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The Effect of Mirror Therapy in Patients With Frozen Shoulder

Primary Purpose

Pain, Frozen Shoulder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mirror therapy
Visual feedback
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Frozen Shoulder, visual feedback, proprioception, pain insensitivity, shoulder pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Lutfi Kirdar City Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Mirror therapy group

Visual feedback group

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 25, 2020
Last Updated
June 8, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04454632
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
May 29, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Frozen Shoulder
Keywords
Frozen Shoulder, visual feedback, proprioception, pain insensitivity, shoulder pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Visual feedback group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mirror therapy
Intervention Description
affected arm stay behind the mirror while exercising
Intervention Type
Other
Intervention Name(s)
Visual feedback
Intervention Description
visual feedback from mirror
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
Change from Baseline, 6 weeks and 10 weeks
Title
Range of Motion (ROM)
Description
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.
Time Frame
Change from Baseline, 6 weeks and 10 weeks
Title
Proprioception
Description
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.
Time Frame
Change from Baseline, 6 weeks and 10 weeks
Title
Shoulder Pain and Disability Index (SPADI)
Description
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.
Time Frame
Change from Baseline, 6 weeks and 10 weeks
Title
Modified Constant-Murley Score (CMS)
Description
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.
Time Frame
Change from Baseline, 6 weeks and 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TUGBA KURU ÇOLAK, Assoc. Prof.
Organizational Affiliation
Marmara University
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Lutfi Kirdar City Hospital
City
Istanbul
State/Province
Kartal
ZIP/Postal Code
34865
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
30056414
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.
Results Reference
result
PubMed Identifier
20202141
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/30056414/
Description
Mirror therapy in frozen shoulder
URL
https://pubmed.ncbi.nlm.nih.gov/20202141/
Description
visual feedback therapy

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The Effect of Mirror Therapy in Patients With Frozen Shoulder

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