Effectiveness of Myofascial Release in Patients With Chronic Post Sternotomy Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
The main aim of this study is to investigate the effectiveness of Myofascial release in patients with chronic sternotomy pain.
详细描述
Post-sternotomy pain syndrome (PSPS) is a prevalent disorder affecting a substantial proportion of patients who have undergone sternotomy surgery, with incidence rates ranging from 10% to 40%. Several mechanisms have been proposed to be responsible for the development of PSPS; for example, intercostal neuralgia from scar-entrapped neuroma, brachial plexus injury, ribs or costal fractures with incomplete healing, sternal wound infections and even hypersensitivity reaction to sternal wire. chronic post sternotomy pain (CPSP) can compromise quality of life, affecting their sleep patterns and impairing their working ability.
During the first week after coronary artery bypass grafting (CABG) surgery, vital capacity (VC) decreases by 30-60% and even up to 1 year this remains reduced by 12%. Reduced VC has a negative effect on exercise tolerance (Vo2max) and therefore it is important to optimize pulmonary function after CABG surgery. The decreased thoracic mobility after CABG still presents 12 months after surgery. Thoracic mobility and vital capacity were affected more when the left internal thoracic artery (LITA)-retractor was used and reduced thoracic mobility is related to diminished pulmonary function.
New therapeutic-rehabilitative proposals have been tried in cardiac patients. After cardiac surgery, it was found that the responses of the cardiovascular, and respiratory systems get better after neuromuscular manual therapy. The strong correlation between manual therapy and its effects, suggests that a central control mechanism could be activated by manual therapy.
Using Myofascial release (MFR) techniques may be beneficial for patients post-CABG and off-pump coronary artery bypass grafting (OPCAB) surgery. The advantages of MFR techniques are gentleness and non-invasiveness. During therapy one works with fascia structures, thus, not influencing bone structures directly, These techniques are comfortable and safe, they may be applied in acute conditions.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Post-sternotomy pain (CPSP), defined as discomfort at the thorax after cardiac surgery, persisting for at least 2 months, and without apparent cause (I.e., such as infection or the underlying disease that motivated the surgery).
- •Age between 55 to 65 years old.
- •All patients will be under full medical supervision.
- •Adherence to informed consent.
- •Cardiac sternotomy intervention
排除标准
- •Neuromuscular disorders.
- •Any Active hemorrhage.
- •The presence of an unstable cardiac, pulmonary or cerebral pathology.
- •Poor cognition and mentality.
- •Patients with active contagious skin conditions
- •Any Cardiopulmonary problems (eg. Uncontrolled hypertension, Heart Failure, Arrhythmia)
- •Patients with malignancy.
- •Any acute viral infection.
- •Patients with ascites or end-stage liver or kidney failure.
- •Patients will participate in other physiotherapy programs rather than the prescribed protocol.
- •Chest infection in last 3 months.
- •Patients with musculoskeletal problems like any bone fracture
- •Osteoporotic patients.
- •Any recent open wound in the chest are.
- •Hemodynamic instability.
研究组 & 干预措施
Myofascial release + Breathing exercises + Pharmacological treatment
It will include 30 patients, who will receive myofascial release for 5 days, with breathing exercises in addition to pharmacological treatment.
干预措施: Myofascial release (Other)
Myofascial release + Breathing exercises + Pharmacological treatment
It will include 30 patients, who will receive myofascial release for 5 days, with breathing exercises in addition to pharmacological treatment.
干预措施: Breathing exercises (Other)
Myofascial release + Breathing exercises + Pharmacological treatment
It will include 30 patients, who will receive myofascial release for 5 days, with breathing exercises in addition to pharmacological treatment.
干预措施: Pharmacological treatment (Drug)
Pharmacological treatment
It will include 30 patients, who will receive pharmacological treatment only.
干预措施: Pharmacological treatment (Drug)
结局指标
主要结局
Visual analog scale (VAS)
时间窗: 5 days
Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Upper chest expansion
时间窗: 5 days
It will be obtained by subtracting the inspiratory diameter from the expiratory diameter, according to the designated anatomical markers.
Lower chest expansion
时间窗: 5 days
It will be obtained by subtracting the inspiratory diameter from the expiratory diameter, according to the designated anatomical markers.
Pressure pain threshold
时间窗: 5 days
Pressure algometers are useful for quantifying the pressure pain thresholds of muscles. The pressure pain threshold of a patient is judged to be abnormal when the pressure pain threshold was lower than the normal value or if the pressure pain threshold of a certain site was lower than that of the opposite site by at least 2 kg/cm2, or if it was less than 3 kg/cm2.
次要结局
- Forced vital capacity (FVC)(5 days)
- Forced expiratory volume at one second (FEV1)(5 days)
- FEV1/FVC(5 days)
- Katz Index of Independence in Activities of Daily Living (ADL)(5 days)
- 6-min walk test (6 MWT)(5 days)
- Pittsburgh Sleep Quality Index (PSQI)(5 days)
- Arabic version of the 12-item short-form health survey (SF-12)(5 days)
- The Readiness for Return to Work (RRTW)(5 days)
研究者
Mayar Kamal Shehata Madian
Principal Investigator
Cairo University