NCT05828706

Brief 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. (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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

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

Study Start

First participant enrolled

April 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

April 12, 2023

Last Update Submit

June 5, 2023

Conditions

Keywords

balanceshoulder painmobilityfunctionality

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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).

    10 minutes

Eligibility Criteria

Age41 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Having vision and hearing problems
  • Having other accompanying neurological, psychiatric and/or orthopedic problems other than shoulder pathologies
  • Having a pregnancy status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Bezmialem Vakif University Faculty of Medicine, Department of Physical Medicine and Rehabilitation.

Istanbul, 347093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder InjuriesShoulder Pain

Condition Hierarchy (Ancestors)

Wounds and InjuriesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

April 1, 2023

Primary Completion

May 26, 2023

Study Completion

May 30, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06

Locations