Role of Cervical Spine Mobilization on Lateral Epicondylitis

August 19, 2024 updated by: Ahmed ElMelhat, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt, 2334
        • Recruiting
        • Outpatient physical therapy, Faculty of physical therapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lateral epicondilitis with SNAG's
The intervention group, will receive mulligan's technique on C4-C7 cervical region and eccentric exercises to the affected forearm interventions done 2 times per week, 45 minutes each session for 4 weeks
Other: SNAGs - eccentric exercise
intervention done 2 times per week, 45 minutes each session for 4 weeks
Active Comparator: lateral epicondylitis

control group will receives only localized treatment as eccentric exercise, stretching of forearm extensors, cross-friction massage and ultrasound with frequency 3 MHz and intensity 2 W/cm2, 100% duty cycle on the affected forearm.

interventions done 2 times per week, 45 minutes each session for 4 weeks
Other: SNAGs - eccentric exercise
intervention done 2 times per week, 45 minutes each session for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leeds assessment of neuropathic symptoms and sign (LANSS) scale
Time Frame: 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.
Baseline
Pain-free hand grip test
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Numeric Rating Scale (NRS)
Time Frame: baseline
The Numeric Rating Scale (NRS) is a reliable and valid instrument for assessing pain intensity in chronic cases, as evidenced by its effective adaptation into an Arabic version: Arabic Numeric Pain Rating Scale (ANPRS). Reliability of the ANPRS (ICC 0.89) considered good to excellent. Arabic version of NRS considered reliable and valid tool to measure pain levels.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cervical spine mobilization

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lateral Epicondylitis

Clinical Trials on SNAGs - eccentric exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe