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CompletedNCT06046430Updated Aug 20, 2024

Investigation of Laterality and Sensory Acuity Abilities of Frozen Shoulder Patients

An observational study in Frozen Shoulder and Laterality Defects, sponsored by Harran University. Completed at 1 site in Turkey. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-20.

Sponsored by Harran University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
49
Ages
35 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Frozen Shoulder
  • Laterality Defects

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03

In context

Bursitis

411 studies on the registry are indexed under Bursitis; 112 are open to participants now.

This study's enrollment of 49 is below the median of 58 across 32 observational studies indexed under Bursitis.

Browse Bursitis studies →

Lead sponsor

Harran University is the lead sponsor of 60 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The sample of the study will consist of patients who applied to Harran University Hospital and were diagnosed with frozen shoulder.

Eligibility criteria

Frozen Shoulder Group:

Inclusion Criteria:

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

Exclusion Criteria:

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 :

Inclusion criteria:

No actual shoulder pain or previous history of shoulder complaints including Frozen Shoulder.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
49 participants (actual)
Patient registry
No

Groups and cohorts

  • Frozen Shoulder Group

    The sample of the study will consist of patients who applied to Harran University Hospital and were diagnosed with frozen shoulder.

    Other: Assessment

  • Healthy Group

    Healthy volunteers similar to the patient group in gender and age factors.

    Other: Assessment

Interventions

  • OtherAssessment

    The same assessments will be made to participants in both groups.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

Secondary outcomes

  1. Pain Intensity

    Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.

    Time frame: Baseline

  2. Active Range of Motion (AROM) Assessment

    The shoulder's AROM, including flexion, abduction, internal and external rotation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.

    Time frame: Baseline

  3. Central sensitization

    The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients who have symptoms that may be related to central sensitisation (CS). The CSI consists of two parts. Part A includes 25 questions related to common CSS symptoms. Part B determines if the patient has been diagnosed with certain CSS disorders or related disorders, such as anxiety and depression

    Time frame: Baseline

  4. Pain Catastrophizing

    Pain catastrophizing is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event. As such, the Pain Catastrophizing Scale (PCS) was developed to help quantify an individual's pain experience, asking about how they feel and what they think about when they are in pain. Compared to other ways of measuring pain-related thoughts, this questionnaire is unique in that the individual does not need to be in pain while completing it.

    Time frame: Baseline

  5. Anxiety and Depression

    The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. The depression items tend to focus on the anhedonic symptoms of depression.

    Time frame: Baseline

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Study locations

1 site
  • Harran University
    Şanlıurfa, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06046430
Lead sponsor
Harran University
Responsible party
Zeynal Yasacı (Principal Investigator, Harran University) — Principal investigator
First posted
Sep 21, 2023
Start date
Jan 1, 2024
Primary completion
May 1, 2024
Completion
Aug 15, 2024
Last update
Aug 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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