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

18 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

81

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Rheumatoid Arthritis Patients
SARAH Exercise
Autre: 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.
Expérimental: Rheumatoid Arthritis Patients with Central Sensitization1
SARAH Exercise
Autre: 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.
Expérimental: Rheumatoid Arthritis Patients with Central Sensitization2
SARAH Exercise + Desensitization Exercises
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
VAS
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fulya Coşkun

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 août 2025

Achèvement primaire (Réel)

22 décembre 2025

Achèvement de l'étude (Estimé)

22 juin 2026

Dates d'inscription aux études

Première soumission

12 mai 2026

Première soumission répondant aux critères de contrôle qualité

18 mai 2026

Première publication (Réel)

20 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2024KAEK18-5048

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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