- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06739096
Investigation of the Effectiveness of Short Wave Diathermy Treatment in Patients With Hand Osteoarthritis
November 19, 2025 updated by: Omer Sezgin
The aim of this randomized, double-blind, placebo-controlled study was to evaluate the effects of shortwave diathermy therapy on pain, grip strength, and functionality in patients with hand osteoarthritis.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients who apply to the physical medicine and rehabilitation outpatient clinic between January 2024 and February 2025 will be included in the study according to the inclusion and exclusion criteria specified below.
Demographic data of the patients such as age, gender, height, and weight will be recorded.
In the initial evaluation, VAS, hand dynamometer and pinchmeter measurements, Duruöz Hand Index questionnaire and Moberg Addition Test results of the patients will be noted.
The G*Power 3.1 (Faul, Erdfelder, Lang, and Buchner, 2007) program was used to calculate the sample size.
In the comparisons of different parameters between groups in reference studies, the effect size was calculated to be at the level of 0.9.
This corresponds to a large level according to Cohen's effect size classification.
Accepting a statistical significance coefficient of 0.05 with an effect size of 0.9, it was decided to include a minimum of 16 people in each group to obtain 80% power.
A total of 36 patients (with a 10% drop-out margin) will be included in the study and will be randomly divided into two groups as treatment and control groups.
Randomization will be done by closed envelope method.
The treatment group will be given 15 sessions: 20 minutes (27.12 MHz, continuous mode, 400W output) short wave diathermy treatment, hand osteoarthritis exercise program.
The control group will be given 15 sessions: sham short wave diathermy and hand osteoarthritis exercise program.
Patients will complete 15 sessions, 1 session per day, 5 sessions per week.
All evaluation parameters will be recorded before treatment, at the end of treatment and at the end of treatment at the 12th week.
Intra-group and inter-group differences will be examined statistically.
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34668
- Haydarpasa Numune Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- To be between 35-75 years old
- Diagnosis of hand osteoarthritis according to the ACR 1990 Criteria
Exclusion Criteria:
- Chronic inflammatory diseases (rheumatoid arthritis, seronegative spondyloarthropathy, gout, hemochramatosis, etc.)
- Malignancy
- Having uncontrolled systemic disease (cardiovascular, pulmonary, hematologic, hepatic, renal, endocrinologic)
- Synovitis, tenosynovitis, entrapment neuropathy, contracture, open wound in hand/wrist
- History of hand fracture and/or operation
- Regular use of nonsteroidal anti-inflammatory drugs in the last three weeks
- Regular use of diaserin, chondroitin sulfate, glucosamine in the last three months
- Body Mass Index greater than 35
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Short Wave Diathermy + Exercise
|
Shortwave diathermy (SWT) is a form of electromagnetic therapy that causes the movement of ions, the disruption of molecules, and the generation of eddy currents, which ultimately produce heat in deep tissue.
Its claimed mechanism of action includes inducing an anti-inflammatory response, reducing joint stiffness, stimulating connective tissue repair, and reducing muscle spasm and pain.
range of motion, strengthening and stretching exercises
|
|
Sham Comparator: Sham Short Wave Diathermy + Exercise
|
range of motion, strengthening and stretching exercises
Sham protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
|
0-10 scale.
Higher scores represent more severe pain.
|
At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
|
|
hand dynamometer and pinchmeter measurements
Time Frame: At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
|
Measurements will be made three times for each fine force on both hands and the average values will be recorded in kg.
|
At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duruöz Hand Index
Time Frame: At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
|
It is a self-report functional disability scale containing 18 items on daily living activities.
Each question is scoring from 0 to 5. The total score ranges from 0 to 90.
A higher score indicates a greater level of limitations.
|
At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
|
|
Moberg Pickup Test
Time Frame: At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
|
In the Moberg pick-up test, for the evaluation of hand skills, the patient was positioned in the sitting position in a chair and a table was put in front of the patient, and 8 small objects were put on the table .
The patient was requested to pick up these objects using the affected hand without sliding on the surface and to put them in a box present on the table, and the duration was recorded in seconds.
|
At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Nilgün Mesci, Assoc. Prof., MD, Haydarpasa Numune Training and Research Hospital
- Study Director: Duygu Geler Külcü, Prof., MD, Haydarpasa Numune Training and Research Hospital
- Study Director: Sibel Süzen Özbayrak, MD, Haydarpasa Numune Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2024
Primary Completion (Actual)
February 18, 2025
Study Completion (Estimated)
February 28, 2026
Study Registration Dates
First Submitted
December 8, 2024
First Submitted That Met QC Criteria
December 12, 2024
First Posted (Actual)
December 18, 2024
Study Record Updates
Last Update Posted (Actual)
November 26, 2025
Last Update Submitted That Met QC Criteria
November 19, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HNHEAH-KAEK 2024/36
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Safety concerns
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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