PainNCT04454632
The Effect of Mirror Therapy in Patients With Frozen Shoulder
A study testing Mirror therapy and Visual feedback in people with Pain and Frozen Shoulder, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study compares mirror therapy and visual feedback treatment with the control group in frozen shoulder patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Frozen Shoulder
- What is being tested?
- Mirror therapy and Visual feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2018to 27 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Lutfi Kirdar City Hospital
Istanbul, Kartal, 34865
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Frozen Shoulder
- Being tested
- Mirror therapy, Visual feedback
- Keywords
- Frozen Shoulder, visual feedback, proprioception, pain insensitivity, shoulder pain
- Medical subject headings
- Pain, Bursitis, Agnosia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapyOther
affected arm stay behind the mirror while exercising
Visual feedbackOther
visual feedback from mirror
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy group | Experimental | 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. Receives: Other: Mirror therapy |
| Visual feedback group | Experimental | 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. Receives: Other: Visual feedback |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline, 6 weeks and 10 weeks
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.
Measured: Change from Baseline, 6 weeks and 10 weeks
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.
Measured: Change from Baseline, 6 weeks and 10 weeks
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.
Measured: Change from Baseline, 6 weeks and 10 weeks
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.
Measured: Change from Baseline, 6 weeks and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start15 Feb 2018
- Primary completion29 May 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TUGBA KURU ÇOLAK, Assoc. Prof., Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454632
- Sponsor's protocol ID
- Dr. Lutfi Kirdar Hospital
- Status last verified
- Jun 2020
- First submitted
- 25 Jun 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30056414Sato 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.
PubMed 20202141
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effectiveness of Mirror Therapy in the Treatment of Patients With Frozen Shoulder: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04454632
- Acronym / sponsor ID
- Dr. Lutfi Kirdar Hospital
- Conditions
- Pain, Frozen Shoulder
- Keywords
- Frozen Shoulder, visual feedback, proprioception, pain insensitivity, shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy group | Experimental | Other: Mirror therapyThe 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. |
| Visual feedback group | Experimental | Other: Visual feedbackThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror therapyaffected arm stay behind the mirror while exercising | Other | Mirror therapy group |
| Visual feedbackvisual feedback from mirror | Other | Visual feedback group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Results publication: PubMed 30056414Baskaya 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 publication: PubMed 20202141Sato 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.
- Mirror therapy in frozen shoulderLink provided by the sponsor.
- visual feedback therapyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUGBA KURU ÇOLAK, Assoc. Prof. study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror therapy and Visual feedback in people with Pain and Frozen Shoulder, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Change from Baseline, 6 weeks and 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04454632, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.