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

18 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Activo, no reclutando

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

81

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Rheumatoid Arthritis Patients
SARAH Exercise
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.
Experimental: Rheumatoid Arthritis Patients with Central Sensitization1
SARAH Exercise
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.
Experimental: Rheumatoid Arthritis Patients with Central Sensitization2
SARAH Exercise + Desensitization Exercises
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
VAS
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de agosto de 2025

Finalización primaria (Actual)

22 de diciembre de 2025

Finalización del estudio (Estimado)

22 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2026

Publicado por primera vez (Actual)

20 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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