Subacromial Pain SyndromeNCT04952623
Online Education to Improve the Management of Rotator Cuff Related Shoulder Pain
A study testing Rotator Cuff Related Shoulder Pain E-Learning Program in people with Subacromial Pain Syndrome and Rotator Cuff Injuries, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
A randomized controlled trial: Conservative treatments including physiotherapy and rehabilitation in the management of rotator cuff-related shoulder pain (RCRSP) are generally accepted as the first-line treatment approach, however, it is known that the disease-specific physiotherapy methods used by physiotherapists… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Subacromial Pain Syndrome, Rotator Cuff Injuries
- What is being tested?
- Rotator Cuff Related Shoulder Pain E-Learning Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2022to 3 Apr 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 3th or 4th grade physiotherapy students
Who cannot join
- Students who are not currently enrolled in 3th or 4th grade
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Online Education for Physiotherapy Students to Improve the Management of Rotator Cuff Related Shoulder Pain
A randomized controlled trial: Conservative treatments including physiotherapy and rehabilitation in the management of rotator cuff-related shoulder pain (RCRSP) are generally accepted as the first-line treatment approach, however, it is known that the disease-specific physiotherapy methods used by physiotherapists are highly variable. This may be caused by the insufficient knowledge of therapists about evidence-based interventions to RCRSP. The aim of this study is to develop the '' Rotator Cuff Related Shoulder Pain E-learning Program'' and evaluate its effect on students' knowledge and clinical reasoning skills related to evidence-based RCRSP interventions and their levels of confidence to have this knowledge compared with a control group.
Read the detailed description
Shoulder pain is one of society's most common musculoskeletal problems, with a prevalence defined between 16-26%. Almost 70% of shoulder pain complaints are caused by pathologies associated with the rotator cuff. Conservative treatments including physiotherapy are widely accepted as a first-line treatment approach in the management of shoulder pain and on the other hand, the variety of physiotherapy practice is conspicuous. Despite the majority of physiotherapists provide treatment in line with current evidence, passive modalities are still highly preferred by some physiotherapists. The gap between research evidence and practice could be slightly due to the lack of an up-to-date undergraduate physiotherapy curriculum about the RCRSP. Therefore, the aim of this study is to develop the '' Rotator Cuff Related Shoulder Pain E-learning Program'' and evaluate its effect on students' knowledge and clinical reasoning skills related to evidence-based RCRSP interventions and their levels of confidence to have this knowledge compared with a control group. A randomized controlled trial including 146 4th grade physiotherapy students will be conducted. Students will be randomized into an e-learning group (n=73) or wait-list control group (n=73). The primary outcome will be the RCRSP achievement test, and the secondary outcome will be the self-reported confidence in knowledge and clinical reasoning skills related to RCRSP. All data will be collected through an online survey, which will be applied in two different time periods: pre-intervention and post-intervention. All groups will first answer the questionnaire at the beginning (week 0) and after the study group's e-learning activity (4-5 weeks).
- Conditions
- Subacromial Pain Syndrome, Rotator Cuff Injuries
- Being tested
- Rotator Cuff Related Shoulder Pain E-Learning Program
- Keywords
- Online education, Shoulder pain, Physiotherapy
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator Cuff Related Shoulder Pain E-Learning ProgramOther
The RCRSP e-learning program is designed according to the ADDIE Instructional Design Model in light of current literature.
| Study group | Role | What they receive |
|---|---|---|
| E-learning Group | Experimental | Participants will enroll in a 4-week e-learning program immediately after completing the pre-intervention assessment measures. Receives: Other: Rotator Cuff Related Shoulder Pain E-Learning Program |
| Wait-list Control Group | Active comparator | Participants will enroll in a 4-week e-learning program, 4-5 weeks after completion of the pre-intervention assessment measures. Receives: Other: Rotator Cuff Related Shoulder Pain E-Learning Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff related shoulder pain achievement test
The RCRSP achievement test is consistent with 18 question items with multiple choices. The mean difficulty and KR-20 reliability coefficient of the test were calculated 0.59 and 0.84, respectively.
Measured: Change from baseline test scores at 4 weeks
Secondary outcomes (1)
Self-reported confidence in knowledge and clinical reasoning skills related to rotator cuff related shoulder pain
The 3-item Questionnaire requires participants to rate their confidence in their knowledge and clinical skills related to RCRSP, using a 5-point Likert Scale ('not at all confident', 'not very confident', 'somewhat confident', 'confident' and 'very confident').
Measured: Change from baseline self-reported scores at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start20 Nov 2022
- Primary completion10 Feb 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mine Gülden Polat, PhD., Study chair, Marmara UniversityBahar Ayberk, PhD., Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952623
- Sponsor's protocol ID
- 16.11.2020.95
- Status last verified
- Oct 2022
- First submitted
- 17 Jun 2021
- Last updated
- 6 Apr 2023
- 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 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Online Education for Physiotherapy Students to Improve the Management of Rotator Cuff Related Shoulder Pain
- ClinicalTrials.gov ID
- NCT04952623
- Acronym / sponsor ID
- 16.11.2020.95
- Conditions
- Subacromial Pain Syndrome, Rotator Cuff Injuries
- Keywords
- Online education, Shoulder pain, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 7 Jul 2021 (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.
A randomized controlled trial: Conservative treatments including physiotherapy and rehabilitation in the management of rotator cuff-related shoulder pain (RCRSP) are generally accepted as the first-line treatment approach, however, it is known that the disease-specific physiotherapy methods used by physiotherapists are highly variable. This may be caused by the insufficient knowledge of therapists about evidence-based interventions to RCRSP. The aim of this study is to develop the '' Rotator Cuff Related Shoulder Pain E-learning Program'' and evaluate its effect on students' knowledge and clinical reasoning skills related to evidence-based RCRSP interventions and their levels of confidence to have this knowledge compared with a control group.
Detailed description
Shoulder pain is one of society's most common musculoskeletal problems, with a prevalence defined between 16-26%. Almost 70% of shoulder pain complaints are caused by pathologies associated with the rotator cuff. Conservative treatments including physiotherapy are widely accepted as a first-line treatment approach in the management of shoulder pain and on the other hand, the variety of physiotherapy practice is conspicuous. Despite the majority of physiotherapists provide treatment in line with current evidence, passive modalities are still highly preferred by some physiotherapists. The gap between research evidence and practice could be slightly due to the lack of an up-to-date undergraduate physiotherapy curriculum about the RCRSP. Therefore, the aim of this study is to develop the '' Rotator Cuff Related Shoulder Pain E-learning Program'' and evaluate its effect on students' knowledge and clinical reasoning skills related to evidence-based RCRSP interventions and their levels of confidence to have this knowledge compared with a control group. A randomized controlled trial including 146 4th grade physiotherapy students will be conducted. Students will be randomized into an e-learning group (n=73) or wait-list control group (n=73). The primary outcome will be the RCRSP achievement test, and the secondary outcome will be the self-reported confidence in knowledge and clinical reasoning skills related to RCRSP. All data will be collected through an online survey, which will be applied in two different time periods: pre-intervention and post-intervention. All groups will first answer the questionnaire at the beginning (week 0) and after the study group's e-learning activity (4-5 weeks).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-learning Group | Experimental | Other: Rotator Cuff Related Shoulder Pain E-Learning ProgramParticipants will enroll in a 4-week e-learning program immediately after completing the pre-intervention assessment measures. |
| Wait-list Control Group | Active comparator | Other: Rotator Cuff Related Shoulder Pain E-Learning ProgramParticipants will enroll in a 4-week e-learning program, 4-5 weeks after completion of the pre-intervention assessment measures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 3th or 4th grade physiotherapy students
Key exclusion criteria (1 listed)
- Students who are not currently enrolled in 3th or 4th grade
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 |
|---|---|---|
| Rotator Cuff Related Shoulder Pain E-Learning ProgramThe RCRSP e-learning program is designed according to the ADDIE Instructional Design Model in light of current literature. | Other | E-learning Group, Wait-list Control Group |
Primary outcome
Rotator cuff related shoulder pain achievement test
Time frame: Change from baseline test scores at 4 weeks
The RCRSP achievement test is consistent with 18 question items with multiple choices. The mean difficulty and KR-20 reliability coefficient of the test were calculated 0.59 and 0.84, respectively.
1 secondary outcome
Self-reported confidence in knowledge and clinical reasoning skills related to rotator cuff related shoulder pain
Time frame: Change from baseline self-reported scores at 4 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 6 Apr 2023.
- 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.
Mine Gülden Polat, PhD. study chair
Marmara University
Bahar Ayberk, PhD. principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotator Cuff Related Shoulder Pain E-Learning Program in people with Subacromial Pain Syndrome and Rotator Cuff Injuries, run by Marmara 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 1 inclusion and 1 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 Apr 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?
Rotator cuff related shoulder pain achievement test (time frame: Change from baseline test scores at 4 weeks). 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 Apr 2023.