Is a Standard Hand Rehabilitation Program Sufficient in Rheumatoid Arthritis Patients With Central Sensitization
18 maja 2026 zaktualizowane przez: Fulya Coşkun
The presence of central sensitization leads to overestimation of pain sensitivity and disease activity in rheumatoid arthritis (RA) patients.
Central sensitization should not be overlooked in RA patients to avoid over-treatment for inflammation and to determine the need for treatment of nociplastic pain.
While literature contains no studies comparing alternative programs with the standard hand rehabilitation program in the presence of central sensitization in rheumatoid arthritis patients, the objective of this study is to investigate whether desensitization exercises provide additional benefit in this patient group.
Przegląd badań
Status
Aktywny, nie rekrutujący
Interwencja / Leczenie
Szczegółowy opis
The study is designed prospectively and will be conducted between August 22, 2025, and June 22, 2026. Patients who are regularly followed in the Physical Medicine and Rehabilitation rheumatology outpatient clinic of Haydarpasa Numune Training and Research Hospital and who meet the inclusion and exclusion criteria will be included. Demographic data such as age, height, weight, waist circumference, and diet type of participants will be recorded. At baseline, the Central Sensitization Scale, Rheumatoid Arthritis Quality of Life Scale, RA Articular Damage Score, Health Assessment Questionnaire, and Duruöz Hand Index questionnaires will be administered. DAS28 and ACR50 responses will be noted. Sedimentation and CRP values from routine follow-up files, as well as hand dynamometry and pinchmeter (lateral, palmar, and fingertip) grip strengths, will be recorded.
The study consists of one group of rheumatoid arthritis patients and two groups of rheumatoid arthritis patients with accompanying central sensitization. Group 1 (Rheumatoid Arthritis Patients) and Group 2 (Rheumatoid Arthritis Patients with Central Sensitization) will be taught determined strengthening and mobility exercises under the supervision of a physiotherapist to ensure correct home application. The investigator will also provide recorded exercise videos and handouts for patients. Group 3 (RA Patients with Central Sensitization) will additionally perform desensitization exercises 7 days a week for 3 months, in addition to the strengthening and mobility exercises. Randomization will be conducted using the sealed envelope method. Patient compliance with the exercise program will be monitored by the investigator via telephone contact on specific days of the week.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
81
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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ÜSKÜDAR
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Istanbul, ÜSKÜDAR, Turcja (Türkiye), 34674
- Haydarpaşa Numune Eğitim Ve Araştirma Hastanesi Validebağ Ek Hizmet Binasi
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion *Rheumatoid Arthritis Group Without Central Sensitization (Group 1):
- Being between 18-75 years of age
- Not having had upper extremity surgery within the last 1 year
- Patients without active arthritis
- No change in medical treatment in the last 3 months
Having mild-moderate disease activity according to DAS28
*Rheumatoid Arthritis Group with Central Sensitization (Group 2):
- Being between 18-75 years of age
- Not having had upper extremity surgery within the last 1 year
- Patients without active arthritis
- No change in medical treatment in the last 3 months
Having mild-moderate disease activity according to DAS28
*Rheumatoid Arthritis Group with Central Sensitization (Group 3):
- Being between 18-75 years of age
- Not having had upper extremity surgery within the last 1 year
- Patients without active arthritis
- No change in medical treatment in the last 3 months
- Having mild-moderate disease activity according to DAS28
Criteria:
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Exclusion Criteria:
- Having had surgery on the extremity to be treated within the last 6 months
- Patients with active arthritis
- Patients with cognitive deficit
- Patients who do not consent to participate in the study
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Rheumatoid Arthritis Patients
SARAH Exercise
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Participants will be asked to practice home exercises every day of the week for 12 weeks.
The SARAH exercise program consists of 7 mobility and 4 strengthening exercises.
Progress will be made by increasing the repetitions and duration of the exercises every week.
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Eksperymentalny: Rheumatoid Arthritis Patients with Central Sensitization1
SARAH Exercise
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Participants will be asked to practice home exercises every day of the week for 12 weeks.
The SARAH exercise program consists of 7 mobility and 4 strengthening exercises.
Progress will be made by increasing the repetitions and duration of the exercises every week.
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Eksperymentalny: Rheumatoid Arthritis Patients with Central Sensitization2
SARAH Exercise + Desensitization Exercises
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Participants will be asked to practice home exercises every day of the week for 12 weeks.
The SARAH exercise program consists of 7 mobility and 4 strengthening exercises.
In addition to the strengthening and mobility exercises, participants will also perform desensitization exercises 7 days a week for 3 months.
Progress will be made by increasing the repetitions and duration of the exercises every week.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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VAS
Ramy czasowe: Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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The Visual Analog Scale (VAS) is used to assess pain intensity.
Scores range from 0 to 10, where 0 represents "no pain" and 10 represents "the worst possible pain."
Lower scores indicate a better clinical outcome.
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Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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CENTRAL DESENSİTİZATİON SCALE
Ramy czasowe: Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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Participants were categorized based on their Central Sensitization Inventory (CSI) scores, which range from 0 (no symptoms) to 100 (extreme symptoms).
A clinical threshold was set at 40; participants scoring 40 or higher were identified as meeting the criteria for central sensitization
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Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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DURUOZ HAND INDEX
Ramy czasowe: Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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Participants achieved a functional response based on the Duruöz Hand Index (DHI), which ranges from 0 (best outcome) to 90 (worst outcome).
A response was defined as a significant reduction in the total score from baseline, where lower scores indicate improved hand function and independence in daily activities.
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Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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Dynamometer-measured hand grip strength measurements (kg)
Ramy czasowe: Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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Hand grip strength was measured using a calibrated dynamometer to assess isometric muscle strength.
Results are reported in kilograms (kg).
On this scale, higher values indicate greater muscle strength and better physical performance (best outcome), while lower values indicate reduced grip strength (worst outcome).
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Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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Pinchmeter-measured finger strength measurements (kg) (Tip, Lateral, Palmar)
Ramy czasowe: Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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Finger pinch strength was measured using a calibrated pinchmeter to evaluate fine motor strength in three positions: Tip pinch (thumb to index finger), Lateral pinch (thumb to the radial side of the index finger), and Palmar pinch (thumb to index and middle fingers).
Measurements are recorded in kilograms (kg).
Higher values indicate greater functional strength and better hand performance (best outcome), whereas lower values indicate reduced pinch force (worst outcome).
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Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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Współpracownicy i badacze
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Sponsor
Publikacje i pomocne linki
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Publikacje ogólne
- Williams MA, Srikesavan C, Heine PJ, Bruce J, Brosseau L, Hoxey-Thomas N, Lamb SE. Exercise for rheumatoid arthritis of the hand. Cochrane Database Syst Rev. 2018 Jul 31;7(7):CD003832. doi: 10.1002/14651858.CD003832.pub3.
- England BR, Smith BJ, Baker NA, Barton JL, Oatis CA, Guyatt G, Anandarajah A, Carandang K, Chan KK, Constien D, Davidson E, Dodge CV, Bemis-Dougherty A, Everett S, Fisher N, Fraenkel L, Goodman SM, Lewis J, Menzies V, Moreland LW, Navarro-Millan I, Patterson S, Phillips LR, Shah N, Singh N, White D, AlHeresh R, Barbour KE, Bye T, Guglielmo D, Haberman R, Johnson T, Kleiner A, Lane CY, Li LC, Master H, Pinto D, Poole JL, Steinbarger K, Sztubinski D, Thoma L, Tsaltskan V, Turgunbaev M, Wells C, Turner AS, Treadwell JR. 2022 American College of Rheumatology Guideline for Exercise, Rehabilitation, Diet, and Additional Integrative Interventions for Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2023 Aug;75(8):1603-1615. doi: 10.1002/acr.25117. Epub 2023 May 25.
- Mesci N, Mesci E, Kandemir EU, Kulcu DG, Celik T. Impact of central sensitization on clinical parameters in patients with rheumatoid arthritis. North Clin Istanb. 2024 Apr 22;11(2):140-146. doi: 10.14744/nci.2023.81231. eCollection 2024.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
22 sierpnia 2025
Zakończenie podstawowe (Rzeczywisty)
22 grudnia 2025
Ukończenie studiów (Szacowany)
22 czerwca 2026
Daty rejestracji na studia
Pierwszy przesłany
12 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
18 maja 2026
Pierwszy wysłany (Rzeczywisty)
20 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
20 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2024KAEK18-5048
Plan dla danych uczestnika indywidualnego (IPD)
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NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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