Extracorporeal Shock Wave Versus Photobiomodulation Therapy for Chronic Ankle Instability
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Thickness of ligament in patients with chronic ankle instability.
研究概览
简要总结
PURPOSE:
To Compare between the effect of extra corporeal shock wave and Photobiomodulation on pain level, ROM, muscle strength, function level, dynamic balance and thickness of ligament in patients with chronic ankle instability.
BACKGROUND:
Lateral ankle sprains are the most common lower limb musculoskeletal injury incurred by individuals who participate in sports and recreational physical activities Approximately 40% of individuals who sustain a LAS develop a condition known as chronic ankle instability (CAI) (Miklovic et al., 2018), The lateral ligamentous complex is the main structure affected in 80-85% of these injuries, which are originated from a sudden inversion or supination trauma (Mansur et al., 2021).
The ligament system plays a fundamental role in the ankle's stability and includes a talocrural complex and a subtalar complex that are functionally related. For the talocrural joint, three lateral collateral ligaments are present and one medial collateral ligament (Bonnel et al., 2010).
Physical examination is mostly the first diagnostic step in the assessment of ankle injuries. Imaging modalities such as ultrasonography (US) and magnetic resonance imaging (MRI) play a major role in providing a detailed depiction of ankle tendons and ligaments (Hosseinian et al., 2022).
The effect of ESWT is Higher multiplication of collagen fibers; faster organization of muscle fibers and vascularization by treatment with radial shockwaves (Schnurrer-Luke-Vrbanic et al., 2018), ESWT could improve pain, ankle instability, ankle function, dorsiflexion ROM, and dynamic balance in patients with CAI (Le et al., 2022).
Photobiomodulation Therapy (PBMT) is effective for patients with an ankle sprain. PBMT showed high effect size with a moderate level of evidence on pain intensity and is related to the PBMT intensity and frequency (Alayat et al., 2024).
HYPOTHESES:
There is no statistically significant effect of extra corporeal shock wave versus photobiomodulation on level of pain, ROM, muscle strength, function level, dynamic balance and thickness of ligament in patients with chronic ankle instability.
RESEARCH QUESTION:
Is there any effect of extra corporeal shock wave versus Photobiomodulation on pain level, ROM, muscle strength, function level, dynamic balance and thickness of ligament in patients with chronic ankle instability?
详细描述
The purpose of the study will be to investigate the effect of extracorporeal shock wave versus photobiomodulation therapy for chronic ankle instability Design of the study: A pre and posttest randomized controlled trial.
Subjects of the study:
participants will be chosen according to inclusive criteria. The sample size will be calculated depending on pilot study by power analysis (G power).
Group A: will receive exercise program include (Resistance Band Protocols, Resistance Kinematic Chain Exercises, Heel raise and Balance Exercise) at painful ankle.
Group B: as group A, plus the extra corporeal shock wave. Group C: as group A, plus the photobiomodulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 participants ranging in age from 18 to 65 years from both gender with a diagnosis of Chronic lateral ankle instability stage (II) (Schurz et al., 2023).
- •Patients body mass index (BMI) are ranged from 18,5 to 25 (lee et al., 2022). The main presenting symptoms were ankle pain with restricted ROM that compromised activities of daily living (Schurz et al., 2023).
- •All ankle sprains occurring more than four weeks before inclusion both recurrent sprain and CAI patients are included (Schurz et al., 2023).
- •Mild to moderate severity of pain measured by NPRS scale (Srinivas, 2022). no wounds in the ankle joint and calf (lee et al., 2022). Participants had no history of ankle joint injuries or surgical procedures within the last year and injection treatment around the ankle joint within six months (lee et al., 2022).
排除标准
- •they had any medical condition that could cause ankle pain (arthritis, fracture, rheumatiod arthritis, any deformity of ankle and neurological condition).
- •Any individual who had previously suffered a musculoskeletal injury or surgery that could have influenced the measurement was also eliminated.
- •Any individual who had diagnosed a Chronic lateral ankle instability stage (I, III).
- •Acute foot trauma occurring from 7 days of injury (Srinivas, 2022).
研究组 & 干预措施
Exercise Program
articipants receive a supervised therapeutic exercise program (strengthening, stretching, balance/proprioception). Standard care allowed.
干预措施: therapeutic exercise program (Behavioral)
Exercise Program
articipants receive a supervised therapeutic exercise program (strengthening, stretching, balance/proprioception). Standard care allowed.
干预措施: Extra corporeal shock wave therapy (Device)
Exercise Program
articipants receive a supervised therapeutic exercise program (strengthening, stretching, balance/proprioception). Standard care allowed.
干预措施: photobiomodulation Therapy (Device)
ESWT
participants will receive Extracorporeal Shock Wave Therapy (ESWT) in addition to standard care.
干预措施: Extra corporeal shock wave therapy (Device)
Photobiomodulation
Participants receive photobiomodulation therapy (low-level laser/LED) in addition to standard care.
干预措施: photobiomodulation Therapy (Device)
结局指标
主要结局
Thickness of ligament in patients with chronic ankle instability.
时间窗: Before and after treatment program for 1 month
Thickness of ligaments (lateral ligaments) measure by sonography that done according to European Society of Musculoskeletal Radiology (ESSR) guidelines by an experienced radiologist
Function activity level
时间窗: Before and after treatment program for 1 month
The Arabic version of the IdFAI (IdFAI-Ar) questionnaire is effectively translated and cross-culturally adapted. It is valid, reliable, accurate, specific, and sensitive tool to determine ankle stability status. It obtained excellent reliability and strong validity to identify patients with FAI in both clinical practice and research
次要结局
- pain assessment:(Before and after treatment program for 1 month)
- Ankle joint range of motion(Before and after treatment program for 1 month)
研究者
Dina Ramadan Ahmed
Assistant lecture
Cairo University