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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Short Wave Diathermy + Exercise
Device: Short Wave Diathermy
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.
Other: Exercise
range of motion, strengthening and stretching exercises
Sham Comparator: Sham Short Wave Diathermy + Exercise
Other: Exercise
range of motion, strengthening and stretching exercises
Device: Sham Short Wave Diathermy
Sham protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Omer Sezgin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 18, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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