Clinical trial NCT04454632: The Effect of Mirror Therapy in Patients With Frozen Shoulder
Official title: Examination of the Effectiveness of Mirror Therapy in the Treatment of Patients With Frozen Shoulder: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Frozen Shoulder
Keywords: Frozen Shoulder
visual feedback
proprioception
pain insensitivity
shoulder pain
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from Baseline, 6 weeks and 10 weeks
measure: Range of Motion (ROM)
timeFrame: Change from Baseline, 6 weeks and 10 weeks
measure: Proprioception
timeFrame: Change from Baseline, 6 weeks and 10 weeks
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from Baseline, 6 weeks and 10 weeks
measure: Modified Constant-Murley Score (CMS)
timeFrame: Change from Baseline, 6 weeks and 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dr. Lutfi Kirdar City Hospital
state: Kartal
Study officials:
affiliation: Marmara University
name: TUGBA KURU ÇOLAK, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
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 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.