Rheumatoid ArthritisNCT04820426
Evaluation of the Effect of Neuropathic Pain on Quality of Life in Rheumatoid Arthritis Patients
An observational study of Rheumatoid Arthritis and Neuropathic Pain, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Rheumatoid arthritis is a chronic inflammatory disease that mainly affects the joint synovium. Rheumatoid arthritis patients define pain as their major symptom and the most important reason for applying to a healthcare institution. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis, Neuropathic Pain
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 30 Nov 2022
- 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: Rheumatoid arthritis patients
Who may be able to join
- diagnosed with rheumatoid arthritis,
- who can read and write in Turkish,
- participant's admission participating in the study,
- participants who do not have exclusion criteria
Who cannot join
- participant's refusal to participate in the study,
- lack of cooperation due to cognitive impairment,
- participant's who have a neurological disease,
- presence of drug abuse,
- presence of malignancy in any organ or system,
- serious psychiatric problems (psychosis, etc.),
- the presence of another rheumatological disease other than Rheumatoid Arthritis,
- serious and unstable metabolic disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirsehir Ahi Evran University Hospital
Kırşehir
About this study
Rheumatoid arthritis is a chronic inflammatory disease that mainly affects the joint synovium. Rheumatoid arthritis patients define pain as their major symptom and the most important reason for applying to a healthcare institution. Approximately 70% of rheumatoid arthritis patients state that improvement in their pain compared to other symptoms of the disease is their priority. Pain in rheumatoid arthritis patients is also important as the disease affects approximately 0.5-1% of patients worldwide.
Although pain in rheumatoid arthritis patients can be persistent or intermittent, localized or widespread, it has often been associated with fatigue and psychosocial stress. Although nociceptive pain,defined as 'gnawing' or 'aching', is frequently observed in rheumatoid arthritis patients, typical neuropathic pain,such as 'burning' or 'itching', can be observed in some RA patients. It is thought that neuropathic pain may occur as a result of lesions or disease affecting the somatosensorial nervous system. Neuropathic pain can occur with little or no stimulus, and its symptoms are abnormal sensations such as hyperalgesia and allodynia.
Read more
The diagnosis and treatment of neuropathic pain in rheumatoid arthritis patients is important because neuropathic pain does not decrease with traditional disease-modifying anti-inflammatory drugs used in rheumatoid arthritis and causes a decrease in quality of life. In order to distinguish neuropathic pain from chronic pain, methods based on defining the quality of pain are often used. Some of these methods are; The McGill Pain Questionnaire, PainDETECT, RAPS (Rheumatoid Arthritis Pain Scale), VAS (visual analog scale), AIMS (Arthritis Impact Scale), EQ-5D (European Quality of Life Assessment and Pain Assessment Questionnaire).
The diagnosis and treatment of neuropathic pain in rheumatoid arthritis patients is important because neuropathic pain does not decrease with traditional disease-modifying anti-inflammatory drugs used in rheumatoid arthritis and causes a decrease in quality of life.
Read the detailed description
Rheumatoid arthritis is a chronic inflammatory disease that mainly affects the joint synovium. Rheumatoid arthritis patients define pain as their major symptom and the most important reason for applying to a healthcare institution. Approximately 70% of rheumatoid arthritis patients state that improvement in their pain compared to other symptoms of the disease is their priority. Pain in rheumatoid arthritis patients is also important as the disease affects approximately 0.5-1% of patients worldwide.
Synovial inflammation, which can lead to joint deformity by causing cartilage and bone destruction, is the main pathophysiological mechanism in rheumatoid arthritis, and therefore the main cause of pain in rheumatoid arthritis patients is thought to be nociceptive. Although pain in rheumatoid arthritis was previously associated with tissue damage and inflammatory processes in the joints, accumulated knowledge shows that peripheral inflammation, disease progression, structural and neurochemical changes in the joints and sensorial system, and central pain process mechanisms may also play a role in these rheumatoid arthritis patients.
Although pain in rheumatoid arthritis patients can be persistent or intermittent, localized or widespread, it has often been associated with fatigue and psychosocial stress. Although nociceptive pain, defined as 'gnawing' or 'aching', is frequently observed in rheumatoid arthritis patients, typical neuropathic pain, such as 'burning' or 'itching', can be observed in some RA patients. It is thought that neuropathic pain may occur as a result of lesions or disease affecting the somatosensorial nervous system. Neuropathic pain can occur with little or no stimulus, and its symptoms are abnormal sensations such as hyperalgesia and allodynia.
Although the frequency of neuropathic pain in rheumatoid arthritis patients varies in various clinical studies, it is approximately 20.7-30%. The diagnosis and treatment of neuropathic pain in rheumatoid arthritis patients is important because neuropathic pain does not decrease with traditional disease-modifying anti-inflammatory drugs used in rheumatoid arthritis and causes a decrease in quality of life. To distinguish neuropathic pain from chronic pain, methods based on defining the quality of pain are often used. Some of these methods are; The McGill Pain Questionnaire, PainDETECT, RAPS (Rheumatoid Arthritis Pain Scale), VAS (visual analogue scale), AIMS (Arthritis Impact Scale), EQ-5D (European Quality of Life Assessment and Pain Assessment Questionnaire).
Although non-steroidal anti-inflammatory drugs(NSAIDs) are used for pain in rheumatoid arthritis, it is not suitable for long-term disease control. It is important to start the use of disease-modifying agents (DMARDs) in the early period in patients.
Analgesic agents such as NSAIDs, acetaminophen, and opioids are used for pain in rheumatoid arthritis patients. However, some side effects of these drugs frequently limit their usage. Long-term opioid use in pain treatment is not recommended due to its side effects such as constipation, nausea and vomiting, and should be used with careful monitoring when necessary. Other drugs such as tricyclic antidepressants and topical capsaicin have been used in randomized controlled trials for pain management in RA with limited success.
- Conditions
- Rheumatoid Arthritis, Neuropathic Pain
- Keywords
- rheumatoid arthritis, neuropathic pain, pain in rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis patients | Rheumatoid arthritis patients will be evaluated in terms of the presence of neuropathic pain and its effect on the quality of life, at their admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of presence of neuropathic pain
With the "Mc Gill-Mellzack Pain Questionnaire" form, the location of the patients' pain, the nature and intensity of the pain and the relationship between time and pain will be questioned.
Measured: Participant's admission
Evaluation of participant's anxiety and depression
Participant's anxiety and depression will be measured with Hospital Anxiety and Depression Scale (HADS). The Scale contains 14 questions.(7 anxiety and 7 depression) Each question is scored 0 to 3.
8-10 scores mild, 11-14 scores moderate, 15-21 severe Anxiety and depression score will be measured separately.
Measured: Participant's admission
Participants' quality of life assessed with Short Form-36 Scale
SF-36 scale, which is a quality of life assessment scale and has 36 questions, will be used to learn the participants' views about their own health, how they feel and how well they can perform daily activities.
Measured: Participant's admission
Participants's body pain assessed by VAS
Pain will be questioned with Visual Analog Scale.(VAS) Visual Analog Scale is determined by measuring the distance (mm) on the 10 cm line, between anchor and the patient's mark. Providing a range of scores from 0-100.A higher score indicates greater pain intensity.
No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: Participant's admission
Evaluation of rheumatoid arthritis disease activity
Rheumatoid arthritis disease activity will be evaluated by DAS28-CRP (C Reactive Protein)
Measured: Participant's admission
Evaluation of rheumatoid arthritis remission
Boolean index criteria will be used for detect the remission.
Measured: Participant's admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Apr 2021
- Primary completion30 Sep 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YILDIZ GONCA DOGRU, Ahi Evran University Education and Research Hospital
- Investigators
- FIGEN TUNCAY, PROF.,M.D., Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820426
- Sponsor's protocol ID
- 2021-06/55
- Status last verified
- Feb 2023
- First submitted
- 25 Mar 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noda K, Tajima M, Oto Y, Saitou M, Yoshiga M, Otani K, Yoshida K, Kurosaka D. How do neuropathic pain-like symptoms affect health-related quality of life among patients with rheumatoid arthritis?: A comparison of multiple pain-related parameters. Mod Rheumatol. 2020 Sep;30(5):828-834. doi: 10.1080/14397595.2019.1650462. Epub 2019 Aug 9.
PubMed 31398076Ito S, Kobayashi D, Murasawa A, Narita I, Nakazono K. An Analysis of the Neuropathic Pain Components in Rheumatoid Arthritis Patients. Intern Med. 2018 Feb 15;57(4):479-485. doi: 10.2169/internalmedicine.9235-17. Epub 2017 Dec 8.
PubMed 29225253Bas DB, Su J, Wigerblad G, Svensson CI. Pain in rheumatoid arthritis: models and mechanisms. Pain Manag. 2016;6(3):265-84. doi: 10.2217/pmt.16.4. Epub 2016 Apr 18.
PubMed 27086843Koop SM, ten Klooster PM, Vonkeman HE, Steunebrink LM, van de Laar MA. Neuropathic-like pain features and cross-sectional associations in rheumatoid arthritis. Arthritis Res Ther. 2015 Sep 3;17(1):237. doi: 10.1186/s13075-015-0761-8.
PubMed 26335941
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Neuropathic Pain on Quality of Life in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT04820426
- Acronym / sponsor ID
- 2021-06/55
- Conditions
- Rheumatoid Arthritis, Neuropathic Pain
- Keywords
- rheumatoid arthritis, neuropathic pain, pain in rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 29 Mar 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.
Rheumatoid arthritis is a chronic inflammatory disease that mainly affects the joint synovium. Rheumatoid arthritis patients define pain as their major symptom and the most important reason for applying to a healthcare institution. Approximately 70% of rheumatoid arthritis patients state that improvement in their pain compared to other symptoms of the disease is their priority. Pain in rheumatoid arthritis patients is also important as the disease affects approximately 0.5-1% of patients worldwide.
Although pain in rheumatoid arthritis patients can be persistent or intermittent, localized or widespread, it has often been associated with fatigue and psychosocial stress. Although nociceptive pain,defined as 'gnawing' or 'aching', is frequently observed in rheumatoid arthritis patients, typical neuropathic pain,such as 'burning' or 'itching', can be observed in some RA patients. It is thought that neuropathic pain may occur as a result of lesions or disease affecting the somatosensorial nervous system. Neuropathic pain can occur with little or no stimulus, and its symptoms are abnormal sensations such as hyperalgesia and allodynia.
The diagnosis and treatment of neuropathic pain in rheumatoid arthritis patients is important because neuropathic pain does not decrease with traditional disease-modifying anti-inflammatory drugs used in rheumatoid arthritis and causes a decrease in quality of life. In order to distinguish neuropathic pain from chronic pain, methods based on defining the quality of pain are often used. Some of these methods are; The McGill Pain Questionnaire, PainDETECT, RAPS (Rheumatoid Arthritis Pain Scale), VAS (visual analog scale), AIMS (Arthritis Impact Scale), EQ-5D (European Quality of Life Assessment and Pain Assessment Questionnaire).
The diagnosis and treatment of neuropathic pain in rheumatoid arthritis patients is important because neuropathic pain does not decrease with traditional disease-modifying anti-inflammatory drugs used in rheumatoid arthritis and causes a decrease in quality of life.
Detailed description
Rheumatoid arthritis is a chronic inflammatory disease that mainly affects the joint synovium. Rheumatoid arthritis patients define pain as their major symptom and the most important reason for applying to a healthcare institution. Approximately 70% of rheumatoid arthritis patients state that improvement in their pain compared to other symptoms of the disease is their priority. Pain in rheumatoid arthritis patients is also important as the disease affects approximately 0.5-1% of patients worldwide.
Synovial inflammation, which can lead to joint deformity by causing cartilage and bone destruction, is the main pathophysiological mechanism in rheumatoid arthritis, and therefore the main cause of pain in rheumatoid arthritis patients is thought to be nociceptive. Although pain in rheumatoid arthritis was previously associated with tissue damage and inflammatory processes in the joints, accumulated knowledge shows that peripheral inflammation, disease progression, structural and neurochemical changes in the joints and sensorial system, and central pain process mechanisms may also play a role in these rheumatoid arthritis patients.
Although pain in rheumatoid arthritis patients can be persistent or intermittent, localized or widespread, it has often been associated with fatigue and psychosocial stress. Although nociceptive pain, defined as 'gnawing' or 'aching', is frequently observed in rheumatoid arthritis patients, typical neuropathic pain, such as 'burning' or 'itching', can be observed in some RA patients. It is thought that neuropathic pain may occur as a result of lesions or disease affecting the somatosensorial nervous system. Neuropathic pain can occur with little or no stimulus, and its symptoms are abnormal sensations such as hyperalgesia and allodynia.
Although the frequency of neuropathic pain in rheumatoid arthritis patients varies in various clinical studies, it is approximately 20.7-30%. The diagnosis and treatment of neuropathic pain in rheumatoid arthritis patients is important because neuropathic pain does not decrease with traditional disease-modifying anti-inflammatory drugs used in rheumatoid arthritis and causes a decrease in quality of life. To distinguish neuropathic pain from chronic pain, methods based on defining the quality of pain are often used. Some of these methods are; The McGill Pain Questionnaire, PainDETECT, RAPS (Rheumatoid Arthritis Pain Scale), VAS (visual analogue scale), AIMS (Arthritis Impact Scale), EQ-5D (European Quality of Life Assessment and Pain Assessment Questionnaire).
Although non-steroidal anti-inflammatory drugs(NSAIDs) are used for pain in rheumatoid arthritis, it is not suitable for long-term disease control. It is important to start the use of disease-modifying agents (DMARDs) in the early period in patients.
Analgesic agents such as NSAIDs, acetaminophen, and opioids are used for pain in rheumatoid arthritis patients. However, some side effects of these drugs frequently limit their usage. Long-term opioid use in pain treatment is not recommended due to its side effects such as constipation, nausea and vomiting, and should be used with careful monitoring when necessary. Other drugs such as tricyclic antidepressants and topical capsaicin have been used in randomized controlled trials for pain management in RA with limited success.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis patients | – | –Rheumatoid arthritis patients will be evaluated in terms of the presence of neuropathic pain and its effect on the quality of life, at their admission. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis patients
Key inclusion criteria (4 listed)
- diagnosed with rheumatoid arthritis,
- who can read and write in Turkish,
- participant's admission participating in the study,
- participants who do not have exclusion criteria
Key exclusion criteria (8 listed)
- participant's refusal to participate in the study,
- lack of cooperation due to cognitive impairment,
- participant's who have a neurological disease,
- presence of drug abuse,
- presence of malignancy in any organ or system,
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
Evaluation of presence of neuropathic pain
Time frame: Participant's admission
With the "Mc Gill-Mellzack Pain Questionnaire" form, the location of the patients' pain, the nature and intensity of the pain and the relationship between time and pain will be questioned.
Evaluation of participant's anxiety and depression
Time frame: Participant's admission
Participant's anxiety and depression will be measured with Hospital Anxiety and Depression Scale (HADS). The Scale contains 14 questions.(7 anxiety and 7 depression) Each question is scored 0 to 3. 8-10 scores mild, 11-14 scores moderate, 15-21 severe Anxiety and depression score will be measured separately.
Participants' quality of life assessed with Short Form-36 Scale
Time frame: Participant's admission
SF-36 scale, which is a quality of life assessment scale and has 36 questions, will be used to learn the participants' views about their own health, how they feel and how well they can perform daily activities.
Participants's body pain assessed by VAS
Time frame: Participant's admission
Pain will be questioned with Visual Analog Scale.(VAS) Visual Analog Scale is determined by measuring the distance (mm) on the 10 cm line, between anchor and the patient's mark. Providing a range of scores from 0-100.A higher score indicates greater pain intensity. No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Evaluation of rheumatoid arthritis disease activity
Time frame: Participant's admission
Rheumatoid arthritis disease activity will be evaluated by DAS28-CRP (C Reactive Protein)
Evaluation of rheumatoid arthritis remission
Time frame: Participant's admission
Boolean index criteria will be used for detect the remission.
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 8 Feb 2023.
- Background: PubMed 31398076Noda K, Tajima M, Oto Y, Saitou M, Yoshiga M, Otani K, Yoshida K, Kurosaka D. How do neuropathic pain-like symptoms affect health-related quality of life among patients with rheumatoid arthritis?: A comparison of multiple pain-related parameters. Mod Rheumatol. 2020 Sep;30(5):828-834. doi: 10.1080/14397595.2019.1650462. Epub 2019 Aug 9.
- Background: PubMed 29225253Ito S, Kobayashi D, Murasawa A, Narita I, Nakazono K. An Analysis of the Neuropathic Pain Components in Rheumatoid Arthritis Patients. Intern Med. 2018 Feb 15;57(4):479-485. doi: 10.2169/internalmedicine.9235-17. Epub 2017 Dec 8.
- Background: PubMed 27086843Bas DB, Su J, Wigerblad G, Svensson CI. Pain in rheumatoid arthritis: models and mechanisms. Pain Manag. 2016;6(3):265-84. doi: 10.2217/pmt.16.4. Epub 2016 Apr 18.
- Background: PubMed 26335941Koop SM, ten Klooster PM, Vonkeman HE, Steunebrink LM, van de Laar MA. Neuropathic-like pain features and cross-sectional associations in rheumatoid arthritis. Arthritis Res Ther. 2015 Sep 3;17(1):237. doi: 10.1186/s13075-015-0761-8.
- 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.
FIGEN TUNCAY, PROF.,M.D. principal investigator
Kirsehir Ahi Evran Universitesi
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 Rheumatoid Arthritis and Neuropathic Pain, run by Ahi Evran University Education and Research Hospital 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 8 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 8 Feb 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?
Evaluation of presence of neuropathic pain (time frame: Participant's admission). The study lists 6 primary outcomes in all. 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 NCT04820426, which also lists 4 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 8 Feb 2023.