跳至主要内容
临床试验/NCT06449261
NCT06449261Unknown不适用

C5-C6 and Thoracic Spine Mobilization With Postural Correction Exercise Compared With Conventional Therapy in Patients With Adhesive Capsulitis - A Two-group, Parallel-arm, Single-blinded, Randomized Clinical Trial

Gulf Medical University3 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年2月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
66
试验地点
3
主要终点
Range of motion of shoulder

研究概览

简要总结

Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neural links are being studied on one side and postural alteration too was postulated to cause shoulder pathology. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. This study aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC. The outcome of the study must provide valid information to enhance the prognostic value of adhesive capsulitis.

详细描述

Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neurological control of the shoulder girdle muscles is mainly from cervical roots, particularly from C5/C6 roots, there was not sufficient research to associate this link with AC. Evidence confirms that there is an association between posture and shoulder mobility. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. We aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC.

Methods The protocol is written according to the SPIRIT statement to enhance transparency of content and completeness. Two-group, randomized controlled trial with blinded assessors. A total of 66 adults with AC will be randomly assigned to experimental group to receive C5-C6 and thoracic spine mobilization with postural correction sessions (n=33) and the others(n=33) in control group to receive conventional therapy within a period of 3 weeks. Primary outcomes are Shoulder Pain, range of motion (ROM) of the shoulder joint and Disability Index (SPADI) were to be measured at pre, postintervention following 3 weeks and 3 months..

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
27 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with AC & a Positive for Apley's scratch test.
  • Adhesive capsulitis (with symptoms for at least three months and less than 12 months[18]
  • Both Gender
  • Age 27-70
  • Sleep-disturbing night pain

排除标准

  • Patients who are unwilling to participate
  • patients with malignancy
  • AC Secondary to fracture and uncontrolled hypertension.
  • Unstable cardiac conditions
  • Patient with neurological conditions
  • Patient with reported concurrent cervical issues

结局指标

主要结局

Range of motion of shoulder

时间窗: 1 Year

The smartphone clinometer (Plaincode Software Solutions) is readily available at low cost for several smartphones, including the iPhone, which will be used by all examiners in this study

Cervical Range of motion

时间窗: 1 Year

Clinometer app on smartphones is a reliable and valid device for assessing cervical flexion, extension, lateral flexion, and rotation. The results from the study demonstrated moderate to excellent (ICC = .87-.96) concurrent validity in all 6 cervical movements when compared with the universal goniometric measurements

SPADY scale

时间窗: 1 Year

In the original version, the patient was instructed to place a mark on the VAS for each item that best represented their experience of their shoulder problem over the last week \[26\]. Each subscale is summed and transformed to a score out of 100. A mean is taken of the two subscales to give a total score out of 100, a higher score indicating greater impairment or disability.

次要结局

未报告次要终点

研究者

发起方
Gulf Medical University
申办方类型
Other
责任方
Sponsor

研究点 (3)

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