NCT04454632

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

June 25, 2020

Last Update Submit

June 8, 2021

Conditions

Keywords

Frozen Shouldervisual feedbackproprioceptionpain insensitivityshoulder pain

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

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.

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.

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.

Interventions

affected arm stay behind the mirror while exercising

Mirror therapy group

visual feedback from mirror

Visual feedback group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Lutfi Kirdar City Hospital

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

PainBursitisAgnosiaShoulder Pain

Interventions

Mirror Movement TherapyFeedback, Sensory

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal DiseasesPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesArthralgia

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeuticsBiofeedback, PsychologyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalFeedback, PhysiologicalHomeostasisPhysiological Phenomena

Study Officials

  • TUGBA KURU ÇOLAK, Assoc. Prof.

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2020

First Posted

July 1, 2020

Study Start

February 15, 2018

Primary Completion

May 29, 2019

Study Completion

June 27, 2019

Last Updated

June 10, 2021

Record last verified: 2020-06

Locations