Frozen ShoulderNCT06391567
Balance in People With Frozen Shoulder
An observational study of Frozen Shoulder, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the balance characteristics of patients with Frozen Shoulder. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Frozen Shoulder
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2023to 16 Apr 2024
- How long will I take part?
- 1 Day
- 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 40 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients admitted to the Physical Medicine and Rehabilitation Outpatient Clinic with complaints of shoulder pain were examined by a physiatrist. Patients who were diagnosed with Frozen Shoulder by physical examination, who met the inclusion criteria, and who agreed to participate in the study were included in the study. The control group consisted of hospital and university staff. The control group was also assessed by the same physiatrist and confirmed by the country's health database as having no chronic disease affecting balance.
Who may be able to join
- Volunteers aged 40-65 years,
- Diagnosed with unilateral Frozen Shoulder, Frozen Shoulder stage 2-3,
- Pain lasting more than 3 months,
- No mental or cognitive impairment
- At least 25% movement limitation in at least 2 movement planes and
- Able to cooperate.
Who cannot join
- Who had a neurological, rheumatic, cardiac and active malignant diseases
- Who had a history of surgery, trauma, and fracture
- Who had comorbid conditions that would affect balance
- The control group consisted of healthy subjects who were not diagnosed with Frozen Shoulder and did not have a chronic disease that would affect balance between the ages of 40-65.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Balance Characteristics in People With Frozen Shoulders
The aim of this study was to investigate the balance characteristics of patients with Frozen Shoulder.
- Conditions
- Frozen Shoulder
- Being tested
- There was no intervention in this study.
- Keywords
- Adhesive Capsulitis, Balance, Pain
- Medical subject headings
- Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There was no intervention in this study.Other
There was no intervention in this study.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | The control group consisted of healthy subjects who were not diagnosed with Frozen Shoulder and did not have a chronic disease that would affect balance between the ages of 40-65. Receives: Other: There was no intervention in this study. | |
| Patient Group | Patients who were diagnosed with Frozen Shoulder by physical examination, met the inclusion criteria, and agreed to participate in the study were selected for the patient group. Receives: Other: There was no intervention in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic Form
Sociodemographic information of the patients included in the study, such as age, gender, height, weight, BMI, educational status, dominant side, comorbid status, and clinical information such as affected side, pain intensity, and pain duration were collected in a case report form by face-to-face interview
Measured: 8 week
Balance Function
Balance function was measured with the Timed Up and Go Test (TUG). The TUG is a short, simple, and reliable test used to assess balance. It shows that people who complete the test in less than 20 seconds are independent in transfers, while people who complete the test in 30 seconds or more are more dependent in activities of daily living.
Measured: 8 week
Static and Dynamic Postural Balance
Biodex Balance System was used for objective assessment of static and dynamic postural balance. A high balance score indicates poor balance performance.
Measured: 8 week
Pain Intensity
The pain intensity of the patients was measured using the Visual Analogue Scale. The pain intensity score ranges from 0 to 10. An increase in the score indicates an increase in pain; a decrease in the score indicates a decrease in pain.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start10 Oct 2023
- Primary completion10 Apr 2024
- Study completion16 Apr 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.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- 86 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atahan TURHAN, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391567
- Sponsor's protocol ID
- KAEU-T.ATAHAN-002
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Balance Characteristics in People With Frozen Shoulders
- ClinicalTrials.gov ID
- NCT06391567
- Acronym / sponsor ID
- KAEU-T.ATAHAN-002
- Conditions
- Frozen Shoulder
- Keywords
- Adhesive Capsulitis, Balance, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 30 Apr 2024 (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 aim of this study was to investigate the balance characteristics of patients with Frozen Shoulder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: There was no intervention in this study.The control group consisted of healthy subjects who were not diagnosed with Frozen Shoulder and did not have a chronic disease that would affect balance between the ages of 40-65. |
| Patient Group | – | Other: There was no intervention in this study.Patients who were diagnosed with Frozen Shoulder by physical examination, met the inclusion criteria, and agreed to participate in the study were selected for the patient group. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Physical Medicine and Rehabilitation Outpatient Clinic with complaints of shoulder pain were examined by a physiatrist. Patients who were diagnosed with Frozen Shoulder by physical examination, who met the inclusion criteria, and who agreed to participate in the study were included in the study. The control group consisted of hospital and university staff. The control group was also assessed by the same physiatrist and confirmed by the country's health database as having no chronic disease affecting balance.
Key inclusion criteria (6 listed)
- Volunteers aged 40-65 years,
- Diagnosed with unilateral Frozen Shoulder, Frozen Shoulder stage 2-3,
- Pain lasting more than 3 months,
- No mental or cognitive impairment
- At least 25% movement limitation in at least 2 movement planes and
Key exclusion criteria (4 listed)
- Who had a neurological, rheumatic, cardiac and active malignant diseases
- Who had a history of surgery, trauma, and fracture
- Who had comorbid conditions that would affect balance
- The control group consisted of healthy subjects who were not diagnosed with Frozen Shoulder and did not have a chronic disease that would affect balance between the ages of 40-65.
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 |
|---|---|---|
| There was no intervention in this study.There was no intervention in this study. | Other | Control Group, Patient Group |
Primary outcome
Sociodemographic Form
Time frame: 8 week
Sociodemographic information of the patients included in the study, such as age, gender, height, weight, BMI, educational status, dominant side, comorbid status, and clinical information such as affected side, pain intensity, and pain duration were collected in a case report form by face-to-face interview
Balance Function
Time frame: 8 week
Balance function was measured with the Timed Up and Go Test (TUG). The TUG is a short, simple, and reliable test used to assess balance. It shows that people who complete the test in less than 20 seconds are independent in transfers, while people who complete the test in 30 seconds or more are more dependent in activities of daily living.
Static and Dynamic Postural Balance
Time frame: 8 week
Biodex Balance System was used for objective assessment of static and dynamic postural balance. A high balance score indicates poor balance performance.
Pain Intensity
Time frame: 8 week
The pain intensity of the patients was measured using the Visual Analogue Scale. The pain intensity score ranges from 0 to 10. An increase in the score indicates an increase in pain; a decrease in the score indicates a decrease in pain.
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 30 Apr 2024.
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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, run by Kirsehir Ahi Evran Universitesi 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 6 inclusion and 4 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 30 Apr 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?
Sociodemographic Form (time frame: 8 week). The study lists 4 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 30 Apr 2024.