跳至主要内容
临床试验/CTRI/2025/05/087738
CTRI/2025/05/087738尚未招募不适用

Efficacy of Mechanical Diagnosis and Treatment on Functionality and Capsular Thickness in Patients with Stage 2 Diabetic Adhesive Capsulitis.

Manav Rachna International Institute of Research and Studies1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年9月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
76
试验地点
1
主要终点
Standardized Quality of Life (QoL) Assessment through SF 36

研究概览

简要总结

Detailed demographic information, medical history, and baseline outcome measures will be collected from each participant to establish a comprehensive understanding of their condition. The participants in both with controlled (Group A1 and A2) and uncontrolled (Group B1 and B2) diabetic adhesive capsulitis groups will be assessed using the MDT assessment sheet. This will include history taking, observation of posture, range of motion testing, and repetitive movement testing and special tests. Groups A1 and B1, i.e., control groups 1 and 2, will be advised to follow exercise programs with conventional treatment (i.e. shoulder exercises, pamphlets will be given for the same) along with hot water fomentation as a home program. The participants in groups A2 and B2, i.e., experimental groups 1 and 2, will further be assessed according to the MDT approach.

Participants of all the groups would revisit the hospital to report changes the next day. The treatment would be modified if needed, or else he/she will be advised to continue until the symptoms diminish, i.e., pain and disability are decreased, and range of motion is increased. Pre-assessment and post-treatment outcome measures will be taken at 2 weeks to evaluate the effectiveness of the interventions. After completing the treatment, participants will be given a home exercise program for prophylaxis. Follow-up assessments will be conducted at 6 and 10 weeks, with outcome measures taken to evaluate the sustainability of treatment effects.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed case of type 2 diabetes mellitus with atleast 12 months duration having glycosylated haemoglobin (HbA1c) values between 5.5 to 12 percentage treated by diet, oral hypoglycaemic agents or insulin therapy.
  • Stage 2 adhesive capsulitis symptoms for atleast three months with greater than 25 percent restriction in PROM of the shoulder for atleast two directions (shoulder-abduction, -flexion, internal and external rotation) compared to the opposite shoulder.

排除标准

  • Patients with secondary adhesive capsulitis (e.g. traumatic adhesive capsulitis) Subject in inflammatory or chemical stage of adhesive capsulitis (If any 3 of following are present the participant would be excluded: VAS greater than 6, Night pain, redness, increased local temperature morning symptoms).
  • Inflammatory arthritis of the shoulder, polyarthritis, rheumatoid arthritis.
  • Bony deformity or pre-existing musculoskeletal disorders of the shoulder joint (rotator cuff injury, impingement disorder etc).
  • History of shoulder trauma (fractures or dislocations) or ligament injury for less than 6 months.
  • Injection to shoulder pain, invasive procedures or surgeries in the affected shoulder.
  • Cervical spondylosis or radiculopathy.
  • Uncontrolled comorbidities (moderate to severe anaemia, cardiovascular impairment, nephropathy etc) affecting the study outcomes.
  • Subjects with infections and coagulation disorders.

结局指标

主要结局

Standardized Quality of Life (QoL) Assessment through SF 36

时间窗: The outcome will be assessed at baseline, 2nd week, 6th week and 10th week

Upper Extremity Functional Index

时间窗: The outcome will be assessed at baseline, 2nd week, 6th week and 10th week

Range of Motion

时间窗: The outcome will be assessed at baseline, 2nd week, 6th week and 10th week

Visual Analog Scale

时间窗: The outcome will be assessed at baseline, 2nd week, 6th week and 10th week

Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

时间窗: The outcome will be assessed at baseline, 2nd week, 6th week and 10th week

Capsular thickness and coracohumeral ligament (CHL) thickness

时间窗: The outcome will be assessed at baseline, 2nd week, 6th week and 10th week

次要结局

未报告次要终点

研究者

申办方类型
Other [Private University]

研究点 (1)

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