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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04454632
Other study ID # Dr. Lutfi Kirdar Hospital
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2018
Est. completion date June 27, 2019

Study information

Verified date June 2020
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study compares mirror therapy and visual feedback treatment with the control group in frozen shoulder patients.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 27, 2019
Est. primary completion date May 29, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Mirror therapy
affected arm stay behind the mirror while exercising
Visual feedback
visual feedback from mirror

Locations

Country Name City State
Turkey Dr. Lutfi Kirdar City Hospital Istanbul Kartal

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Baskaya MÇ, Erçalik C, Karatas Kir Ö, Erçalik 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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) 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
Primary Range of Motion (ROM) 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
Primary Proprioception 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
Primary Shoulder Pain and Disability Index (SPADI) 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
Primary Modified Constant-Murley Score (CMS) 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
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