Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05933382 |
| Other study ID # |
MedipolPTR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
February 10, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Istanbul Medipol University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chronic shoulder pain, predominantly caused by rotator cuff disorders represents one of the
most frequently encountered musculoskeletal issues within the community. Rotator cuff tears
are a crucial pathophysiological contributor to shoulder pain. Individuals afflicted with
this condition frequently report nocturnal intensification of pain and movement-specific
aggravation, especially during overhead activities. The condition is frequently correlated
with functional impairment, with many patients noting a sensation of weakness. Conservative
treatment of the rotator cuff tear consists of a wide range of procedures such as exercise
therapy; and/or local anesthetic, ice/heat therapy, electrotherapy, various types of manual
therapy and joint mobilization procedures. Corticosteroid injection approach is an
alternative method to these applications The subacromial corticosteroid injection is an
intervention technique that has been utilized for short-term relief over numerous years.Given
the restricted self-repair capabilities of tendons the consideration of novel biological
treatment strategies for tendinopathies has gained prominence in recent times. Nonetheless,
there remains a lack of sufficient scientific evidence to substantiate their
efficacy.Mulligan mobilization techniques are manual therapy techniques that aim to increase
normal joint movement and reduce pain levels by correcting the biomechanical structure of
joint surfaces to provide a pain-free range of motion. A review of the literature reveals no
studies comparing the Mulligan mobilization technique and corticosteroid injections in
rotator cuff tears. The aim of our study is to examine the effects of the Mulligan
mobilization technique and corticosteroid injections on pain, range of motion, functionality
and proprioception in individuals with rotator cuff tears.
Description:
Individuals diagnosed with rotator cuff rupture presenting at Medipol Esenler Hospital will
be included in the study. Participants will be randomly divided into 2 groups. A conventional
treatment program will be applied to individuals in both groups 5 days a week for 3 weeks.
The conventional exercise program will consist of wand exercises, Codman exercises,
stretching exercises for all ranges of motion, and TENS (100Hz, 15 minutes). A corticosteroid
injection will be administered to the shoulder region of the first group prior to treatment.
For the second group, in addition to the conventional treatment program, a mobilization
technique with movement will be applied twice a week, with 10 repetitions. Inclusion
Criteria:
- Being between the ages of 40 and 60
- Not having had any shoulder surgery before
- Having been diagnosed with a rotator cuff lesion
- Not having any orthopedic or cardiac problems that could hinder participation in the
study and evaluation
Exclusion Criteria:
- Having a pathology affecting the shoulder area
- Having had any shoulder surgery
- Individuals who are non-cooperative or have mental problems
- Individuals with neurological, cardiac, and vascular problems
- Individuals who have participated in any physiotherapy program directed towards the
shoulder in the last three months
Evaluation Scales to be Used:
- Visual Analog Scale - VAS
- Joint Range of Motion - Becure extremity ROM
- Joint Position Sense - Becure extremity ROM
- Disability of the Arm, Shoulder and Hand Questionnaire - DASH
Evaluation Methods:
1. Visual Analog Scale (VAS) The Visual Analog Scale is a commonly preferred evaluation
method in the clinic and literature studies for measuring pain intensity. Patients' pain
levels are determined by numbering 0-10. 0 indicates no pain, and 10 represents the most
severe pain experienced.
2. Joint Range of Motion The normal joint range of motion was evaluated with the Becure
Extremity ROM. Becure Extremity ROM is a system that allows for the objective
measurement of joint range of motion by using its camera and sensors to detect reference
points during extremity movements. In the Becure Extremity ROM system, the patient is
expected to stand in front of the camera and perform the movement to be measured. In our
study, the shoulder joint's flexion, extension, abduction, internal and external
rotation ranges of motion were evaluated in degrees with Becure Extremity ROM.
3. Joint Position Sense The joint position sense measurements of the individuals
participating in the study will be evaluated with a goniometer. Individuals will be
asked to lift their shoulder to a certain degree, and then bring it back to the same
angle value with their eyes closed. The angle value formed when eyes are open and closed
will be recorded, and the difference between shoulder angles will be calculated. Joint
position sense will be applied at 30 and 60 degrees of flexion and abduction movements.
4. Disability of the Arm, Shoulder, and Hand Questionnaire (DASH) The DASH, developed as a
result of the collaboration of the American Academy of Orthopedic Surgeons and other
groups, is a scale that evaluates physical restrictions and function in upper extremity
lesions[18]. The DASH questionnaire consists of three subsections. The first part
contains 30 questions; 21 questions evaluate the difficulties encountered in the
patient's daily life functions, 5 questions are about symptoms, and the other 4
questions assess social life, work, sleep, and the individual's self-confidence. The
part with 4 questions (optional Work Module (DASH- FS)) measures the difficulties
encountered in the individual's work life.
