- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04454632
The Effect of Mirror Therapy in Patients With Frozen Shoulder
June 8, 2021 updated by: Marmara University
Examination of the Effectiveness of Mirror Therapy in the Treatment of Patients With Frozen Shoulder: A Prospective Randomized Controlled Study
The aim of this study compares mirror therapy and visual feedback treatment with the control group in frozen shoulder patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Thirty-six individuals divided three groups as mirror therapy, visual feedback, and control groups were included in the study for 15 sessions of treatment.
All individuals received basic treatment as ultrasound, transcutaneous electrical nerve stimulation, cold pack, stretching exercises, glenohumeral range of motion exercises, scapulothoracic exercises.
The mirror group bilateral exercised with an affected arm behind the mirror; visual feedback group bilateral exercised by seeing both arms in the mirror; control group bilateral exercised without a mirror for 10 minutes after every session.
Pain severity was evaluated with the "Visual Analogue Scale (VAS)", ROM and proprioception were measured with a universal goniometer, and functional status was evaluated with "shoulder pain and disability index (SPADI)" and "Modified Constant Score".
Evaluations were made before, day after the treatment and 4 weeks after the treatment by the same researcher.
Data analysis was performed with SPSS.23.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kartal
-
Istanbul, Kartal, Turkey, 34865
- Dr. Lutfi Kirdar City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals who were diagnosed with "Unilateral Frozen Shoulder" by the specialist;
- Normal radiological imaging;
- Aged between 18-75 years old;
- Symptoms persist for 2-12 months.
Exclusion Criteria:
- If patients had following comorbidities: rotator cuff injury, cervical radiculopathy, romatological diseases, neurological diseases, fracture, tumour, congenital deformities, dislocation or sublocation, surgery in the shoulder, uncontrolled hypertension or diabetes mellitus;
- Pregnancy;
- Patients who had previously received physical therapy;
- Patients having problems in the perception of tests and exercises were excluded from this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mirror therapy group
The number of participants in this group is anticipated to be 12.
In addition to basic treatment, the mirror therapy group bilateral exercised with the affected arm behind the mirror for 10 minutes after every session.
Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation.
|
affected arm stay behind the mirror while exercising
|
EXPERIMENTAL: Visual feedback group
The number of participants in this group is anticipated to be 12.
In addition to basic treatment, the visual feedback group bilateral exercised by seeing both arms in the mirror for 10 minutes after every session.
Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation while seeing both arms in the mirror.
|
visual feedback from mirror
|
NO_INTERVENTION: Control group
The number of participants in this group is anticipated to be 12.
In addition to basic treatment, the control group bilateral exercised without a mirror for 10 minutes after every session.
Participants in this group perform three exercises as glenohumeral flexion, abduction, and rotation while seeing both arms in the mirror.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: Change from Baseline, 6 weeks and 10 weeks
|
Pain intensity was obtained using a Visual Analog Scale (VAS).
VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "severe pain" on the right side.
The patient was asked to mark the line point that represented his or her worst pain in the past week during daily rutine.
|
Change from Baseline, 6 weeks and 10 weeks
|
Range of Motion (ROM)
Time Frame: Change from Baseline, 6 weeks and 10 weeks
|
Range of motion is the measurement of the amount of movement around a joint as a flexion, abduction, external rotation and internal rotation (degree).
Measurement performed with universal goniometer.
|
Change from Baseline, 6 weeks and 10 weeks
|
Proprioception
Time Frame: Change from Baseline, 6 weeks and 10 weeks
|
Proprioception is the sense of self-movement and body position.
A joint position error test (JPET) was used for proprioception measurement.
JPET is a deviation of the ability to reposition the joint to the target position which fifty percent of active flexion ROM.
|
Change from Baseline, 6 weeks and 10 weeks
|
Shoulder Pain and Disability Index (SPADI)
Time Frame: Change from Baseline, 6 weeks and 10 weeks
|
The shoulder pain and disability index is a self-administered questionnaire that consists of two dimensions, one for pain and the other one for functional activities on the shoulder.
The total score is defining as a percent.
0 for best score 100 for worst score.
|
Change from Baseline, 6 weeks and 10 weeks
|
Modified Constant-Murley Score (CMS)
Time Frame: Change from Baseline, 6 weeks and 10 weeks
|
The modified Constant-Murley score is a questionnaire for shoulder injuries that consists of four dimensions, pain, activities of daily living, range of movement, and power.
Pain and activities of daily living are considered subjective scores therefore the range of movement and power considered objective score.
100 for best score 0 for worst score.
|
Change from Baseline, 6 weeks and 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Baskaya MC, Ercalik C, Karatas Kir O, Ercalik T, Tuncer T. The efficacy of mirror therapy in patients with adhesive capsulitis: A randomized, prospective, controlled study. J Back Musculoskelet Rehabil. 2018;31(6):1177-1182. doi: 10.3233/BMR-171050.
- Sato K, Fukumori S, Matsusaki T, Maruo T, Ishikawa S, Nishie H, Takata K, Mizuhara H, Mizobuchi S, Nakatsuka H, Matsumi M, Gofuku A, Yokoyama M, Morita K. Nonimmersive virtual reality mirror visual feedback therapy and its application for the treatment of complex regional pain syndrome: an open-label pilot study. Pain Med. 2010 Apr;11(4):622-9. doi: 10.1111/j.1526-4637.2010.00819.x. Epub 2010 Mar 1.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 15, 2018
Primary Completion (ACTUAL)
May 29, 2019
Study Completion (ACTUAL)
June 27, 2019
Study Registration Dates
First Submitted
June 25, 2020
First Submitted That Met QC Criteria
June 30, 2020
First Posted (ACTUAL)
July 1, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 10, 2021
Last Update Submitted That Met QC Criteria
June 8, 2021
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dr. Lutfi Kirdar Hospital
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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