Two Different Exercise Training in Frozen Shoulder Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the effects of two different exercise programs in patients with frozen shoulders.

Detailed Description
-----------------
After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double-blind manner in a 1:1 (participant and investigator) to graded motor imagery or exercise group.

Official Title
-----------------
Comparison of the Effectiveness of Two Different Exercise Training in Frozen Shoulder Treatment

Conditions
-----------------
Adhesive Capsulitis

Intervention / Treatment
-----------------
* Other: Graded Motor Imagery
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged >60 years Patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear; Patients with ability to follow simple orders; iii) Patients with ability to sign to provide informed consent Exclusion Criteria: Normal passive ROM External ROM < 30 To have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint Pain < 3 according to the numbered pain assessment scale

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Graded Motor İmagery<br>Graded Motor İmagery (GMI) group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, traditional exercises and home exercises. | Other: Graded Motor Imagery<br>* Graded Motor Imagery program will be performed two times a week for six consecutive weeks and will include the following three steps: laterality training, imagined movements, and mirror therapy. Right-left discrimination training (lateralization training) Imagination of hand movements (motor imagery): Mirror therapy Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.<br>|
| Active Comparator: Exercise<br>Exercise group will receive training involves mobilizations, stretching, specific exercises for the frozen shoulder. | Other: Exercise<br>* Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline The Shoulder Pain and Disability Index at 6th and 8th week | The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. | Baseline,6th week and 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline NPRS at 6th and 8th week | The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain. | Baseline,6th week and 8th week | 
| Change from baseline range of motion at 6th and 8th week | Range of motion is the capability of a joint to go through its complete spectrum of movements. | Baseline,6th week and 8th week | 
| Change from baseline QuickDASH at 6th and 8th week | The purpose of the QuickDASH is to use 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. | Baseline,6th week and 8th week | 
| Change from baseline two-point discrimination at 6th and 8th week | The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception. | Baseline,6th week and 8th week | 
| Change from Pain Catastrophizing Scale at 6th and 8th week | The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. | Baseline,6th week and 8th week | 
| Change from SF-12 at 6th and 8th week | The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. | Baseline,6th week and 8th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
frozen shoulder, exercise, graded motor imagery