Shoulder InjuriesNCT05828706
The Effects of Pain and Disability Resulting From Shoulder Pathologies On Balance and Mobility
An observational study of Shoulder Injuries, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Among the musculoskeletal pathologies, shoulder pain is the most common symptom after back and neck pain (1, 2). One out of every three adults experiences shoulder pain and limitation in shoulder movements, which affects the functionality of the patients and leads to disability. Read more about this study
- Who is it for?
- Ages 41 to 74 years
- Conditions the study is for
- Shoulder Injuries
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 30 May 2023
- How long will I take part?
- 1 Month
- 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 41 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our study was carried out by Prof. Dr. Bezmialem Vakif University Faculty of Medicine, Department of Physical Medicine and Rehabilitation. Dr. It is planned to include patients referred by Teoman Aydın. In our study, post-hoc power analysis was performed and it was determined that 36 individuals were needed to achieve 95% power with an effect size of r:0.50. Considering the possibility of cases dropping out of the study, it is planned to include 40 individuals. Sociodemographic information form, Shoulder Pain and Disability Index (SPADI), One-leg standing test, 5 sit and stand test, TINetti balance and walking test will be evaluated for the included patients.
Who may be able to join
- Having a pathology related to the upper extremity shoulder such as Impingement, Rotator cuff tear or repair, Adhesive capsulitis (frozen shoulder),
- Able to communicate
- Individuals between the ages of 40-65 who agreed to participate in the study
Who cannot join
- Having vision and hearing problems
- Having other accompanying neurological, psychiatric and/or orthopedic problems other than shoulder pathologies
- Having a pregnancy status
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Bezmialem Vakif University Faculty of Medicine, Department of Physical Medicine and Rehabilitation.
Istanbul, 347093
About this study
Among the musculoskeletal pathologies, shoulder pain is the most common symptom after back and neck pain (1, 2). One out of every three adults experiences shoulder pain and limitation in shoulder movements, which affects the functionality of the patients and leads to disability. (2) Impairment of one or more sensory inputs coming from the visual, somatosensory or afferent pathways from the vestibular system (3-4) causes deterioration of balance control and falls (4-5). Since pain affects the somatosensory system, it causes a decrease in balance ability. This study will be conducted to examine the effect of pain and functionality on balance in shoulder pathologies. Our study included pathologies such as impingement, rotator cuff syndrome, frozen shoulder, fracture between November 1, 2022 and January 1, 2023; A total of 40 patients, 18 females and 12 males, between the ages of 41-74 (56.30±9.25) will be included. Sociodemographic information form, Shoulder Pain and Disability Index (SPADI), One-leg standing test, 5 sit and stand test, TINetti balance and walking test will be evaluated for the included patients. SPSS Version 21.0 program was used for statistical analysis. With Pearson Correlation analysis, it will be evaluated whether the data are related or not.
Read the detailed description
Upper extremity pathologies are musculoskeletal problems that are common in the community, resulting in loss of work force and negative continuation of recreational activities (1,2). Among the pathologies of the musculoskeletal system, shoulder pain is the most common symptom after back and neck pain (3, 4). One out of every three adults experiences shoulder pain and limitation in shoulder movements, which affects the functionality of the patients and leads to disability (4). Among these common problems, there are many diseases such as rotator cuff injuries, adhesive capsulitis, acromioclavicular joint degenerations, calcific tendinitis and instability (5). Impairment of one or more sensory inputs coming from the visual, somatosensory or afferent pathways from the vestibular system (6-7) causes deterioration of balance control and falls (7-8). Since pain affects the somatosensory system, it causes a decrease in balance ability. In addition, pain-induced balance control and muscle inhibition pathways share some pathways in the central nervous system (9 ,10). Therefore, muscle inhibition mechanisms caused by pain may negatively affect balance ability (10,11). It has been proven that patients with shoulder pain have deficiencies in shoulder proprioception as well as trunk and lower extremity coordination (10,12). Problem-free and painless upper extremity movements are mostly related to the stability of the trunk and this is closely related to the stability of the lower extremities and balance control. Any deficiency in trunk and lower extremity stability is largely tolerated by compensating the structures around the upper extremity by increasing speed and power, and this situation paves the way for upper extremity pathologies. It remains unclear whether the lack of balance is a cause or a consequence of injury in individuals with shoulder problems (13). Myers et al. reported that proprioception and coordination deficiencies greatly affect shoulder problems, therefore somatosensory deficiencies in the lower extremity and trunk may cause problems in the upper extremity region (14). Other known factors affecting balance, apart from proprioception and coordination, are attention (15,16), age (17,18), gender and body mass index (BMI) (19,20). Decreased balance can lead to limitation of movement, falls and injuries (21). This situation may also require rehabilitation of balance problems caused by upper extremity pathologies. There is very little published research investigating the relationship between different levels of shoulder pain, balance ability, risk of falling, and fear of falling, covering all age groups diagnosed with musculoskeletal shoulder problems. Although it has been shown that the balance of patients with shoulder pain is adversely affected, it is not clear how pain level and disability affect balance parameters. Therefore, in this study, it was aimed to investigate the relationship between pain severity, functionality and balance in shoulder pathologies,
- Conditions
- Shoulder Injuries
- Keywords
- balance, shoulder pain, mobility, functionality
- Medical subject headings
- Shoulder Injuries, Shoulder Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Shoulder Pain and Functionality (SPADI)
SPADI includes 5 questions about pain and 8 questions about disability, and patients are asked to answer these questions on a numerical scale (22). The score is calculated for pain and disability separately and together. While calculating the score, the sum of the points given to the questions in each section is divided by the maximum score that can be obtained from that section and multiplied by 100. Similarly, in the total score, the total score of all questions is divided by 130 and multiplied by 100. Thus, the scores obtained as a percentage range from 0 to 100.
Measured: 10 minutes
One Leg Stance Test
The one-leg stance test is a test that measures the time of standing on the right and left extremities of the patient and evaluates the static balance. Evaluation is made by recording the time from the moment the patient starts to stand on one leg to the first moment when postural stability is impaired (25). It gives an idea about an individual's risk of falling. If he can stand on one leg for 30 seconds, it can be said that the test is over. If the cut-off value is <10 seconds, it means "unbalance", and if it is <5 seconds, it means "there is a risk of falling" (26).
Measured: 10 minutes
5 Repetition Sit and Stand Test
It is a performance test that evaluates the functional strength of the lower extremity, transitional movements, fall risk, and dynamic balance by recording the performance of individuals sitting and standing on a chair 5 times in series (27). Whitney et al. Developed by The patient is asked to quickly stand up and sit down from the standard chair in which he sits with his arms crossed over his shoulders and his back leaning against the chair (28). Norm times according to age are '60-69' 11.4 seconds, '70-79' 12.6 seconds, and '80-89' 14.8 seconds. The periods indicating the presence of risk of falling are 'Old >12 sec. (If >15 repetitive), Vestibular disease >15 sec., Parkinson's >16 sec' (29).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Apr 2023
- Primary completion26 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, Guzin Kaya Aytutuldu, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828706
- Sponsor's protocol ID
- Biruni Univ
- Status last verified
- Jun 2023
- First submitted
- 12 Apr 2023
- Last updated
- 6 Jun 2023
- 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 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pain and Disability Resulting From Shoulder Pathologies On Balance and Mobility
- ClinicalTrials.gov ID
- NCT05828706
- Acronym / sponsor ID
- Biruni Univ
- Conditions
- Shoulder Injuries
- Keywords
- balance, shoulder pain, mobility, functionality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 25 Apr 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.
Among the musculoskeletal pathologies, shoulder pain is the most common symptom after back and neck pain (1, 2). One out of every three adults experiences shoulder pain and limitation in shoulder movements, which affects the functionality of the patients and leads to disability. (2) Impairment of one or more sensory inputs coming from the visual, somatosensory or afferent pathways from the vestibular system (3-4) causes deterioration of balance control and falls (4-5). Since pain affects the somatosensory system, it causes a decrease in balance ability. This study will be conducted to examine the effect of pain and functionality on balance in shoulder pathologies. Our study included pathologies such as impingement, rotator cuff syndrome, frozen shoulder, fracture between November 1, 2022 and January 1, 2023; A total of 40 patients, 18 females and 12 males, between the ages of 41-74 (56.30±9.25) will be included. Sociodemographic information form, Shoulder Pain and Disability Index (SPADI), One-leg standing test, 5 sit and stand test, TINetti balance and walking test will be evaluated for the included patients. SPSS Version 21.0 program was used for statistical analysis. With Pearson Correlation analysis, it will be evaluated whether the data are related or not.
Detailed description
Upper extremity pathologies are musculoskeletal problems that are common in the community, resulting in loss of work force and negative continuation of recreational activities (1,2). Among the pathologies of the musculoskeletal system, shoulder pain is the most common symptom after back and neck pain (3, 4). One out of every three adults experiences shoulder pain and limitation in shoulder movements, which affects the functionality of the patients and leads to disability (4). Among these common problems, there are many diseases such as rotator cuff injuries, adhesive capsulitis, acromioclavicular joint degenerations, calcific tendinitis and instability (5). Impairment of one or more sensory inputs coming from the visual, somatosensory or afferent pathways from the vestibular system (6-7) causes deterioration of balance control and falls (7-8). Since pain affects the somatosensory system, it causes a decrease in balance ability. In addition, pain-induced balance control and muscle inhibition pathways share some pathways in the central nervous system (9 ,10). Therefore, muscle inhibition mechanisms caused by pain may negatively affect balance ability (10,11). It has been proven that patients with shoulder pain have deficiencies in shoulder proprioception as well as trunk and lower extremity coordination (10,12). Problem-free and painless upper extremity movements are mostly related to the stability of the trunk and this is closely related to the stability of the lower extremities and balance control. Any deficiency in trunk and lower extremity stability is largely tolerated by compensating the structures around the upper extremity by increasing speed and power, and this situation paves the way for upper extremity pathologies. It remains unclear whether the lack of balance is a cause or a consequence of injury in individuals with shoulder problems (13). Myers et al. reported that proprioception and coordination deficiencies greatly affect shoulder problems, therefore somatosensory deficiencies in the lower extremity and trunk may cause problems in the upper extremity region (14). Other known factors affecting balance, apart from proprioception and coordination, are attention (15,16), age (17,18), gender and body mass index (BMI) (19,20). Decreased balance can lead to limitation of movement, falls and injuries (21). This situation may also require rehabilitation of balance problems caused by upper extremity pathologies. There is very little published research investigating the relationship between different levels of shoulder pain, balance ability, risk of falling, and fear of falling, covering all age groups diagnosed with musculoskeletal shoulder problems. Although it has been shown that the balance of patients with shoulder pain is adversely affected, it is not clear how pain level and disability affect balance parameters. Therefore, in this study, it was aimed to investigate the relationship between pain severity, functionality and balance in shoulder pathologies,
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 41 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study was carried out by Prof. Dr. Bezmialem Vakif University Faculty of Medicine, Department of Physical Medicine and Rehabilitation. Dr. It is planned to include patients referred by Teoman Aydın. In our study, post-hoc power analysis was performed and it was determined that 36 individuals were needed to achieve 95% power with an effect size of r:0.50. Considering the possibility of cases dropping out of the study, it is planned to include 40 individuals. Sociodemographic information form, Shoulder Pain and Disability Index (SPADI), One-leg standing test, 5 sit and stand test, TINetti balance and walking test will be evaluated for the included patients.
Key inclusion criteria (3 listed)
- Having a pathology related to the upper extremity shoulder such as Impingement, Rotator cuff tear or repair, Adhesive capsulitis (frozen shoulder),
- Able to communicate
- Individuals between the ages of 40-65 who agreed to participate in the study
Key exclusion criteria (3 listed)
- Having vision and hearing problems
- Having other accompanying neurological, psychiatric and/or orthopedic problems other than shoulder pathologies
- Having a pregnancy status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of Shoulder Pain and Functionality (SPADI)
Time frame: 10 minutes
SPADI includes 5 questions about pain and 8 questions about disability, and patients are asked to answer these questions on a numerical scale (22). The score is calculated for pain and disability separately and together. While calculating the score, the sum of the points given to the questions in each section is divided by the maximum score that can be obtained from that section and multiplied by 100. Similarly, in the total score, the total score of all questions is divided by 130 and multiplied by 100. Thus, the scores obtained as a percentage range from 0 to 100.
One Leg Stance Test
Time frame: 10 minutes
The one-leg stance test is a test that measures the time of standing on the right and left extremities of the patient and evaluates the static balance. Evaluation is made by recording the time from the moment the patient starts to stand on one leg to the first moment when postural stability is impaired (25). It gives an idea about an individual's risk of falling. If he can stand on one leg for 30 seconds, it can be said that the test is over. If the cut-off value is <10 seconds, it means "unbalance", and if it is <5 seconds, it means "there is a risk of falling" (26).
5 Repetition Sit and Stand Test
Time frame: 10 minutes
It is a performance test that evaluates the functional strength of the lower extremity, transitional movements, fall risk, and dynamic balance by recording the performance of individuals sitting and standing on a chair 5 times in series (27). Whitney et al. Developed by The patient is asked to quickly stand up and sit down from the standard chair in which he sits with his arms crossed over his shoulders and his back leaning against the chair (28). Norm times according to age are '60-69' 11.4 seconds, '70-79' 12.6 seconds, and '80-89' 14.8 seconds. The periods indicating the presence of risk of falling are 'Old >12 sec. (If >15 repetitive), Vestibular disease >15 sec., Parkinson's >16 sec' (29).
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 6 Jun 2023.
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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 Shoulder Injuries, run by Biruni 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 3 inclusion and 3 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 6 Jun 2023. 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?
Evaluation of Shoulder Pain and Functionality (SPADI) (time frame: 10 minutes). The study lists 3 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 6 Jun 2023.