IRCT | Comparison of the short-term effects of routine physiotherapy and physiotherapy with emphasis on the scapulothoracic joint on pain, range of motion, functional ability and quality of life after arthroscopic shoulder rotator cuff tendon repair.

Protocol summary

Study aim: The aim of this study is to compare the effect of routine physiotherapy and physiotherapy focusing on scapulothoracic joint in patients with rotator cuff arthroscopic repair.
Design: A two-arm pragmatic, parallel-group, single-blind, randomized controlled trial
Settings and conduct: Patients' surgery is performed by an orthopedic specialist and after the operation and evaluation, if they are eligible to enter the study, they are referred to the special physiotherapy clinic of Ghaem Hospital. The assessor and statistician will be blind to the groupings during the project. Random grouping of people will be done by sealed envelopes
Participants/Inclusion and exclusion criteria: Inclusion criteria: Patients aged 30-75 years • The origin of the rupture should be progressive damage • The size of the rupture is small and medium (= <3 cm) Exclusion criteria: • Any complication in the shoulder girdle area such as arthritis of the shoulder joint or destructive joint disease as well as SLAP and Bankart surgery • Traumatic tears that result from direct trauma or injury and tears larger than 3 cm • Existence of neurological disorders such as disorders Neurological with sensory and muscular problems • Radicular pain from the neck or chest • History of fracture, dislocation, or shoulder complex surgery
Intervention groups: In the routine physiotherapy group, the treatment program includes pendulum exercises, stretching techniques, manual techniques, and the rotator cuff muscle strengthening program. Therapeutic modalities are also used in each session. In the comprehensive physiotherapy group, in addition to the treatment program mentioned in the routine group, manual techniques include manual therapy of the scapula and thoracic spine, training of the correct position of the scapula at rest, movement control.
Main outcome variables: Pain, Range of Motion, Disability, Functional level, Quality of life

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20201010048978N1

Registration date: 2021-04-20, 1400/01/31

Registration timing: retrospective

Last update: 2021-04-20, 1400/01/31

Update count: 0
Registration date: 2021-04-20, 1400/01/31

Registrant information: Name

Marzieh Rezaie

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 51 3513 7115

Email address

rezaeimr961@mums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2020-09-13, 1399/06/23
Expected recruitment end date: 2021-03-13, 1399/12/23
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the short-term effects of routine physiotherapy and physiotherapy with emphasis on the scapulothoracic joint on pain, range of motion, functional ability and quality of life after arthroscopic shoulder rotator cuff tendon repair.

Public title: The comparative effect of two methods of rehabilitation in patients after arthroscopic shoulder rotator cuff tendon repair.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patients aged 30-75 years The origin of the rupture should be progressive damage The size of the rupture is small and medium (= <3 cm) Patients with complete rupture of the rotator-cuff muscles except subscapularis Since this operation is usually performed in conjunction with other restorative procedures such as subacromial decompression and distal clavicle resection; to increase the generalizability to the community in this study, patients can be accompanied by these operations.

Exclusion criteria:

Any complication in the shoulder girdle area such as arthritis of the shoulder joint or destructive joint disease as well as SLAP and Bankart surgery Traumatic tears that result from direct trauma or injury and tears larger than 3 cm Existence of neurological disorders such as disorders Neurological with sensory and muscular problems Radicular pain from the neck or chest (Increased/developed shoulder symptoms with active or inactive neck movement) History of fracture, dislocation or shoulder complex surgery History of RSD History of recurrent dislocation or joint instability Shoulder in the last 3 months Symptoms of preoperative capsular adhesion characterized by a loss of more than 50% of inactive range of motion compared to the non-involved side in at least two shoulder movements
Age: From 30 years old to 75 years old
Gender: Both

Phase

N/A

Groups that have been masked

Investigator
Outcome assessor
Data analyser

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

Randomization description

In the present study, randomization is performed by an independent therapist using the block randomization method. In order to assign 15 patients in each group equally, we will use numbers between 1 and 30 for randomization, with even numbers representing the intervention group and odd numbers representing the control group. The reason for performing block randomization is to have the same number of samples in each group. The numbers are written on paper and placed in opaque sealed envelopes, and stamped. Those who meet the inclusion criteria are asked to pick up an envelope, and depending on whether the number in the envelope is even or odd, the patient will be randomly assigned.

Blinding (investigator's opinion)

Single blinded

Blinding description

The trial assessor and statistician were blinded to the treatment allocation throughout the study period.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

The Ethics Committee of Mashhad University of Medical Sciences

Street address

Opposite University Street 18, University street

City

Mashhad

Province

Razavi Khorasan

Postal code

9138813944
Approval date: 2020-09-12, 1399/06/22
Ethics committee reference number: IR.MUMS.REC.1399.415

Health conditions studied

1

Description of health condition studied: Complete rotator cuff tear or rupture not specified as traumatic
ICD-10 code: S46.0
ICD-10 code description: Injury of muscle(s) and tendon(s) of the rotator cuff of shoulder

Primary outcomes

1

Description: Pain intensity
Timepoint: Before the start of the treatment plan/after the completion of the treatment plan
Method of measurement: Visual Analogue Scale (VAS)

Secondary outcomes

1

Description: Range of motion
Timepoint: Before the start of the treatment plan (two weeks after the surgery) and after the completion of the treatment plan (9 weeks after the surgery)
Method of measurement: Goniometer

2

Description: Disability
Timepoint: Before the start of the treatment plan (two weeks after the surgery) and after the completion of the treatment plan (9 weeks after the surgery)
Method of measurement: SPADI questionnaire

3

Description: The quality of life
Timepoint: Before the start of the treatment plan (two weeks after the surgery) and after the completion of the treatment plan (9 weeks after the surgery)
Method of measurement: Western Ontario Rotator cuff index questionnaire(Worc)

4

Description: The effectiveness of treatment
Timepoint: Before the start of the treatment plan (two weeks after the surgery) and after the completion of the treatment plan (9 weeks after the surgery)
Method of measurement: Global Rating of Scale(GRC) questionnaire

5

Description: Functional level
Timepoint: Before the start of the treatment plan (two weeks after the surgery) and after the completion of the treatment plan (9 weeks after the surgery)
Method of measurement: ASES questionnaire

Intervention groups

1

Description: Intervention group: Postoperative information and intervention if eligible to enter the study after 2 weeks of a rehabilitation program. Physiotherapy treatment in both groups was 21 sessions in 7 consecutive weeks and three sessions per week. Besides the conventional physiotherapy program, this program includes manual techniques to help the scapula and thoracic spine, training the correct position of the scapula at rest, movement control and strengthening of the lower, middle, and serratus trapezius, along with exercises to facilitate multifunctional deep sensation.
Category: Rehabilitation

2

Description: Control group: After surgery and evaluation, patients will start a rehabilitation program after 2 weeks if they are eligible to enter the study. Physiotherapy treatment is 21 sessions that will be done in 7 consecutive weeks and three sessions per week. This rehabilitation program includes: pendulum exercises, stretching techniques, manual techniques including manual treatment of glenohumeral joint (lower and posterior glide of the humerus) and rotator cuff muscle strengthening program. Therapeutic modalities are also used in each session.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Physical Therapy Clinic of Ghaem Hospital

Full name of responsible person

Mr Javad Zarandi

Street address

Nursing door entrance, right side, library side, Narjes building, first floor,Physiotherapy Department, Ghaem Hospital,

City

Mashhad

Province

Razavi Khorasan

Postal code

9176699199

Phone

+98 51 3841 1538

Email

ZarandiMJ1@mums.ac.ir

1

Sponsor: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Dr.Mohsen Tafaghodi

Street address

Doctora cross road, Ghoreshi building

City

Mashhad

Province

Razavi Khorasan

Postal code

9919191778

Phone

+98 51 3841 1538

Fax

+98 51 3843 0249

Email

vcresearch@mums.ac.ir

Web page address

http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Mashhad University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Marzie Rezaee

Position

MSc student

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

Azadi square, East door of Ferdowsi University of Mahhad, University campus, Faculty of paramedical sciences

City

Mashhad

Province

Razavi Khorasan

Postal code

9177948964

Phone

+98 51 3513 7115

Email

Marzie.rezaee73@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Marzie Rezaee

Position

MSc student

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

Azadi square,East door of Ferdowsi university of Mashhad,university campus,Faculty of paramedical sciences

City

Mashhad

Province

Razavi Khorasan

Postal code

9177948964

Phone

+98 51 3513 7115

Email

Marzie.rezaee73@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Marzie Rezaee

Position

MSc student

Latest degree

Bachelor

Other areas of specialty/work

Physiotherapy

Street address

Azadi square, East door of Ferdowsi University of Mashhad, university campus, Faculty of paramedical sciences

City

Mashhad

Province

Razavi Khorasan

Postal code

9177948964

Phone

+98 51 3713 9981

Email

Marzie.rezaee73@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document: All reports will be reported in one research paper.Raw data will be delivered to researchers for meta analysis.
When the data will become available and for how long: starting 6months after publication.
To whom data/document is available: For researchers
Under which criteria data/document could be used: Only for meta-analysis
From where data/document is obtainable: marzie.rezaee73@gmail.com
What processes are involved for a request to access data/document: The response will be sent within 3months after considering the researcher`s request.
Comments

Comparison of the short-term effects of routine physiotherapy and physiotherapy with emphasis on the scapulothoracic joint on pain, range of motion, functional ability and quality of life after arthroscopic shoulder rotator cuff tendon repair.