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Investigation of the Effectiveness of Short Wave Diathermy Treatment in Patients with Hand Osteoarthritis

NCT ID: NCT06739096

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2025-05-18

Brief Summary

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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

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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

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Hand Osteoarthritis Osteoarthritis

Keywords

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hand osteoarthritis short wave diathermy shortwave diathermy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Short Wave Diathermy + Exercise

Group Type EXPERIMENTAL

Short Wave Diathermy

Intervention Type DEVICE

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.

Exercise

Intervention Type OTHER

range of motion, strengthening and stretching exercises

Sham Short Wave Diathermy + Exercise

Group Type SHAM_COMPARATOR

Exercise

Intervention Type OTHER

range of motion, strengthening and stretching exercises

Sham Short Wave Diathermy

Intervention Type DEVICE

Sham protocol

Interventions

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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.

Intervention Type DEVICE

Exercise

range of motion, strengthening and stretching exercises

Intervention Type OTHER

Sham Short Wave Diathermy

Sham protocol

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Omer Sezgin

OTHER

Sponsor Role lead

Responsible Party

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Omer Sezgin

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nilgün Mesci, Assoc. Prof., MD

Role: STUDY_CHAIR

Haydarpaşa Numune Training and Research Hospital

Duygu Geler Külcü, Prof., MD

Role: STUDY_DIRECTOR

Haydarpaşa Numune Training and Research Hospital

Sibel Süzen Özbayrak, MD

Role: STUDY_DIRECTOR

Haydarpaşa Numune Training and Research Hospital

Locations

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Haydarpaşa Numune Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ömer Sezgin, MD

Role: CONTACT

Phone: +90535428075

Email: [email protected]

Nilgün Mesci, Assoc. Prof., MD

Role: CONTACT

Phone: +905336295998

Email: [email protected]

Facility Contacts

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Ömer Sezgin, MD

Role: primary

Other Identifiers

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HNHEAH-KAEK 2024/36

Identifier Type: -

Identifier Source: org_study_id