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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Mirror therapy
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.
Other: Visual feedback
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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