Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07598240

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Hand Exercises for Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haydarpaşa Numune Eğitim Ve Araştirma Hastanesi Validebağ Ek Hizmet Binasi

Istanbul, ÜSKÜDAR, 34674, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. VAS

    Time frame: 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.

  2. CENTRAL DESENSİTİZATİON SCALE

    Time frame: 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

  3. DURUOZ HAND INDEX

    Time frame: 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.

  4. Dynamometer-measured hand grip strength measurements (kg)

    Time frame: 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).

  5. Pinchmeter-measured finger strength measurements (kg) (Tip, Lateral, Palmar)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Fulya Coşkun

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.