Hand OsteoarthritisNCT06739096
Investigation of the Effectiveness of Short Wave Diathermy Treatment in Patients With Hand Osteoarthritis
A study testing Short Wave Diathermy and Exercise in people with Hand Osteoarthritis and Osteoarthritis, run by Omer Sezgin at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hand Osteoarthritis, Osteoarthritis
- What is being tested?
- Short Wave Diathermy and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be between 35-75 years old
- Diagnosis of hand osteoarthritis according to the ACR 1990 Criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpaşa Numune Training and Research Hospital
Istanbul, Istanbul, 34668
About this study
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.
Read the 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.
- Conditions
- Hand Osteoarthritis, Osteoarthritis
- Being tested
- Short Wave Diathermy, Exercise, Sham Short Wave Diathermy
- Keywords
- hand osteoarthritis, short wave diathermy, shortwave diathermy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Wave DiathermyDevice
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.
ExerciseOther
range of motion, strengthening and stretching exercises
Sham Short Wave DiathermyDevice
Sham protocol
| Study group | Role | What they receive |
|---|---|---|
| Short Wave Diathermy + Exercise | Experimental | Not described Receives: Device: Short Wave Diathermy; Other: Exercise |
| Sham Short Wave Diathermy + Exercise | Sham comparator | Not described Receives: Other: Exercise; Device: Sham Short Wave Diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
0-10 scale. Higher scores represent more severe pain.
Measured: 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
Measurements will be made three times for each fine force on both hands and the average values will be recorded in kg.
Measured: 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 outcomes (2)
Duruöz Hand Index
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.
Measured: 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
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.
Measured: At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start18 Mar 2024
- Primary completion18 Feb 2025
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omer Sezgin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omer Sezgin, Haydarpasa Numune Training and Research Hospital
- Investigators
- Nilgün Mesci, Assoc. Prof., MD, Study chair, Haydarpaşa Numune Training and Research HospitalDuygu Geler Külcü, Prof., MD, Study director, Haydarpaşa Numune Training and Research HospitalSibel Süzen Özbayrak, MD, Study director, Haydarpaşa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739096
- Sponsor's protocol ID
- HNHEAH-KAEK 2024/36
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Safety concerns
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Short Wave Diathermy Treatment in Patients With Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT06739096
- Acronym / sponsor ID
- HNHEAH-KAEK 2024/36
- Conditions
- Hand Osteoarthritis, Osteoarthritis
- Keywords
- hand osteoarthritis, short wave diathermy, shortwave diathermy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Omer SezginUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Wave Diathermy + Exercise | Experimental | Device: Short Wave Diathermy, Other: Exercise |
| Sham Short Wave Diathermy + Exercise | Sham comparator | Other: Exercise, Device: Sham Short Wave Diathermy |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be between 35-75 years old
- Diagnosis of hand osteoarthritis according to the ACR 1990 Criteria
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Wave DiathermyShortwave 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. | Device | Short Wave Diathermy + Exercise |
| Exerciserange of motion, strengthening and stretching exercises | Other | Sham Short Wave Diathermy + Exercise, Short Wave Diathermy + Exercise |
| Sham Short Wave DiathermySham protocol | Device | Sham Short Wave Diathermy + Exercise |
Primary outcome
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.
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.
2 secondary outcomes
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No. Safety concerns
Related trials for Hand Osteoarthritis
Active, not recruiting
Balneotherapy in Hand Osteoarthritis
Hand Osteoarthritis
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Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Hand Osteoarthritis, Erosive Osteoarthritis
Active, not recruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Osteoarthritis Hand
RecruitingPhase 2/3
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Erosive Hand Osteoarthritis
Recruiting
Acupuncture vs Sham Acupuncture for Hand Osteoarthritis
Hand Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilgün Mesci, Assoc. Prof., MD study chair
Haydarpaşa Numune Training and Research Hospital
Duygu Geler Külcü, Prof., MD study director
Haydarpaşa Numune Training and Research Hospital
Sibel Süzen Özbayrak, MD study director
Haydarpaşa Numune Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Wave Diathermy and Exercise in people with Hand Osteoarthritis and Osteoarthritis, run by Omer Sezgin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.