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临床试验/NCT05948423
NCT05948423已完成不适用

Effect of Tissue Flossing Technique in Patients With Post Traumatic Elbow Stiffness.

Riphah International University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Goniometer

研究概览

简要总结

The purpose of this research is to determine the effect of tissue flossing technique on post-traumatic elbow stiffness, Pain and ROM. A randomized control trial was conducted at Pakistan ordinance factory (POF) Hospital Wah Cantt, Pakistan. The sample size was 36 calculated from G-power. 6 participants were excluded from the study and remaining 30 participants were divided into two groups, each having 15 participants. The study duration was six months. Sampling technique was applied was Non probability Convenience Sampling technique for recruitment and group randomization using random selection of participants. Both post-traumatic and post-operative male and female participants of aged 18-45 years with flexion <120° and loss of extension >30°. Tools used in this study are Liverpool elbow Score Questionnaire (LES), Goniometer and Visual Analogue Scale (VAS). Data was analyzed through SPSS version 23.

详细描述

Post traumatic or operative stiffness at elbow is quite common problem causes higher level of impairments in daily living activities i.e. use of mobile or computer, personal hygiene, dressing, eating, cooking that requires higher degree of elbow range of motion and adversely effects the quality of life (1).

The common reason of stiffness in elbow is trauma with rates ranging from 3% to 20% (1). Incidence of (PTES) is increased up to 56% after elbow trauma (2). Simultaneously radial head and elbow injuries increase incidence rate up to 90%, and 5-10% patients are effected by PTES even with an isolated injury to the radial head (3). Another study shows that exact incidence of elbow stiffness is not known but elbow injuries causes stiffness in approximately 12% of patients (1). Elbow stiffness causes can be categorized as traumatic, atraumatic and congenital (4).

Patients with well reduced and stabilized fracture are also suffer for soft tissue and capsule thickening leads to range of motion limitation. Stiff elbow has thickened capsule with high level of myofibroblast. This causes alteration in the auto-regulation of (TGF-β) transforming growth factor-beta. The influence of myofibroblasts is increased in initial period after trauma but deficient in chronic stiffness (>5 months) (4).

Treatment depends upon the cause of stiffness, stiffness time, severity of stiffness and involved movement of elbow (5). Treatment include CPM (continuous Passive motion), manipulation, stretching, active and passive exercises, mobilization, passive resistance exercises, passive mobilization with movements and PNF (proprioceptive neuromuscular facilitation technique) (6, 7). Physiotherapy is commonly used treatment both for prevention of post traumatic elbow stiffness and regain motion after surgery (7). Factors effecting PTES consist of patients and characteristics of fracture and treatment of fracture causes stiffness, pain, instability and functional limitations of elbow (4).

Clinically according to the severity, elbow stiffness is classified as very severe ( flexion/ extension arc <30), severe ( 30-60), moderate ( 61-90), minimal ( >90) (8). Diagnosis depends upon history, imaging and physical examination. Plain radiographs are useful to see joint congruity, osteophytes and myositis mass (6).

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
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age group between 18-45 years
  • Both male and female
  • Complete bone healing
  • Immobilization period 4-10 weeks
  • Flexion <120° and loss of extension >30°

排除标准

  • Those patient who have allergy to latex
  • Skin diseases
  • Venous Thrombotic disease
  • Cardio Pulmonary illness with Grade 3and 4
  • Myositis Ossificance

结局指标

主要结局

Goniometer

时间窗: 6 months

Universal goniometer measurements at Elbow ROM. The reliability ranged from 0.93 to 0.98 for the goniometric measurements (19).

Liverpool Elbow Scoring Questionnaire (LES)

时间窗: 6 months

Liverpool elbow Score is valid questionnaire specifically used to assess the functional scoring of elbow joint in elbow stiffness patients. LES contains nine-item (PAQ, P1-P9) patient-answered questionnaire along with six-item (CAS, C1-C6) clinical assessment score. All PAQ and CAS items were calculated with 0 to 10 numbers scale in which the lesser scores denoted greater symptom and functional severity. This scale has Good-to-excellent validity (0.45-0.89) (23).

Visual Analogue Scale

时间窗: 6 months

Pain intensity of elbow was measured by using Visual Analogue scale (VAS). VAS is mostly used assessment tool for intensity of pain in rehabilitation. It consists of unmarked 10cm horizontal line in which a patient mark on the line the point that they feel represents the perception of their pain ranges from '0cm' no pain to '100cm' very severe pain. The validity of VAS is 0.7 and reliability is (0.5) (48).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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