Effect of Ozonated Gel Phonophoresis on Pain and Functional Disability in Patients With Chronic Supraspinatus Tendinitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of Pain intensity of shoulder joint
研究概览
简要总结
This study will be conducted to investigate the effect of ozonated gel phonophoresis on pain intensity, shoulder joint range of motion, and functional disability in patients with chronic supraspinatus tendinitis grades I and II.
详细描述
Tendinopathy is a condition in which pain arises on tendon near origin or insertion due to repetitive activities and reduced functional level, it occurs when the tendon does not properly heal.
Thirty percentages of tendinopathies in musculoskeletal conditions are shoulder pain related where supraspinatus tendinitis is the third most prevalent problem.
The primary function of the supraspinatus muscle is shoulder abduction, particularly movements that elevate the arm overhead. During these motions, the supraspinatus tendon repeatedly passes beneath the acromion process of the scapula, which can result in impingement and subsequent inflammation. If this condition progresses, an unexpected force or trauma may cause partial or complete rupture of the tendon.
Phonophoresis was first used to treat polyarthritis of hand by driving hydrocortisone ointment into inflamed areas in 1994. Since then it has been used in the treatment of various dermatological and musculoskeletal disorders.
The major medications used today with phonophoresis include the anti-inflammatories (cortisol, dexamethasone, salicylates) and local anaesthetics (lidocaine). Cameroy reports success using Carbocaine phonophoresis before closed reduction of Colles fractures.
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
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 30-60 years old from both genders.
- •The patients will be assigned to the study will be diagnosed with grade I or II supraspinatus tendinitis based on Neer's classification.
- •The patients suffered from supraspinatus tendinitis for more than 3 months and taking non-steroidal anti-inflammatory drugs suggested by orthopedist.
- •All patients have body mass index between 18.5 and 29.9 kg/m2.
排除标准
- •Grades III of supraspinatus tendinitis. (Bone spurs and tendon rapture)
- •Any past shoulder surgical interventions. (Rotator cuff repair, labrum tear and open reduction internal fixation)
- •Shoulder joint instability
- •Shoulder fracture.
- •Non-cooperative subjects.
- •Neuromuscular diseases (spinal muscular atrophy, whiplash injury)
- •Cardiovascular disease.
- •History of cancer.
- •Systemic diseases such as rheumatoid arthritis, Reiter's syndrome, or diabetes.
- •Severe medical and neurological or psychiatric disorders.
- •Pregnant and lactating women.
研究组 & 干预措施
ozonated gel phonophoresis + conventional treatment
Twenty patients will receive ozonated gel phonophoresis in addition to conventional treatment, three times per week for four weeks.
干预措施: ozonated gel phonophoresis (Other)
ozonated gel phonophoresis + conventional treatment
Twenty patients will receive ozonated gel phonophoresis in addition to conventional treatment, three times per week for four weeks.
干预措施: conventional treatment (Other)
conventional treatment
Twenty patients will receive conventional treatment consisting of hot pack application and stretching exercises targeting the upper trapezius and pectoralis minor muscles. Stretching will be performed for three repetitions, each held for 30 seconds with 30 seconds of rest between repetitions. This will be followed by strengthening exercises for the external shoulder rotators, lower trapezius, and serratus anterior muscles using color-coded elastic resistance bands, performed as three sets of ten repetitions for each muscle group. In addition, ultrasound therapy will be applied at a frequency of 1 MHz and an intensity of 0.8 W/cm² for 7 minutes. Treatment sessions will be conducted three times per week for four weeks.
干预措施: conventional treatment (Other)
结局指标
主要结局
Assessment of Pain intensity of shoulder joint
时间窗: 4 weeks
Pain intensity of the shoulder joint will be assessed using the Visual Analog Scale (VAS) in patients with chronic supraspinatus tendinitis. Patients will be asked to place a mark on a horizontal line to indicate the intensity of their pain, where the left end represents no pain and the right end represents the worst pain imaginable. VAS scores will be interpreted as follows: 0-30 indicates mild symptoms, 31-60 indicates moderate symptoms, and 61-100 indicates severe symptoms.
Assessment of Functional disability
时间窗: 4 weeks
The Quick Disabilities of the Arm, Shoulder, and Hand Scale (Quick DASH; Q-DASH) will be used to evaluate shoulder dysfunction. The QuickDASH consists of 11 items extracted from the original 30-item DASH questionnaire, including 8 function/disability items and 3 symptom items. Each item is scored on a 5-point scale ranging from 1 (no difficulty) to 5 (unable to do), with total scores ranging from 0 to 100, where higher scores indicate greater disability.
次要结局
- Assessment of Shoulder abduction range of motion(4 weeks)
- Assessment of Shoulder External Rotation range of motion(4 weeks)
研究者
Ahmed Mohsen Ali Abdallah
Principal Investigator
Cairo University