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临床试验/NCT06739096
NCT06739096进行中(未招募)不适用

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

Omer Sezgin1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
36
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be between 35-75 years old
  • Diagnosis of hand osteoarthritis according to the ACR 1990 Criteria

排除标准

  • 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

结局指标

主要结局

Visual Analog Scale

时间窗: 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

时间窗: 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.

次要结局

  • Duruöz Hand Index(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(At the beginning of treatment (week 0), at the end of treatment (week 3) and 12 weeks after the end of treatment (week 15))

研究者

发起方
Omer Sezgin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Omer Sezgin

MD

Haydarpasa Numune Training and Research Hospital

研究点 (1)

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