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

18. maj 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

81

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Rheumatoid Arthritis Patients
SARAH Exercise
Andet: 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.
Eksperimentel: Rheumatoid Arthritis Patients with Central Sensitization1
SARAH Exercise
Andet: 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.
Eksperimentel: Rheumatoid Arthritis Patients with Central Sensitization2
SARAH Exercise + Desensitization Exercises
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
VAS
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fulya Coşkun

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. august 2025

Primær færdiggørelse (Faktiske)

22. december 2025

Studieafslutning (Anslået)

22. juni 2026

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024KAEK18-5048

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