of rotator cuff tear
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
Description
In this study, we want to compare the amount of shoulder forward flexion based on the physiotherapy group immediately and the physiotherapy group 4 weeks later.
Timepoint
It is at intervals of 3, 6 weeks, 3, and 6 months after rotator cuff arthroscopic repair. weeks, 3 months, and six months. will be measured
Method of measurement
With a questionnaire and through the scoring system is the Constant Murley scoring system, which scores between zero and one hundred.
Secondary outcomes
1
Description
Ultrasound 6 after arthroscopic repair of rotator cuff tearing
Timepoint
6 months after surgery
Method of measurement
By sonography and according to the criteria of Sugaya and radiologist
Intervention groups
1
Description
Intervention group: Physiotherapy is performed immediately after arthroscopic repair surgery, ie from the day after the operation. The duration of each session is 30 minutes and 3 sessions per week and the total number of sessions is 30 sessions. TENS, IR, EXE, US modals will be used equally in all patients. All patients with inactive shoulder movements will start from the first session. . All patients will receive physiotherapy at a center by a physiotherapist.
Category
Rehabilitation
2
Description
Control group: Shoulder physiotherapy 4 weeks after arthroscopic repair surgery begins as 3 sessions of shoulder physiotherapy per week with 30 sessions with the emphasis on passive movements and performing tens and exercise and ultrasound and IR.