An observational study in Knee Osteoarthritis, Sleep Disturbance and Neuropathic Pain, sponsored by Bozyaka Training and Research Hospital. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by Bozyaka Training and Research Hospital · Observational
Among 268 studies in Osteoarthritis, Knee with a site in Turkey — 54 open to participants now, 66 under way, 3 of them phase 3. Osteoarthritis, Knee · Turkey.
Among the 268 studies in Osteoarthritis, Knee with a site in Turkey, this one is the 14th largest by planned enrollment of the 70 observational ones, is one of 28 that started in 2024, is one of 70 observational ones, reaches primary completion later than 38 of the 65 other live ones, and was the 155th registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →54 of the 268 studies in Osteoarthritis, Knee with a site in Turkey are open now, in 11 countries. Each count lists the studies.
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →268 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 28 started in 2024.
Median enrollment 60 across the 198 interventional studies, 84 across the 70 observational. Of the 180 that completed or were terminated, 3 (2%) have results posted.
5 of 268 have an industry lead sponsor. The 10 most frequent:
Bozyaka Training and Research Hospital is the lead sponsor of 51 studies on the registry; 5 are open to participants now.
Bozyaka Training and Research Hospital has 3 studies filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
29 of the studies in Osteoarthritis, Knee with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07887893Dokuz Eylul UniversityExtracorporeal Shock Wave Therapy in the Treatment of Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis | 2026-11-01 |
| NCT07381621Ankara Training and Research HospitalPerineural Dextrose Versus Local Anesthetic Injections in Knee Osteoarthritis | 2026-11-01 |
| NCT07767812Kutahya Health Sciences UniversityEffects of Motivational Interviewing on Pain Self-Efficacy and Exercise Behavior in Individuals With Knee Osteoarthritis | 2026-11-15 |
| NCT07678996Kayseri City HospitalDose-Response Effect of Intra-Articular Ozone in Knee Osteoarthritis | 2026-11-30 |
| NCT06430918Bozyaka Training and Research HospitalNeuropathic Pain and it's Relation to Sleep Quality in Knee Osteoarthritis | 2026-12-01 |
Among the 268 studies in Osteoarthritis, Knee with a site in Turkey, from their registry updates:
The primary aim is to investigate the frequency and severity of neuropathic pain and its association with night pain in patients with knee osteoarthritis. For this purpose a progressive longitudinal study design was planned. The secondary aim is to investigate the relationship between night pain and neuropathic pain and sleep quality.
Osteoarthritis (OA) is the most common form of arthritis in the world. Classically, OA presents with joint pain and loss of function; however, the disease is clinically very variable and can present merely as an asymptomatic incidental finding to a devastating and permanently disabling disorder.
The severity of knee pain caused by osteoarthritis, often does not correlate with the degree of degenerative changes in the joint. In patients reporting night pain, this may be related to inflammation, but in the absence of clinical and laboratory findings of inflammation, it is not possible to explain night pain only by the degree of joint damage. The existence of a relationship between night pain and neuropathic pain may be a guide in looking for neuropathic pain in patients who have night pain and experience this pain severely and thus for planning an appropriate treatment for the patient.
Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form. The relationship between neuropathic pain scores and knee pain severity will be sought. It will be studied whether there is a difference in outcome measurement parameters between those with neuropathic pain and those without. Correlation analysis will be performed between sleep quality score and pain intensity scores. The determinants of sleep quality will be evaluated by regression analysis.
American College of Rheumatology criteria will be recruited. Demographics and disease related variables will be recorded.
Patients with stage 2-4 knee OA will be evaluated in terms of demographic variables and outcome measurement parameters specified in the case report form.
Inclusion Criteria:
1. Having a clinical diagnosis of knee osteoarthritis according to the American Rheumatology Association/ACR criteria 2. Knee OA is of Kellgren-Lawrence stage 2-4 3. The participant gives signed consent
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Exclusion Criteria:
Exclusion Criteria:
1. Having diabetes mellitus 2. Chronic kidney failure 3. Hypothyroidism 4. Presence of orthopedic disability (such as implant, prosthesis, contracture, shortness) in the lower extremity 4. Neurological diseases that can cause neuropathic pain 5. Presence of fibromyalgia 6. 7. Pregnancy 8. Neurological deficit in the lower extremity 9. Drug use that may cause neuropathy (colchicine, etc.) İn the last 3 months 10. Drug use (antidepressant, antipsychotic, antiepileptic) due to sleep disturbance or widespread pain in the last 3 months.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Knee OA patients diagnosed according to the ACR Classification Criteria
Other: physical examination, questionnaires and inventories
Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
Also known as: Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire
The DN4 questionnaire (4 Questions Neuropathic Pain Questionnaire) will be used. It is a clinician-administered questionnaire. It consists of ten items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient. Three items are based on the clinical examination. The clinician assesses whether there is reduced sensation (hyposthesia) to touch or pinprick and whether light brushing increases or causes pain (allodynia). All of the positive items are scored as one point and total score is sum of the scores of these positive items. The diagnosis is based on 4/10 cut-off value.
Time frame: through study completion, an average of 1 year
Sleep quality
Jenkins Sleep Scale.The four-item questionnaire evaluates the frequency and intensity of certain sleep difficulties in respondents. Questions queries the number of days in which the patient was subjected to sleep problems. The maximum possible score is 20 and higher scores indicate much more sleep disturbance. A mean score of two or more is considered as sleep disturbance presence.
Time frame: through study completion, an average of 1 year
Depression and Anxiety; The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) was developed by Zigmond and Snaith in 1983. It is used to detect whether the patient is in the depressive or anxious status. It is not a diagnostic tool but gives to physician an idea about the patient's emotional status. It consists of fourteen items. Seven items are related to anxiety and the other seven depression
Time frame: through study completion, an average of 1 year
Quality of life level; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Quality of Life" subgroup
KOOS evaluates the symptoms and functional problems related to knee OA and knee injury. It consists of five subscales. In this study authors intended to assess the life quality by using the quality of life level subscale of this scale.
Time frame: through study completion, an average of 1 year
Disability; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Activities of Daily Life and Function" subgroup
Disability; KOOS (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) "Activities of Daily Life and Function" subgroup
Time frame: through study completion, an average of 1 year
Night pain (VAS, 0-10 cm) Participants will be asked to report the pain intensity that they feel on a line between 0 and 10, higher scores indicating more intense pain.
Participants will be asked to report the pain intensity that they feel on a line between 0 and 10, higher scores indicating more intense pain.
Time frame: through study completion, an average of 1 year
Started May 2024 (actual). Primary completion is estimated for Dec 2026, 30 months after the start.
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Bozyaka Training and Research Hospital