- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07598240
Is a Standard Hand Rehabilitation Program Sufficient in Rheumatoid Arthritis Patients With Central Sensitization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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ÜSKÜDAR
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Istanbul, ÜSKÜDAR, Turkey (Türkiye), 34674
- Haydarpaşa Numune Eğitim Ve Araştirma Hastanesi Validebağ Ek Hizmet Binasi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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:
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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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Rheumatoid Arthritis Patients
SARAH Exercise
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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.
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Experimental: Rheumatoid Arthritis Patients with Central Sensitization1
SARAH Exercise
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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.
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|
Experimental: Rheumatoid Arthritis Patients with Central Sensitization2
SARAH Exercise + Desensitization Exercises
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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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.
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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
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Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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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.
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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.
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Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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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.
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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).
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Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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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.
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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).
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Assessments will be conducted at baseline, at the end of the 3-month exercise program, and at the 6-month follow-up.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024KAEK18-5048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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