Comparative Effect of different Rehabilitation protocols among patients of Large to Massive Rotator Cuff Arthroscopic Repair involving Subscapularis tendon tear: A Randomized Contolled Trial
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
- Functional parameter in the terms of ROM ADL Pain Strength in the study population in early and delayed group and their correlation
研究概览
简要总结
The present parallel group RCT will be conducted in the Department of Orthopedics and Department of Physical Rehabilitation and Medicine at PGIMER Chandigarh with the following OBJECTIVE -
To compare the functional parameters among patients of arthroscopic repair of large to massive rotator cuff involving subscapularis tear in early mobilization and delayed mobilization group vs the patients without subscapularis involvement.
All enrolled patients will undergo arthroscopic repair for large to massive rotator cuff tear by an Orthopaedics surgeon of PGIMER Chandigarh. After arthroscopic confirmation**,** the patients with involvement of subscapularis, will be randomized into two groups, Early mobilization group (Intervention-1) and Delayed mobilization group (Intervention-2) i.e. after surgical procedure. The randomization will be done by simple randomization techniques by nursing officer working in the Orthopaedics ward. After arthroscopic repair, these patients will go for rehabilitation protocol (early and delayed rehabilitation protocol). The patients without subscapularis involvementwill be provided routine care in the hospital. They will also be kept under observation.
All the patients will be assessed for clinical outcome score measurement.
All above mentioned patients will go for arthroscopic repair and post operative rehabilitation after CTRI registration and Ethical approval from Institute Ethical Committee, PGIMER, Chandigarh.
The participants, intervention, comparator and outcome variable (PICO) are described as follows:
PICO Statement of the trial
P (Participant) = Patients of arthroscopic repair of large to massive rotator cuff involving the subscapularis tear.
I (Intervention) = early mobilization group; allocation ratio 1:1
C (Comparator) = Delayed mobilization group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient giving informed consent Age between 18 to 70 years Recent MRI findings and clinical tests suggestive of large to massive rotator cuff tear with involvement of Subscapularis muscle Rotator tears amenable to arthroscopic repair.
排除标准
- •Small to medium size tear size 1 to 3 cm Previous history of shoulder surgery infection and rotator cuff arthropathy Open rotator cuff repair Glenohumeral arthritis and inflammatory arthritis SLAP lesion Bankart lesion Shoulder instability Patients with grade 4 and 5 of Hamada classification based on AHI Irreparable rotator cuff tear Atrophy Occupation ratio retraction Patte classification fatty infiltration grade 3 and grade 4 of rotator cuff muscles based on Goutallier classification.
结局指标
主要结局
Functional parameter in the terms of ROM ADL Pain Strength in the study population in early and delayed group and their correlation
时间窗: At 2 weeks 4 weeks 6 weeks 3 months 4 months 5 months 6 months 9 months and 12 months.
次要结局
- Radiological parameters quality of life and physiological morbidity in the terms of retear sleep pattern anxiety and depression in the study population in early and delayed group and their correlation Proportion of subscapularis tear among cases of large to massive rotator cuff tear prevalence of functional limitation psychological morbidity social functioning deficits and night pain severity in the study population and their improvement after rehabilitation(At 2 weeks 4 weeks 6 weeks 3 months 4 months 5 months 6 months 9 months and 12 months.)
研究者
Ajit Kumar
PGIMER Chandigarh