Investigation of Laterality and Sensory Acuity Abilities of Frozen Shoulder Patients
1 other identifier
observational
49
1 country
1
Brief Summary
The brain contains the body representation necessary for normal functioning, including goal-directed movements and behaviors. Body representation involves integrated sensory input and ideas about one's body. Both executed and imagined movements depend on the representation of the body in the cortical area. Laterilization is one of the motor imagery methods that requires activation of proprioceptive, somatosensory and premotor regions and enables the determination of pain-induced cortical changes. Another method to determine pain-related somatosensory changes is the two-point discrimination test. It is suggested that laterization and sensory acuity responses may change due to long-term pain and stiffness experienced in people with frozen shoulders. Therefore, the aim of this study is to investigate the laterization and sensory acuity abilities of patients with frozen shoulder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2024
CompletedAugust 20, 2024
August 1, 2024
4 months
September 14, 2023
August 19, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Right-Left Discrimination
Right-Left Discrimination will be assessed with Recognise™ application. It tests the patients' ability to quickly and accurately recognise an image of a body area as either left or right ('Left/Right Discrimination'). The test will be repeated three times and average values will be recorded.
Baseline
Acuity
Two point discrimination is the ability to discern that two nearby objects touching the skin are truly two distinct points, not one.In clinical settings, two-point discrimination is a widely used technique for assessing tactile perception. It relies on the ability and/or willingness of the patient to subjectively report what they are feeling and should be completed with the patient's eyes closed. Aesthesiometer is the instrument used to determine two point discrimination values.
Baseline
Secondary Outcomes (5)
Pain Intensity
Baseline
Active Range of Motion (AROM) Assessment
Baseline
Central sensitization
Baseline
Pain Catastrophizing
Baseline
Anxiety and Depression
Baseline
Study Arms (2)
Frozen Shoulder Group
The sample of the study will consist of patients who applied to Harran University Hospital and were diagnosed with frozen shoulder.
Healthy Group
Healthy volunteers similar to the patient group in gender and age factors.
Interventions
The same assessments will be made to participants in both groups.
Eligibility Criteria
The sample of the study will consist of patients who applied to Harran University Hospital and were diagnosed with frozen shoulder.
You may qualify if:
- Patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear; Patients with ability to follow simple orders; iii) Patients with ability to sign to provide informed consent
You may not qualify if:
- Normal passive ROM External ROM \< 30 To have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint Pain \< 3 according to the numbered pain assessment scale
- Healthy group :
- No actual shoulder pain or previous history of shoulder complaints including Frozen Shoulder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harran University
Sanliurfa, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 14, 2023
First Posted
September 21, 2023
Study Start
January 1, 2024
Primary Completion
May 1, 2024
Study Completion
August 15, 2024
Last Updated
August 20, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share