Neuropathic PainNCT06798181
Neuropathic Pain and Type II Diabetic Patients
An observational study of Neuropathic Pain and Quality of Life, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Diabetes Mellitus (DM) is a common metabolic disease characterized by hyperglycemia resulting from insufficiency, deficiency or absence of the insulin hormone. Chronic hyperglycemia, secondary metabolic and microvascular changes resulting in diabetic neuropathy are among the most common complications encountered in DM… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neuropathic Pain, Quality of Life, Diabetic Neuropathies
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals over the age of 18 diagnosed with Type II diabetes
Who may be able to join
- 18 years and older,
- Diagnosed with type II diabetes,
- Reading and writing,
- No physical or psychological communication barriers,
- Can read and speak Turkish,
- Volunteers
Who cannot join
- Diagnosed with type I diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Neuropathic Pain on Self-Care Ability and Quality of Life in Type II Diabetic Patients
Diabetes Mellitus (DM) is a common metabolic disease characterized by hyperglycemia resulting from insufficiency, deficiency or absence of the insulin hormone. Chronic hyperglycemia, secondary metabolic and microvascular changes resulting in diabetic neuropathy are among the most common complications encountered in DM patients.
Diabetic neuropathy is called peripheral, autonomic or spinal depending on the region of involvement. Peripheral involvement is more common than other region involvement and its prevalence in DM patients is observed to be 16-87%. Diabetic peripheral neuropathy (DPN) presents with numbness, tingling, paresthesia, muscle weakness and pain. These symptoms can start from the toes and progress to the leg and even the upper extremities.
In diabetic peripheral neuropathy, pain is seen as burning, electric shock or sharp cold pain, increases at night and affects sleep quality. In these patients, daily living activities such as walking, climbing stairs, and sleeping are negatively affected by progressive DPN and pain, falls are observed, mood disorders are experienced, and the quality of life decreases.
Read the detailed description
In the study, the Data Descriptive Characteristics Form, Diabetes Quality of Life Scale, Self-Care Efficacy Scale, Neuropathic Symptoms and Signs Self-Assessment Scale and Visual Analog Scale will be used. Data will be collected using face-to-face interview technique with patients who apply to the Internal Medicine Outpatient Clinic and are diagnosed with Type II Diabetes. The researchers will conduct the data collection process between 09:00-16:00 on weekdays. After the patients are informed about the research, their informed consent will be obtained and they will be included in the study.
The Descriptive Characteristics Form was developed by the researchers by reviewing the relevant literature. It consists of 17 questions including information such as age, gender, chronic diseases, and medications used.
The original version of the Diabetes Quality of Life Scale, Diabetes Quality of Life (DQOL) scale was developed in 1988 by the Diabetes Control and Complications Study group.The Turkish culturally compatible version of the DQOL scale consists of four sub-dimensions and a total of 45 questions. The Cronbach α coefficient of the Turkish version of the DQOL scale translated by Yıldırım is 0.89.
Self-Care Agency Scale: The Self-Care Agency Scale was developed in 1979 and was adapted to Turkish in the Republic of Turkey and its validity and reliability were performed. The scale, which focuses on individuals' self-assessment of their involvement in self-care actions, consists of 35 items. The Cronbach Alpha Internal Consistency Coefficient of the scale was found to be 0.89.
VAS-Visual Analog Scale It is a scale divided into equal distances on a 10 cm horizontal plane with no pain on one side and "unbearable" pain on the other side. The patient is asked to mark the point on this line that best expresses the intensity of his/her pain. This distance, measured in millimeters, is interpreted as a "score". For pain intensity, 0 points are evaluated as "no pain" and 10 points as "the worst unbearable pain".
S-LANSS It is used especially in the evaluation of pain types with neuropathic characteristics. - It can be applied easily and quickly at the bedside. It provides the distinction between neuropathic and nociceptive pain. There are 7 items in total, 5 of which are pain questions and 2 of which are allodynia and needle prick test examinations. 0 Its validity and reliability in our country was conducted by Koç in 2008. The Cronbach alpha value of the scale was calculated as 0.74
- Conditions
- Neuropathic Pain, Quality of Life, Diabetic Neuropathies
- Medical subject headings
- Neuralgia, Diabetic Neuropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic pain
Self-Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS) will be used to assess neuropathic pain types. When the score obtained from this scale consisting of 7 items is >12, neuropathic pain is diagnosed.
Measured: 15/12/2024-30/07/2025
the pain severity
As the first outcome of the study, the patients' neuropathic pain status and pain intensity will be determined. The following scales will be used for this.
VAS-Visual Analog Scale will be used to assess pain. Scoring will be between 0-10.
Measured: 15/12/2024-30/07/2025
Secondary outcomes (2)
Quality of life will be measured with the Diabetes Quality of Life (DQOL) scale
In the study, the quality of life be measured with the Diabetes Quality of Life (DQOL) scale of life of the patients will be measured with the Diabetes Quality of Life (DQOL) scale. 45 questions will be asked in this scale and the answers will be scored.
Measured: 15/12/2024-30/07/2025
the Self-Care Agency Scale
In addition, the Self-Care Agency of the patients will be evaluated. For this, the Self-Care Agency Scale will be used. This scale consists of 35 items. As the score obtained from the scale increases, the self-care agency increases.
Measured: 15/12/2024-30/07/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start15 Dec 2024
- Primary completion15 Jun 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798181
- Sponsor's protocol ID
- Burcu Bayrak 3
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuropathic Pain on Self-Care Ability and Quality of Life in Type II Diabetic Patients
- ClinicalTrials.gov ID
- NCT06798181
- Acronym / sponsor ID
- Burcu Bayrak 3
- Conditions
- Neuropathic Pain, Quality of Life, Diabetic Neuropathies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Jan 2025 (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.
Diabetes Mellitus (DM) is a common metabolic disease characterized by hyperglycemia resulting from insufficiency, deficiency or absence of the insulin hormone. Chronic hyperglycemia, secondary metabolic and microvascular changes resulting in diabetic neuropathy are among the most common complications encountered in DM patients.
Diabetic neuropathy is called peripheral, autonomic or spinal depending on the region of involvement. Peripheral involvement is more common than other region involvement and its prevalence in DM patients is observed to be 16-87%. Diabetic peripheral neuropathy (DPN) presents with numbness, tingling, paresthesia, muscle weakness and pain. These symptoms can start from the toes and progress to the leg and even the upper extremities.
In diabetic peripheral neuropathy, pain is seen as burning, electric shock or sharp cold pain, increases at night and affects sleep quality. In these patients, daily living activities such as walking, climbing stairs, and sleeping are negatively affected by progressive DPN and pain, falls are observed, mood disorders are experienced, and the quality of life decreases.
Detailed description
In the study, the Data Descriptive Characteristics Form, Diabetes Quality of Life Scale, Self-Care Efficacy Scale, Neuropathic Symptoms and Signs Self-Assessment Scale and Visual Analog Scale will be used. Data will be collected using face-to-face interview technique with patients who apply to the Internal Medicine Outpatient Clinic and are diagnosed with Type II Diabetes. The researchers will conduct the data collection process between 09:00-16:00 on weekdays. After the patients are informed about the research, their informed consent will be obtained and they will be included in the study.
The Descriptive Characteristics Form was developed by the researchers by reviewing the relevant literature. It consists of 17 questions including information such as age, gender, chronic diseases, and medications used.
The original version of the Diabetes Quality of Life Scale, Diabetes Quality of Life (DQOL) scale was developed in 1988 by the Diabetes Control and Complications Study group.The Turkish culturally compatible version of the DQOL scale consists of four sub-dimensions and a total of 45 questions. The Cronbach α coefficient of the Turkish version of the DQOL scale translated by Yıldırım is 0.89.
Self-Care Agency Scale: The Self-Care Agency Scale was developed in 1979 and was adapted to Turkish in the Republic of Turkey and its validity and reliability were performed. The scale, which focuses on individuals' self-assessment of their involvement in self-care actions, consists of 35 items. The Cronbach Alpha Internal Consistency Coefficient of the scale was found to be 0.89.
VAS-Visual Analog Scale It is a scale divided into equal distances on a 10 cm horizontal plane with no pain on one side and "unbearable" pain on the other side. The patient is asked to mark the point on this line that best expresses the intensity of his/her pain. This distance, measured in millimeters, is interpreted as a "score". For pain intensity, 0 points are evaluated as "no pain" and 10 points as "the worst unbearable pain".
S-LANSS It is used especially in the evaluation of pain types with neuropathic characteristics. - It can be applied easily and quickly at the bedside. It provides the distinction between neuropathic and nociceptive pain. There are 7 items in total, 5 of which are pain questions and 2 of which are allodynia and needle prick test examinations. 0 Its validity and reliability in our country was conducted by Koç in 2008. The Cronbach alpha value of the scale was calculated as 0.74
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals over the age of 18 diagnosed with Type II diabetes
Key inclusion criteria (6 listed)
- 18 years and older,
- Diagnosed with type II diabetes,
- Reading and writing,
- No physical or psychological communication barriers,
- Can read and speak Turkish,
Key exclusion criteria (1 listed)
- Diagnosed with type I diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuropathic pain
Time frame: 15/12/2024-30/07/2025
Self-Leeds Assessment of Neuropathic Symptoms and Sign (S-LANSS) will be used to assess neuropathic pain types. When the score obtained from this scale consisting of 7 items is >12, neuropathic pain is diagnosed.
the pain severity
Time frame: 15/12/2024-30/07/2025
As the first outcome of the study, the patients' neuropathic pain status and pain intensity will be determined. The following scales will be used for this. VAS-Visual Analog Scale will be used to assess pain. Scoring will be between 0-10.
2 secondary outcomes
Quality of life will be measured with the Diabetes Quality of Life (DQOL) scale
Time frame: 15/12/2024-30/07/2025
the Self-Care Agency Scale
Time frame: 15/12/2024-30/07/2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neuropathic Pain and Quality of Life, run by Bilecik Seyh Edebali Universitesi 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 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Neuropathic pain (time frame: 15/12/2024-30/07/2025). The study lists 2 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 16 Sep 2026.