Clinical trial NCT05933382: Investigation of the Effects of Mulligan Mobilization and Corticosteroid Injection in Rotator Cuff Lesions
Official title: Investigation of the Effects of Mobilization With Movement Technique and Corticosteroid Injection on Pain, Functionality, and Proprioception in Rotator Cuff Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: Mobilization with movement
Rotator cuff
Corticosteroid
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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:

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

Primary outcomes:
measure: Visuel Analogue Scale (VAS)
timeFrame: 5 minutes
measure: Normal range of motion and proprioception
timeFrame: 10 minutes
Secondary outcomes:
measure: Functionality
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Merve YILMAZ MENEK, PhD
role: STUDY_DIRECTOR
References: