Neuropathic Pain and it's Relation to Sleep Quality in Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: physical examination, questionnaires and inventories.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis, Sleep Disturbance, Neuropathic Pain. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Coexistence of Night Pain and Neuropathic Pain in Patients With Knee Osteoarthritis
Overview
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.
Detailed description
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.
Interventions
- Other physical examination, questionnaires and inventories
Questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
Primary outcome measures
- Neuropathic pain; 4 Questions Neuropathic Pain Questionnaire [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (5)
- Sleep quality [Time frame: through study completion, an average of 1 year]
- Depression and Anxiety; The Hospital Anxiety and Depression Scale (HADS) [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 [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 [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. [Time frame: through study completion, an average of 1 year]
Eligibility criteria
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. Malignancy 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Turkey (Türkiye) · 1 center
- Izmir Bozyaka Training and Reseach Hospital — Izmir
Publications
- Hoper J, Schraml L, Gierthmuhlen J, Helfert SM, Rehm S, Hartig S, Schroder O, Lankes M, Traulsen FC, Seekamp A, Baron R. Changes of Somatosensory Phenotype in the Course of Disease in Osteoarthritis Patients. Int J Environ Res Public Health. 2020 Apr 29;17(9):3085. doi: 10.3390/ijerph17093085. PMID 32365479
- Wylde V, Palmer S, Learmonth ID, Dieppe P. Somatosensory abnormalities in knee OA. Rheumatology (Oxford). 2012 Mar;51(3):535-43. doi: 10.1093/rheumatology/ker343. Epub 2011 Nov 24. PMID 22120461
Identifiers
NCT: NCT06430918 · 226092BK