End Stage Renal DiseaseNCT04188210
Elbow Pain in Hemodialysis Patients and Its Effect on Daily Living Activities of the Patients
An observational study of End Stage Renal Disease, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The study will include the patients undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Presence of elbow pain in patients with end stage renal disease
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Apr 2019
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients with end stage renal disease
Who may be able to join
- being over 18 years old having hemodialysis treatment
Who cannot join
- any surgical operation at upper extremity in last 3 months, the presence of conditions such as cancer, chronic hearing loss and neurologic diseases can affect the interview.
Trial locations and contacts
1 site in 1 country.
About this study
The study will include the patients undergoing hemodialysis.
Read the detailed description
The study will include the patients undergoing hemodialysis. The patients with surgery at upper extremity in last 3 months, the presence of conditions such as cancer, chronic hearing loss and neurologic diseases affect the interview will be excluded. Sociodemographic properties which include age, gender, duration of dialysis, educational level, comorbid diseases, vascular access area, hand dominancy will be asked. The Beck Depression Inventory (BDI), the Nottingham Health Profile (NHP), the Disabilities of the Arm, Shoulder and Hand Score (Q-DASH) and Visual Analogue Scale (VAS) will applied to all patients.
All the demographic results and vascular access area for hemodialysis will be detected. All data for normality will be tested by using Kolmogorov-Smirnov test. To compare the differences between groups, Mann Whitney U test will be used
- Conditions
- End Stage Renal Disease
- Being tested
- Presence of elbow pain in patients with end stage renal disease
- Keywords
- musculoskeletal pain, elbow pain, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of elbow pain in patients with end stage renal diseaseOther
The Beck Depression Inventory (BDI), the Nottingham Health Profile (NHP) scores were measured for all patients to evaluate depression symptoms and health-related quality of life. The elbow pain presence was asked to all the patients, the patients with elbow pain were also evaluated with The Disabilities of the Arm, Shoulder and Hand Score (Q-DASH) and Visual Analogue Scale (VAS). VAS detected as pain during rest, activity, night and pain at last week.
What is being measured
The primary outcome is the main question the study is designed to answer.
Kolmogorov-Smirnov test
All data for normality was tested by using Kolmogorov-Smirnov test
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Mar 2019
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Tepeli, Namik Kemal University
- Investigators
- betül tepeli, Principal investigator, private balkan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188210
- Sponsor's protocol ID
- 2019
- Status last verified
- Nov 2019
- First submitted
- 29 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fidan F, Alkan BM, Tosun A, Altunoglu A, Ardicoglu O. Quality of life and correlation with musculoskeletal problems, hand disability and depression in patients with hemodialysis. Int J Rheum Dis. 2016 Feb;19(2):159-66. doi: 10.1111/1756-185X.12171. Epub 2013 Oct 31.
PubMed 24176031Kane SF, Lynch JH, Taylor JC. Evaluation of elbow pain in adults. Am Fam Physician. 2014 Apr 15;89(8):649-57.
PubMed 24784124
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elbow Pain in Hemodialysis Patients and Its Effect on Daily Living Activities of the Patients
- ClinicalTrials.gov ID
- NCT04188210
- Acronym / sponsor ID
- 2019
- Conditions
- End Stage Renal Disease
- Keywords
- musculoskeletal pain, elbow pain, hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 5 Dec 2019 (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 study will include the patients undergoing hemodialysis.
Detailed description
The study will include the patients undergoing hemodialysis. The patients with surgery at upper extremity in last 3 months, the presence of conditions such as cancer, chronic hearing loss and neurologic diseases affect the interview will be excluded. Sociodemographic properties which include age, gender, duration of dialysis, educational level, comorbid diseases, vascular access area, hand dominancy will be asked. The Beck Depression Inventory (BDI), the Nottingham Health Profile (NHP), the Disabilities of the Arm, Shoulder and Hand Score (Q-DASH) and Visual Analogue Scale (VAS) will applied to all patients.
All the demographic results and vascular access area for hemodialysis will be detected. All data for normality will be tested by using Kolmogorov-Smirnov test. To compare the differences between groups, Mann Whitney U test will be used
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients with end stage renal disease
Key inclusion criteria (1 listed)
- being over 18 years old having hemodialysis treatment
Key exclusion criteria (1 listed)
- any surgical operation at upper extremity in last 3 months, the presence of conditions such as cancer, chronic hearing loss and neurologic diseases can affect the interview.
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 |
|---|---|---|
| Presence of elbow pain in patients with end stage renal diseaseThe Beck Depression Inventory (BDI), the Nottingham Health Profile (NHP) scores were measured for all patients to evaluate depression symptoms and health-related quality of life. The elbow pain presence was asked to all the patients, the patients with elbow pain were also evaluated with The Disabilities of the Arm, Shoulder and Hand Score (Q-DASH) and Visual Analogue Scale (VAS). VAS detected as pain during rest, activity, night and pain at last week. | Other | – |
Primary outcome
Kolmogorov-Smirnov test
Time frame: through study completion, an average of 1 month
All data for normality was tested by using Kolmogorov-Smirnov test
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 5 Dec 2019.
- Results publication: PubMed 24176031Fidan F, Alkan BM, Tosun A, Altunoglu A, Ardicoglu O. Quality of life and correlation with musculoskeletal problems, hand disability and depression in patients with hemodialysis. Int J Rheum Dis. 2016 Feb;19(2):159-66. doi: 10.1111/1756-185X.12171. Epub 2013 Oct 31.
- Results publication: PubMed 24784124Kane SF, Lynch JH, Taylor JC. Evaluation of elbow pain in adults. Am Fam Physician. 2014 Apr 15;89(8):649-57.
- Individual participant dataSharing planned: Undecided
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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.
betül tepeli principal investigator
private balkan hospital
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 End Stage Renal Disease, run by Namik Kemal 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 5 Dec 2019. 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?
Kolmogorov-Smirnov test (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04188210, which also lists 2 linked publications.
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 5 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.