NCT06046430

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

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

September 14, 2023

Last Update Submit

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.

Other: Assessment

Healthy Group

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

Other: Assessment

Interventions

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

Frozen Shoulder GroupHealthy Group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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)

Location

MeSH Terms

Conditions

Bursitis

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

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

Locations