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

NCT07598240 | Active Not Recruiting

• 1 other identifier: 2024KAEK18-5048
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hand Exercises for Rheumatoid Arthritis

Keywords

rheumatoid arthritis; central sensitization; hand exercise

Outcome Measures

Primary Outcomes (5)

• VAS

  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

  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

  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)

  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)

  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.

Study Arms (3)

Rheumatoid Arthritis Patients

EXPERIMENTAL

SARAH Exercise

Other: Exercise1

Rheumatoid Arthritis Patients with Central Sensitization1

EXPERIMENTAL

SARAH Exercise

Other: Exercise2

Rheumatoid Arthritis Patients with Central Sensitization2

EXPERIMENTAL

SARAH Exercise + Desensitization Exercises

Other: Exercise3

Interventions

Exercise1 OTHER

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.

Rheumatoid Arthritis Patients

Exercise2 OTHER

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.

Rheumatoid Arthritis Patients with Central Sensitization1

Exercise3 OTHER

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.

Rheumatoid Arthritis Patients with Central Sensitization2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fulya Coşkun: lead

Study Sites (1)

Haydarpaşa Numune Eğitim Ve Araştirma Hastanesi Validebağ Ek Hizmet Binasi

Istanbul, ÜSKÜDAR, 34674, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 38757102 BACKGROUND

• 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.

  PMID: 30063798 BACKGROUND

• 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.

  PMID: 37227116 BACKGROUND

Related Links

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: asistant doctor in physical medicine and rehabilitation

Model Details: Central sensitization is a state of increased neuronal sensitivity and synaptic plasticity in central pain pathways following painful stimulation. Central sensitization causes increased sensitivity of the central nervous system to painful and non-painful stimuli. Central sensitization has been reported in 15-40% of patients with inflammatory rheumatic diseases. The presence of central sensitization leads to overestimation of pain sensitivity and disease activity in rheumatoid arthritis 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.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 20, 2026
• Study Start: August 22, 2025
• Primary Completion: December 22, 2025
• Study Completion (Estimated): June 22, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

TU (1)