Frozen ShoulderNCT06046430
Investigation of Laterality and Sensory Acuity Abilities of Frozen Shoulder Patients
An observational study of Frozen Shoulder and Laterality Defects, run by Harran University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Frozen Shoulder, Laterality Defects
- What is being tested?
- Assessment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 15 Aug 2024
- Phase
- Observational
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample of the study will consist of patients who applied to Harran University Hospital and were diagnosed with frozen shoulder.
Who may be able to join
- 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
- No actual shoulder pain or previous history of shoulder complaints including Frozen Shoulder.
Who cannot join
- 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 :
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Frozen Shoulder, Laterality Defects
- Being tested
- Assessment
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
The same assessments will be made to participants in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Frozen Shoulder Group | The sample of the study will consist of patients who applied to Harran University Hospital and were diagnosed with frozen shoulder. Receives: Other: Assessment | |
| Healthy Group | Healthy volunteers similar to the patient group in gender and age factors. Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Secondary outcomes (5)
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.
Measured: Baseline
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.
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynal Yasacı, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046430
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2024
- First submitted
- 14 Sep 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Laterality and Sensory Acuity Abilities of Frozen Shoulder Patients
- ClinicalTrials.gov ID
- NCT06046430
- Acronym / sponsor ID
- 1
- Conditions
- Frozen Shoulder, Laterality Defects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 21 Sep 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frozen Shoulder Group | – | Other: AssessmentThe sample of the study will consist of patients who applied to Harran University Hospital and were diagnosed with frozen shoulder. |
| Healthy Group | – | Other: AssessmentHealthy volunteers similar to the patient group in gender and age factors. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample of the study will consist of patients who applied to Harran University Hospital and were diagnosed with frozen shoulder.
Key inclusion criteria (2 listed)
- 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
- No actual shoulder pain or previous history of shoulder complaints including Frozen Shoulder.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| AssessmentThe same assessments will be made to participants in both groups. | Other | Frozen Shoulder Group, Healthy Group |
Primary outcome
Right-Left Discrimination
Time frame: Baseline
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.
Acuity
Time frame: Baseline
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.
5 secondary outcomes
Pain Intensity
Time frame: Baseline
Active Range of Motion (AROM) Assessment
Time frame: Baseline
Central sensitization
Time frame: Baseline
Pain Catastrophizing
Time frame: Baseline
Anxiety and Depression
Time frame: Baseline
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 20 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frozen Shoulder and Laterality Defects, run by Harran 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 2 inclusion and 2 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 20 Aug 2024. 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?
Right-Left Discrimination (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2024.