QuestionnaireNCT06293001
Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the ADAP Shoulder Scale
An observational study of Questionnaire and Shoulder Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Shoulder pain is a common musculoskeletal problem that increases disability and decreases quality of life in addition to socio-economic impact. Chronic pain is defined as pain lasting longer than three months. Chronic pain is a multidimensional and complex experience. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Questionnaire, Shoulder Pain, Validity
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2023to 30 Jun 2024
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with shoulder pain were included in the study. Patients with shoulder pain, pain for at least three months and aged between 18 and 64 years, and for the re-test only participants with unchanged health status were included in the study. Patients with rheumatological, neurological or musculoskeletal diseases, invasive intervention in the last 3 months, active infection, history of cancer, post-traumatic condition requiring surgery were excluded.
Who may be able to join
- Patients with shoulder pain who have had pain for at least three months The ages between of 18 and 64.
Who cannot join
- Rheumatological, neurological or musculoskeletal diseases, Non-invasive interventions performed in the last 3 months, Active infections, History of cancer, Conditions requiring post-traumatic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Avoidance of Daily Activities Photo Scale for Patients With Shoulder Pain (ADAP Shoulder Scale)
Shoulder pain is a common musculoskeletal problem that increases disability and decreases quality of life in addition to socio-economic impact. Chronic pain is defined as pain lasting longer than three months. Chronic pain is a multidimensional and complex experience. According to this model, chronic pain is a multidimensional and complex experience. This experience may be accompanied by different pain beliefs, pain avoidance behaviours, pain-related fear of movement, anxiety and depression. Many conditions involving the shoulder complex including traumatic and non-traumatic pain, subacromial impingement, postoperative pain, rotator sheath tears, rotator sheath tendinopathy, shoulder arthritis, adhesive capsulitis, shoulder instabilities may lead to pain-related fear of movement.
Until now, pain-related fear and avoidance behaviours in patients with shoulder pain have been evaluated with the Tampa Kinesiophobia Scale, Pain Avoidance Beliefs Scale and Fear of Pain Scale. However, only patients with low back pain were included in the development of these scales. There was no scale developed specifically for shoulder pain. To fill this gap in the literature, Ansanello et al. developed the "Avoidance Daily Activities Photo Scale for Patients With Shoulder Pain (ADAP)" scale to evaluate pain avoidance behaviours in individuals with shoulder pain. Cross-cultural adaptation, validity and reliability of the Turkish version of the ADAP scale has not been studied.
The aim of our study was to perform cross-cultural adaptation, validity and reliability of the Turkish version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale).
Read the detailed description
The research will be conducted at Hacettepe University Faculty of Physical Therapy and Rehabilitation, Athlete Health Unit. The research will be conducted according to the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines.
Translation and cross-cultural adaptation of the ADAP Shoulder Scale will be carried out in five stages according to standard guidelines for scale translation and cross-cultural adaptation.It was planned to include 150 individuals with shoulder pain between the ages of 18 to 64 in the study.
The data collection for this planned study will be solely through surveys. The design of the study is a cross-sectional study aimed at developing and assessing the validity and reliability." Surveys specific to the research will be implemented in the study.
- Conditions
- Questionnaire, Shoulder Pain, Validity, Reliability
- Being tested
- No intervention
- Keywords
- Questionnaire, Shoulder pain, Validity, Reliability, Cross-cultural adaptation
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with shoulder pain | Patients with shoulder pain, pain for at least three months and aged between 18 and 64 years, and for the re-test only participants with unchanged health status were included in the study. Patients with rheumatological, neurological or musculoskeletal diseases, invasive intervention in the last 3 months, active infection, history of cancer, post-traumatic condition requiring surgery were excluded. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale)
A score of 0 represents the best score and a score of 10 represents the worst score and indicates worsening of the symptom.
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 posted5 Mar 2024
- Study start28 Nov 2023
- Primary completion26 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QuestionnaireStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Turgut, Hacettepe University
- Investigators
- Elif Turgut, Ass. Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293001
- Sponsor's protocol ID
- SBA 23/349
- Status last verified
- Jul 2024
- First submitted
- 19 Feb 2024
- Last updated
- 19 Jul 2024
- 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 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Avoidance of Daily Activities Photo Scale for Patients With Shoulder Pain (ADAP Shoulder Scale)
- ClinicalTrials.gov ID
- NCT06293001
- Acronym / sponsor ID
- SBA 23/349
- Conditions
- Questionnaire, Shoulder Pain, Validity, Reliability
- Keywords
- Questionnaire, Shoulder pain, Validity, Reliability, Cross-cultural adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Mar 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.
Shoulder pain is a common musculoskeletal problem that increases disability and decreases quality of life in addition to socio-economic impact. Chronic pain is defined as pain lasting longer than three months. Chronic pain is a multidimensional and complex experience. According to this model, chronic pain is a multidimensional and complex experience. This experience may be accompanied by different pain beliefs, pain avoidance behaviours, pain-related fear of movement, anxiety and depression. Many conditions involving the shoulder complex including traumatic and non-traumatic pain, subacromial impingement, postoperative pain, rotator sheath tears, rotator sheath tendinopathy, shoulder arthritis, adhesive capsulitis, shoulder instabilities may lead to pain-related fear of movement.
Until now, pain-related fear and avoidance behaviours in patients with shoulder pain have been evaluated with the Tampa Kinesiophobia Scale, Pain Avoidance Beliefs Scale and Fear of Pain Scale. However, only patients with low back pain were included in the development of these scales. There was no scale developed specifically for shoulder pain. To fill this gap in the literature, Ansanello et al. developed the "Avoidance Daily Activities Photo Scale for Patients With Shoulder Pain (ADAP)" scale to evaluate pain avoidance behaviours in individuals with shoulder pain. Cross-cultural adaptation, validity and reliability of the Turkish version of the ADAP scale has not been studied.
The aim of our study was to perform cross-cultural adaptation, validity and reliability of the Turkish version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale).
Detailed description
The research will be conducted at Hacettepe University Faculty of Physical Therapy and Rehabilitation, Athlete Health Unit. The research will be conducted according to the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines.
Translation and cross-cultural adaptation of the ADAP Shoulder Scale will be carried out in five stages according to standard guidelines for scale translation and cross-cultural adaptation.It was planned to include 150 individuals with shoulder pain between the ages of 18 to 64 in the study.
The data collection for this planned study will be solely through surveys. The design of the study is a cross-sectional study aimed at developing and assessing the validity and reliability." Surveys specific to the research will be implemented in the study.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with shoulder pain | – | Other: No interventionPatients with shoulder pain, pain for at least three months and aged between 18 and 64 years, and for the re-test only participants with unchanged health status were included in the study. Patients with rheumatological, neurological or musculoskeletal diseases, invasive intervention in the last 3 months, active infection, history of cancer, post-traumatic condition requiring surgery were excluded. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with shoulder pain were included in the study. Patients with shoulder pain, pain for at least three months and aged between 18 and 64 years, and for the re-test only participants with unchanged health status were included in the study. Patients with rheumatological, neurological or musculoskeletal diseases, invasive intervention in the last 3 months, active infection, history of cancer, post-traumatic condition requiring surgery were excluded.
Key inclusion criteria (1 listed)
- Patients with shoulder pain who have had pain for at least three months The ages between of 18 and 64.
Key exclusion criteria (1 listed)
- Rheumatological, neurological or musculoskeletal diseases, Non-invasive interventions performed in the last 3 months, Active infections, History of cancer, Conditions requiring post-traumatic surgery.
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 |
|---|---|---|
| No interventionNo intervention | Other | Patients with shoulder pain |
Primary outcome
Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale)
Time frame: 10 minutes
A score of 0 represents the best score and a score of 10 represents the worst score and indicates worsening of the symptom.
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 19 Jul 2024.
- 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.
Elif Turgut, Ass. Prof. study director
Hacettepe 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 Questionnaire and Shoulder Pain, run by Hacettepe 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 19 Jul 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?
Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale) (time frame: 10 minutes). 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 19 Jul 2024.