Shoulder ImpingementNCT04538118
Relationship of Patient-Specific Functional Scale With Shoulder Functions: A Prospective Study
An observational study of Shoulder Impingement and Frozen Shoulder, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the relationship between the Patient- Specific Functional Scale (PSFS) and shoulder functions in the physiotherapy and rehabilitation program applied to patients with shoulder problems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Impingement, Frozen Shoulder, Humeral Fractures
- What is being tested?
- Shoulder disability, Shoulder Range of Motion and Pain Intensity
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2019to 25 May 2019
- How long will I take part?
- 6 Weeks
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with shoulder problems
Who may be able to join
- having a shoulder pathology
- being volunteer
- having shoulder pain at least 3 months
- being literate
Who cannot join
- having more than one upper extremity pathology
- having an upper extremity pathology involving the neck and trunk
- having a neurological finding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship of Patient-Specific Functional Scale With Shoulder Functions in Physiotherapy and Rehabilitation Program Applied to Patients With Shoulder Problems
The aim of the study is to examine the relationship between the Patient- Specific Functional Scale (PSFS) and shoulder functions in the physiotherapy and rehabilitation program applied to patients with shoulder problems.
- Conditions
- Shoulder Impingement, Frozen Shoulder, Humeral Fractures, Rotator Cuff Tears, Disability Physical, Pain, Shoulder
- Being tested
- Shoulder disability, Shoulder Range of Motion, Pain Intensity
- Medical subject headings
- Shoulder Impingement Syndrome, Bursitis, Humeral Fractures, Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder disabilityBehavioural
Shoulder disability was evaluated with Patient-specific functional scale, the disabilities of the shoulder, arm and hand questionnaire, and the upper extremity functional index.
First assessment was applied when patients came to physical therapy clinic at first.
Second assessment was repeated after 6 weeks.
Shoulder Range of MotionDevice
Shoulder range of motion was evaluated with universal goniometer. First assessment was applied when patients came to physical therapy clinic at first.
Second assessment was repeated after 6 weeks.
Pain IntensityBehavioural
Pain intensity was evaluated with Numeric Pain Rating Scale. First assessment was applied when patients came to physical therapy clinic at first.
Second assessment was repeated after 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Patient with a shoulder problem | Patients with shoulder problems between 18-65 years of age and being volunteered Receives: Behavioral: Shoulder disability; Device: Shoulder Range of Motion; Behavioral: Pain Intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Disability was evaluated with Patient-Specific Functional Scale.Patients nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their injury or problem. These activities are rated on an 11-point scale, where 0 is unable to perform the activity and 10 is able to perform the activity at preinjury level.
Measured: 6 weeks
Activity Limitation
Activity limitation was evaluated with The Disabilities of the Arm, Shoulder and Hand. Scale score ranges from 0 (no disability) to 100 (most severe disability).
Measured: 6 weeks
Functional Disorder
Disability was evaluated with Upper-Extremity Functional Index.Twenty prescribed upper extremity activities are rated by patients according to a 5-point scale, where 0 is extreme difficulty or unable to perform the activity, and 4 is no difficulty. Higher scores mean better outcome scores.
Measured: 6 weeks
Secondary outcomes (2)
Pain Intensity
Pain was evaluated with Numeric Pain Rating Scale. It requires the patient to rate their pain on a defined scale. 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: 6 weeks
Range of Motion
Shoulder range of motion was evaluated with universal goniometer
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start5 Jan 2019
- Primary completion25 Feb 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ImpingementStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hidayet Cuha, MSc, Study chair, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538118
- Sponsor's protocol ID
- 363-37
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- 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 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Patient-Specific Functional Scale With Shoulder Functions in Physiotherapy and Rehabilitation Program Applied to Patients With Shoulder Problems
- ClinicalTrials.gov ID
- NCT04538118
- Acronym / sponsor ID
- 363-37
- Conditions
- Shoulder Impingement, Frozen Shoulder, Humeral Fractures, Rotator Cuff Tears, Disability Physical, Pain, Shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 3 Sep 2020 (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 the study is to examine the relationship between the Patient- Specific Functional Scale (PSFS) and shoulder functions in the physiotherapy and rehabilitation program applied to patients with shoulder problems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with a shoulder problem | – | Behavioral: Shoulder disability, Device: Shoulder Range of Motion, Behavioral: Pain IntensityPatients with shoulder problems between 18-65 years of age and being volunteered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with shoulder problems
Key inclusion criteria (4 listed)
- having a shoulder pathology
- being volunteer
- having shoulder pain at least 3 months
- being literate
Key exclusion criteria (3 listed)
- having more than one upper extremity pathology
- having an upper extremity pathology involving the neck and trunk
- having a neurological finding
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 |
|---|---|---|
| Shoulder disabilityShoulder disability was evaluated with Patient-specific functional scale, the disabilities of the shoulder, arm and hand questionnaire, and the upper extremity functional index. First assessment was applied when patients came to physical therapy clinic at first. Second assessment was repeated after 6 weeks. | Behavioural | Patient with a shoulder problem |
| Shoulder Range of MotionShoulder range of motion was evaluated with universal goniometer. First assessment was applied when patients came to physical therapy clinic at first. Second assessment was repeated after 6 weeks. | Device | Patient with a shoulder problem |
| Pain IntensityPain intensity was evaluated with Numeric Pain Rating Scale. First assessment was applied when patients came to physical therapy clinic at first. Second assessment was repeated after 6 weeks. | Behavioural | Patient with a shoulder problem |
Primary outcome
Disability
Time frame: 6 weeks
Disability was evaluated with Patient-Specific Functional Scale.Patients nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their injury or problem. These activities are rated on an 11-point scale, where 0 is unable to perform the activity and 10 is able to perform the activity at preinjury level.
Activity Limitation
Time frame: 6 weeks
Activity limitation was evaluated with The Disabilities of the Arm, Shoulder and Hand. Scale score ranges from 0 (no disability) to 100 (most severe disability).
Functional Disorder
Time frame: 6 weeks
Disability was evaluated with Upper-Extremity Functional Index.Twenty prescribed upper extremity activities are rated by patients according to a 5-point scale, where 0 is extreme difficulty or unable to perform the activity, and 4 is no difficulty. Higher scores mean better outcome scores.
2 secondary outcomes
Pain Intensity
Time frame: 6 weeks
Range of Motion
Time frame: 6 weeks
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 7 Sep 2020.
- 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.
Hidayet Cuha, MSc study chair
Ankara Yildirim Beyazıt University
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 Impingement and Frozen Shoulder, run by Ankara Yildirim Beyazıt 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 4 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 7 Sep 2020. 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?
Disability (time frame: 6 weeks). 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 7 Sep 2020.