The Effectiveness of Dry Needling in Treating Linear Hypertrophic Scar Tissue: a Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Flexibility of the scar tissue (tissue compliance)
研究概览
简要总结
Scar tissue can cause serious complications that significantly impact a patient's quality of life. Common complications include stiffness and contractions, which can restrict joint mobility and make daily activities challenging. In severe cases, these limitations can even prevent patients from fulfilling their work responsibilities or engaging in activities they enjoy. The deleterious effect of scar tissue on a patient's well-being is of utmost significance. However, several therapeutic approaches have been proposed to manage scar tissue complications. Enhancing scar tissue compliance can help patients regain their functional abilities and reduce limitations. One such approach is dry needling, a technique used to improve the flexibility of myofascial tightness. Nevertheless, the effectiveness of dry needling in improving scar tissue compliance remains debatable. Therefore, this study aims to investigate the therapeutic effects of dry needling on complications resulting from linear hypertrophic scars caused by surgery or trauma.
详细描述
RESEARCH OBJECTIVE:
The primary objective of this study is to investigate the effectiveness of dry needling on hypertrophic scar tissue compliance using a compliance meter. The secondary objectives of the study are to evaluate active and passive range of motion, pain, and functional disability.
RESEARCH DESIGN:
This study is a two-centered, randomized, single-blind, sham-controlled trial with an allocation ratio of 1:1. Eighty participants with hypertrophic scar tissue will be randomly assigned into two groups with equal sample size. Random allocation will be performed using the permuted block randomization method, consisting of four-letter blocks made of letters A and B. The random treatment list obtained at the end of the random allocation task will be placed in letters A and B inside sealed and numbered envelopes. The random assignment process will be performed by someone outside the research team before the study begins.
PROCEDURE:
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
- Single (Participant)
盲法说明
Participants in the control group will undergo the same procedure as those in the intervention group, with needles placed superficially in an area slightly further away from the scar tissue. Furthermore, to minimize bias, the data analyst will be blinded to the grouping of the participants, and each participant will be identified by a unique numerical code.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Linear hypertrophic scar tissue with an age of more than six weeks
- •No restrictions on active and passive joint range of motion near the scar tissue
- •Age between 20 and 60 years
排除标准
- •Needle phobia
- •Immature scar or keloid scar
- •Skin diseases or infections near the scar tissue
- •Fractures that have altered joint mobility
- •Anticoagulant medication use
结局指标
主要结局
Flexibility of the scar tissue (tissue compliance)
时间窗: Change in flexibility of the scar tissue after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up
The Tissue Compliance Meter (STCM), created by the Technical University of Chemnitz in Germany, is a straightforward tool for measuring tissue compliance. It consists of a ruler with millimeter markings, attached to a standard algometer from Greenwich, CT, USA. It also includes two additional components: a round plastic disk with a metal cylinder and a ring with a screw for securing them in place. These disk and ring components can be adjusted along the ruler. A button cell battery is used to generate a beep when the ring and disk touch each other. To take a measurement, the investigator pushes the top of the algometer into the tissue until it reaches displacements of 0.5, 1, and 1.5 centimeters on the scar tissue. The investigator then records the applied force in either kilograms or Newtons, depending on the pre-set displacement. Each measurement is repeated three times, and the average of these three repetitions is used for statistical analysis.
次要结局
- Active and passive joint range of motion(Change in joint range of motion after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up)
- Pain intensity(Change in pain after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up)
- Health-related quality of life(Change in health status after the end of 6 treatment sessions compared to baseline and change from baseline at 2-week follow up)