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临床试验/NCT06271915
NCT06271915招募中不适用

Effect of Cervical Spine Mobilization With Movement on Lateral Epicondylitis: A Randomized Controlled Trial.

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Pain-free hand grip test

研究概览

简要总结

The study's primary goal is to examine the effectiveness of Mulligan's technique in reducing hyperalgesia in lateral epicondylitis, focusing on cervical spine, while also investigating its influence on central sensitization in relation to lateral epicondylitis.

详细描述

Lateral epicondylitis (LE) also known as tennis elbow, results from an overuse injury due to eccentric overload on the common extensor tendon, particularly at the origin of the extensor carpi radialis brevis (ECRB). This condition is frequently triggered by repetitive strain during tasks involving repeated gripping and loaded wrist extension. Lateral epicondylitis affects 1% to 3% of population, especially in middle-aged people. In addition, patients with LE suffer from pain or burning on the common extensor origin of the forearm that may radiate into the upper arm or downward to the forearm. The pain can be exacerbated with resisted wrist extension, forearm supination and middle finger extension. The initial approach to manage lateral epicondylitis involves conservative therapy, including eccentric training, stretching and local manual therapy.

In individuals with lateral epicondylitis, the experience of mechanical hyperalgesia characterized by increased pain sensitivity during cold application is indicative of potential central sensitization. Central sensitization involves heightened reactivity of nociceptors within the central nervous system, resulting in increased responsiveness to both normal and sub-threshold afferent input. This heightened sensitivity also includes increased responsiveness to non-noxious stimuli and an elevated pain response triggered by stimuli originating outside the area of injury, indicating an expanded receptive field. Furthermore, cervical dysfunction is observable in individuals with LE even in the absence of neck pain indicating the involvement of central sanitization. The potential influence of cervical manual therapy on reducing mechanical hyperalgesia aligns with addressing central sensitization, contributing to a comprehensive approach in managing pain and sensitivity associated with lateral epicondylitis.

Its hypothesized that spinal manual therapy on the cervical spine is likely to yield positive short-term outcomes on pain-free grip and the pain threshold elicited by pressure over the lateral humeral epicondyle. As the mechanism of manual techniques proves effective on mechanical, neurophysiological, and peripheral receptors while inducing supraspinal pain inhibition related with sympathoexcitation3, hypoalgesia could occur following the application of these techniques.

Mulligan's mobilization and SNAGS approach involves applying force and direction to the facet joint, reaching the end range of motion. This technique aims to restore the original position of cervical spine facet joint which possibly impacts the hyperalgesia frequently associated with lateral epicondylitis. Moreover, mobilization with movement induces biomechanical changes in the vertebrae, affecting central processing. It restrains pain mechanisms, reduces neck dysfunction, and improves neck disability.

Notably, previous studies investigated, that they have indicated the need for further research to determine the effects of spinal manipulation on hypoalgesia. Furthermore, other study previously explored the effects of manual therapy on the thoracic spine concerning pain-free grip and sympathetic activity in patients with lateral epicondylitis producing favorable outcomes needing additional exploration when including the cervical spine.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • a positive Maudsley's test and Cozen's test,
  • positive Spurling and axial distraction tests
  • limited range of motion of the cervical spine
  • a positive upper limb tension test (ULTT)
  • middle-aged individuals (40-60 years old).

排除标准

  • participants with any pathologies
  • participants involved in other studies
  • patients undergoing corticosteroids treatment
  • physical therapy sessions, or surgical interventions for elbow or cervical spine issues within the past year
  • individuals afflicted by inflammatory, infectious, or systematic diseases
  • participants experiencing bilateral elbow pain or tumor diseases are excluded.

结局指标

主要结局

Pain-free hand grip test

时间窗: Baseline

Pain-free grip test is a reliable and valid tool to use with lateral epicondylitis patients with using dynamometer to measure the grip force applied to the point of pain. Some studies recommended to perform the test with elbow relaxed extended, forearm pronated, and repeated 3 times with 1 minute interval, then comparing the average of 3 measurements between affected and non-affected.

Leeds assessment of neuropathic symptoms and sign (LANSS) scale

时间窗: Baseline

is a questionnaire to screen neuropathic pain. It Contains five items concerning self-reported pain symptoms, and two items depending on simple clinical examination provided by healthcare professional that's targeting pin-prick threshold and allodynia. Scoring with LANSS: if the participant gains 12 or more out of 24, the pain will be considered of neuropathic origin. LANSS scale demonstrated a sensitivity (83%) and specificity of (87%), effectively identifying (85%) of neuropathic pain.

次要结局

  • The Numeric Rating Scale (NRS)(baseline)

研究者

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

Ahmed ElMelhat

Assisatnt Professor of Phyiscal Therapy

Cairo University

研究点 (2)

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