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临床试验/NCT06469502
NCT06469502尚未招募不适用

Comparison of the Effectiveness of Stretching and Strengthening Exercises on Pain, Functional Status, Range of Motion and Psychosocial Factors in Patients With Frozen Shoulder

Istanbul University2 个研究点 分布在 2 个国家目标入组 56 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
56
试验地点
2
主要终点
NPRS

研究概览

简要总结

The aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.

详细描述

Frozen shoulder is a common disorder characterized by spontaneous shoulder pain, progressive inflammation and fibrosis of the joint capsule and loss of both active and passive glenohumeral range of motion.Exercise reduces pain, increases range of motion and function in patients with frozen shoulder. When investigators examine the literature, stretching and strengthening exercises are frequently encountered in the content of multimodal exercise programs applied clinically and at home in frozen shoulder. However, they have not been compared in isolation. Stretching is known to increase flexibility, while strengthening is often used to increase strength capacity and hypertrophy.Both exercise methods produce mechanical tension, known as a factor that stimulates anabolic metabolism and increases protein synthesis.Therefore, the aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.According to the power analysis result, 56 patients will be randomized into two groups (Group 1 =28, Group 2=28). The treatment will last for a total of 6 weeks and the follow-up period will be 6 weeks. Group 1 will be included in the program consisting of stretching exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of stretching exercises (3 times a week) under the supervision of a physiotherapist. Group 2 will be included in the program consisting of strengthening exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of strengthening exercises (3 times per week) under the supervision of a physiotherapist. The primary outcomes are the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire (Quick DASH) and the Numeric Pain Rating Scale (NPRS), while the secondary outcomes are the American Shoulder and Elbow Surgeons Standardized Shoulder Evaluation (ASES), Shoulder range of motion, Brief Pain Inventory-Short Form (BFI-SF) and Pain Catastrophizing Scale (PCS).

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 (Participant)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being between the ages of 40-65
  • Clinical and radiologic diagnosis of unilateral primary frozen shoulder
  • Being in frozen shoulder stages 2 and 3
  • Having an ROM of less than 50% in one or more directions of shoulder flexion, abduction, external rotation compared to the unaffected shoulder
  • Giving informed consent and volunteering
  • To have the ability to understand evaluation scales

排除标准

  • Neurological, cardiovascular, cerebrovascular disease
  • Those with severe mental illness or impaired consciousness
  • Upper extremity fractures and tumors
  • Rheumatic disease
  • Pathologies of cervical origin
  • Untreated shoulder trauma
  • Severe osteoporosis
  • Previous treatment for the current complaint (physiotherapy and rehabilitation, intra-articular injection, surgery)

结局指标

主要结局

NPRS

时间窗: baseline, after 6 weeks and 6 weeks follow up

Numeric Pain Rating Scale: The pain was measured using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable)

Quick DASH

时间窗: baseline, after 6 weeks and 6 weeks follow up

Quick Disabilities of the Arm, Shoulder, and Hand: The Quick DASH is a 11-item questionnaire used to assess upper limb functionality. The score ranges from 0 (no disability) to 100 (most severe disability).

次要结局

  • ASES(baseline, after 6 weeks and 6 weeks follow up)
  • Shoulder Range of Motion (ROM)(baseline, after 6 weeks and 6 weeks follow up)
  • BPI-SF(baseline, after 6 weeks and 6 weeks follow up)
  • PCS(baseline, after 6 weeks and 6 weeks follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Derya Celik

Professor

Istanbul University

研究点 (2)

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