Back to resultsTwo Different Exercise Training in Frozen Shoulder Treatment
Primary Purpose
Adhesive Capsulitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Graded Motor Imagery
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring frozen shoulder, exercise, graded motor imagery
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
Sites / Locations
- İstanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Graded Motor İmagery
Exercise
Arm Description
Graded Motor İmagery (GMI) group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, traditional exercises and home exercises.
Exercise group will receive training involves mobilizations, stretching, specific exercises for the frozen shoulder.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05213351
Brief Title
Two Different Exercise Training in Frozen Shoulder Treatment
Official Title
Comparison of the Effectiveness of Two Different Exercise Training in Frozen Shoulder Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
July 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
frozen shoulder, exercise, graded motor imagery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Graded Motor İmagery
Arm Type
Experimental
Arm Description
Graded Motor İmagery (GMI) group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, traditional exercises and home exercises.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Exercise group will receive training involves mobilizations, stretching, specific exercises for the frozen shoulder.
Intervention Type
Other
Intervention Name(s)
Graded Motor Imagery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.
Primary Outcome Measure Information:
Title
Change from baseline The Shoulder Pain and Disability Index at 6th and 8th week
Description
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.
Time Frame
Baseline,6th week and 8th week
Secondary Outcome Measure Information:
Title
Change from baseline NPRS at 6th and 8th week
Description
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.
Time Frame
Baseline,6th week and 8th week
Title
Change from baseline range of motion at 6th and 8th week
Description
Range of motion is the capability of a joint to go through its complete spectrum of movements.
Time Frame
Baseline,6th week and 8th week
Title
Change from baseline QuickDASH at 6th and 8th week
Description
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.
Time Frame
Baseline,6th week and 8th week
Title
Change from baseline two-point discrimination at 6th and 8th week
Description
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.
Time Frame
Baseline,6th week and 8th week
Title
Change from Pain Catastrophizing Scale at 6th and 8th week
Description
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.
Time Frame
Baseline,6th week and 8th week
Title
Change from SF-12 at 6th and 8th week
Description
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.
Time Frame
Baseline,6th week and 8th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derya Çelik
Organizational Affiliation
Istanbul University
Official's Role
Study Director
Facility Information:
Facility Name
İstanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Two Different Exercise Training in Frozen Shoulder Treatment
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