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Is a Standard Hand Rehabilitation Program Sufficient in Rheumatoid Arthritis Patients With Central Sensitization

18 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

81

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
    • ÜSKÜDAR
      • Istanbul, ÜSKÜDAR, Turkije (Türkiye), 34674
        • Haydarpaşa Numune Eğitim Ve Araştirma Hastanesi Validebağ Ek Hizmet Binasi

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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:

-

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Rheumatoid Arthritis Patients
SARAH Exercise
Ander: Exercise1
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.
Experimenteel: Rheumatoid Arthritis Patients with Central Sensitization1
SARAH Exercise
Ander: Exercise2
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.
Experimenteel: Rheumatoid Arthritis Patients with Central Sensitization2
SARAH Exercise + Desensitization Exercises
Ander: Exercise3
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
VAS
Tijdsspanne: Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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.
Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
CENTRAL DESENSİTİZATİON SCALE
Tijdsspanne: Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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
Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
DURUOZ HAND INDEX
Tijdsspanne: Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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.
Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
Dynamometer-measured hand grip strength measurements (kg)
Tijdsspanne: Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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).
Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
Pinchmeter-measured finger strength measurements (kg) (Tip, Lateral, Palmar)
Tijdsspanne: Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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).
Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fulya Coşkun

Publicaties en nuttige links

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Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 augustus 2025

Primaire voltooiing (Werkelijk)

22 december 2025

Studie voltooiing (Geschat)

22 juni 2026

Studieregistratiedata

Eerst ingediend

12 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 mei 2026

Eerst geplaatst (Werkelijk)

20 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

18 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2024KAEK18-5048

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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