Comparison of Conservative Treatment Methods for Sleep Disorders, Pain, and Shoulder Function in Patients With Supraspinatus Tendon Injury.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Constant-Murley Score
研究概览
简要总结
Rotator cuff injuries are a major cause of severe pain, often significantly impacting patients' sleep quality. For patients waiting for surgery or those not eligible for operative treatment, conservative treatment is recommended. In cases of minor injuries, physiotherapy is as effective as surgical intervention.
The aim of this study is: (1) to compare the speed, effectiveness, and durability of four implemented interventions in improving sleep quality, pain, and shoulder function, (2) to select the most optimal form of conservative treatment for patients with shoulder pain affecting sleep quality, and (3) to evaluate the expression of brain-derived neurotrophic factor (BDNF) and proBDNF (precursor) at the mRNA protein level before the planned intervention (T0), 1 month (T1), 3 months (T3), and 6 months (T6) after intervention.
The study results can assist physicians and physiotherapists in providing patients with therapy that not only relieves pain and improves function but also augments sleep quality, an aspect often overlooked in the literature yet greatly impacting patients' quality of life.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic partial incomplete thickness tear of the supraspinatus tendon, with a length below 1 cm and not exceeding 50% of the tendon thickness, confirmed by ultrasound examination.
- •Sleep disturbance symptoms for at least 1 month due to shoulder pain - PSQI score >
- •Shoulder pain disrupting the quality of sleep.
排除标准
- •Other accompanying pain symptoms.
- •History of shoulder surgery.
- •Coexistence of psychiatric or neurological disorders.
- •Presence of comorbidities that may disrupt sleep.
- •Presence of risk factors impairing tissue regeneration and increasing the likelihood of injury progression - osteoporosis, diabetes, hypercholesterolemia.
- •Alcohol dependence, nicotine addiction, passive smoking.
- •Taking antibiotics from the fluoroquinolone group, sleep-affecting medications (such as melatonin, trazodone, zolpidem), antidepressants, antipsychotics, anxiolytics.
- •Lack of patient consent, lack of cooperation, or impaired verbal-logical communication.
研究组 & 干预措施
Rehabilitation
Rehabilitation Treatment - a group of patients will be treated using a standardized rehabilitation protocol.
干预措施: Rehabilitation (Other)
Steroid
Rehabilitation treatment combined with a subacromial corticosteroid injection. Patients will receive 1ml of methylprednisolone acetate (40mg/ml) into the subacromial-subdeltoid bursa.
干预措施: 1ml of Depo-Medrol® injection (Drug)
Steroid
Rehabilitation treatment combined with a subacromial corticosteroid injection. Patients will receive 1ml of methylprednisolone acetate (40mg/ml) into the subacromial-subdeltoid bursa.
干预措施: Rehabilitation (Other)
PRP
Rehabilitation treatment combined with PRP injection. Patients will have an 11ml venous blood sample taken. After centrifugation, the obtained preparation will be administered to the patients intratendinously.
干预措施: Rehabilitation (Other)
PRP
Rehabilitation treatment combined with PRP injection. Patients will have an 11ml venous blood sample taken. After centrifugation, the obtained preparation will be administered to the patients intratendinously.
干预措施: Tropocells® PRP injection (Drug)
Nerve Block
Rehabilitation treatment combined with suprascapular nerve block. Patients will receive 4ml of 2% lidocaine around the suprascapular nerve.
干预措施: Rehabilitation (Other)
Nerve Block
Rehabilitation treatment combined with suprascapular nerve block. Patients will receive 4ml of 2% lidocaine around the suprascapular nerve.
干预措施: Nerve block with 4ml of 2% lidocaine (Drug)
结局指标
主要结局
Constant-Murley Score
时间窗: 6 months
The CMS is a widely used clinical assessment tool in orthopedics, specifically for evaluating shoulder function and outcomes following shoulder surgery or injury. The CMS comprises a set of objective and subjective measures to assess various aspects of shoulder function, including pain, range of motion, strength, and activities of daily living. These components are evaluated through a combination of patient-reported outcomes and physical examination by a healthcare professional.
Numeric pain Rating Scale
时间窗: 6 months
The NRS is a commonly used tool in clinical studies to assess pain intensity. It involves asking the patient to rate their pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain.
Range of motion measurements
时间窗: 6 months
The assessment of the range of motion of the upper limb (shoulder) is a standard procedure used to evaluate the function and mobility of the shoulder joint. This assessment involves examining the range of motion in various directions, including flexion, extension, abduction, adduction, external rotation, and internal rotation.
Strength measurements
时间窗: 6 months
The assessment of upper limb muscle strength using a dynamometer is a standard procedure used to measure the force exerted by the muscles of the shoulder and arm. This assessment involves using a handheld dynamometer to quantify the maximum force produced during specific muscle actions. Muscle strength measurement will be conducted during movements of flexion, extension, and external and internal rotation with the arm adducted and abducted.
BDNF and proBDNF Assessment
时间窗: 6 months
BDNF belongs to a family of proteins called neurotrophins, which act through tyrosine kinase receptors, influencing nerve cells. They exert a neuroprotective effect by stimulating neurogenesis and neuroplasticity processes. In the context of sleep disorders, BDNF may influence the structural stability of neurons in brain areas related to sleep regulation, such as the hippocampus or prefrontal cortex. Disruptions in the balance of this protein may contribute to various sleep disorders. Increased expression of this protein may also contribute to disturbances in normal neuronal processes.
Pittsburgh Sleep Quality Index
时间窗: 6 months
The PSQI is a self-assessment questionnaire that evaluates seven different aspects of sleep in adults. It assesses parameters of sleep quality such as difficulty with falling asleep, problems with maintaining sleep continuity, daytime functioning, and questions regarding the most common causes of sleep disturbances in the past four weeks. All of these contribute to a score rated from 0 to 21 points. Scores higher than 5 points indicate low sleep quality and differentiate patients into \'poor\' and \'good\' sleepers. A validated Polish version of the PSQI will be utilized in the study.
次要结局
- The Laitinen Pain Scale(6 months)
- The Simple Shoulder Test(6 months)
- The American Shoulder and Elbow Surgeons(6 months)
- Supraspinatous muscle echogenicity measurement(6 months)
- The assessment of the degree of fatty infiltration of the supraspinatus muscle(6 months)
- The Montreal Cognitive Assessment(6 months)
- The Trail Making Test(6 months)
- A 3D measurement of the Supraspinatus Injury(6 months)
- Ellman Classification of Partial-Thickness Rotator Cuff Tears(6 months)
- Athens Insomnia Scale(6 months)