Clinical trial NCT06739096: Investigation of the Effectiveness of Short Wave Diathermy Treatment in Patients with Hand Osteoarthritis
Official title: Investigation of the Effectiveness of Short Wave Diathermy Treatment in Patients with Hand Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Osteoarthritis
Osteoarthritis
Keywords: hand osteoarthritis
short wave diathermy
shortwave diathermy
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
measure: hand dynamometer and pinchmeter measurements
timeFrame: 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:
measure: Duruöz Hand Index
timeFrame: At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
measure: Moberg Pickup Test
timeFrame: At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Haydarpaşa Numune Training and Research Hospital
Study officials:
affiliation: Haydarpaşa Numune Training and Research Hospital
name: Nilgün Mesci, Assoc. Prof., MD
role: STUDY_CHAIR
affiliation: Haydarpaşa Numune Training and Research Hospital
name: Duygu Geler Külcü, Prof., MD
role: STUDY_DIRECTOR
affiliation: Haydarpaşa Numune Training and Research Hospital
name: Sibel Süzen Özbayrak, MD
role: STUDY_DIRECTOR
References: