Clinical trial NCT06271915: Role of Cervical Spine Mobilization on Lateral Epicondylitis
Official title: Effect of Cervical Spine Mobilization With Movement on Lateral Epicondylitis: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: Tennis Elbow, Elbos tendinitis, Cervical Spine, Manual Therapy.
Central sensitization
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

As such, the main objective of this study is to evaluate Mulligan's technique effectiveness in relieving mechanical and cold hyperalgesia in individuals with lateral epicondylitis, with a specific emphasis on the cervical spine region. Additionally, the research aims to investigate the impact of Mulligan's technique on central sensitization in the cervical spine and its influence on lateral epicondylitis.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Leeds assessment of neuropathic symptoms and sign (LANSS) scale
timeFrame: Baseline
measure: Pain-free hand grip test
timeFrame: Baseline
Secondary outcomes:
measure: The Numeric Rating Scale (NRS)
timeFrame: baseline
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Outpatient physical therapy, Faculty of physical therapy
Study officials:
References:
citation: Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.
citation: Cleland JA, Whitman JM, Fritz JM. Effectiveness of manual physical therapy to the cervical spine in the management of lateral epicondylalgia: a retrospective analysis. J Orthop Sports Phys Ther. 2004 Nov;34(11):713-22; discussion 722-4. doi: 10.2519/jospt.2004.34.11.713.