NCT06468514

Brief Summary

Lateral elbow pain is a prevalent musculoskeletal disorder in the working population due to overuse of the upper limb. This pathology has serious consequences for health, work performance and overall health burden. In this injury, as in any musculoskeletal disorder, the peripheral nervous system is involved. Because of its course and corresponding motor and sensory innervation in the area, the radial nerve should be taken into consideration as a structure involved in elbow pain. The aim of the present study is to demonstrate which of the neurodynamic techniques is more effective in lateral epicondylalgia, neural tension techniques or neural mobilization techniques.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 24, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 15, 2024

Last Update Submit

June 21, 2024

Conditions

Keywords

Epicondylalgia Neural mobilization Neural tension Physiotherapy Radial nerve

Outcome Measures

Primary Outcomes (1)

  • Grip strength

    his is a continuous quantitative variable. The measurement of grip strength is performed with the subject in a chair with backrest and armrests, his shoulder is in neutral position, and in adduction; the elbow in 90º flexion and the wrist in 30º extension. Participants are asked to perform maximal grip strength with the dynamometer in a self-selected grip position for 6 seconds. According to the American Society of Hand Therapists Guide, a Jamar® hydraulic dynamometer (Lafayette Instrument Company, USA) is used. The measurements were repeated 3 times, with an interval of 1 minute and the mean of the 3 measurements was used for statistical analysis.

    the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.

Secondary Outcomes (3)

  • Pain on pressure

    the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.

  • global pain

    the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.

  • DASH QUESTIONARY

    the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.

Study Arms (2)

GRUPO 1

EXPERIMENTAL

a Neural tension technique on the radial nerve will be performed.

Other: neural tensioning technique on radial nerve

GRUPO 2

EXPERIMENTAL

A neural gliding technique will be performed on the radial nerve.

Other: Sliding technique on radial nerve

Interventions

the neural group tensioning technique: The test should be performed in approximately 10° of shoulder abduction. The examiner extends the elbow 2 seconds just to the range where the patient notices tension but no pain and then the elbow is flexed. Three sets of 6-8 swings are performed with 1 minute rest in between.

GRUPO 1

The mobilization maneuver begins by identifying the first resistance and the range of extension associated with pain. Maintaining elbow extension within the elastic region of resistance free of pain and/or paresthesia the examiner increases elbow extension and simultaneously allows the wrist to extend as necessary for the radial nerve branches in the forearm to glide proximally. The physical therapist then flexes the wrist while allowing the elbow to flex to cause the radial nerve excursion distally in the forearm.

GRUPO 2

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient diagnosed with lateral epicondylalgia.
  • Experiencing elbow pain of 2 to 6 months duration.
  • Age between 30 and 60 years old.
  • Radial humeral joint tenderness to palpation.
  • Positive Cozen\'s test

You may not qualify if:

  • \- Bilateral symptoms.
  • Rheumatologic disease involving the elbow and wrist
  • Musculoskeletal disorder due to connective tissue pathology
  • Cervical radiculopathy
  • Nerve compression including the upper extremity
  • Operation on the affected arm
  • Having received treatment for epicondylalgia in the last 6 months
  • Radiating pain from the cervical spine
  • Instability of the external ligamentous complex of the elbow(3).
  • Not having received any physiotherapy session in the month prior to the start of the study.
  • Neural clinical manifestations (electric shock-like pain, tingling, tingling, numbness and/or burning).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Científico Tecnológico. Av. de León. 3A

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (5)

  • Gamelas T, Fernandes A, Magalhaes I, Ferreira M, Machado S, Silva AG. Neural gliding versus neural tensioning: Effects on heat and cold thresholds, pain thresholds and hand grip strength in asymptomatic individuals. J Bodyw Mov Ther. 2019 Oct;23(4):799-804. doi: 10.1016/j.jbmt.2019.04.011. Epub 2019 Apr 24.

    PMID: 31733764BACKGROUND
  • Ellis R, Carta G, Andrade RJ, Coppieters MW. Neurodynamics: is tension contentious? J Man Manip Ther. 2022 Feb;30(1):3-12. doi: 10.1080/10669817.2021.2001736. Epub 2021 Nov 16.

    PMID: 34781843BACKGROUND
  • Yilmaz K, Yigiter Bayramlar K, Ayhan C, Tufekci O. Investigating the effects of neuromobilization in lateral epicondylitis. J Hand Ther. 2022 Jan-Mar;35(1):97-106. doi: 10.1016/j.jht.2020.11.003. Epub 2020 Nov 13.

    PMID: 33563509BACKGROUND
  • Arumugam V, Selvam S, MacDermid JC. Radial nerve mobilization reduces lateral elbow pain and provides short-term relief in computer users. Open Orthop J. 2014 Oct 17;8:368-71. doi: 10.2174/1874325001408010368. eCollection 2014.

    PMID: 25352930BACKGROUND
  • Taylor A, Wolff AL. The forgotten radial nerve: A conceptual framework for treatment of lateral elbow pain. J Hand Ther. 2021 Apr-Jun;34(2):323-329. doi: 10.1016/j.jht.2021.05.009. Epub 2021 Jun 27.

    PMID: 34193382BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • María Balsa-Amarante, MSc

    University of Alcalá

    PRINCIPAL INVESTIGATOR

Central Study Contacts

María Balsa-Amarante, MsC

CONTACT

Tomás Gallego Izquierdo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT

Study Record Dates

First Submitted

June 15, 2024

First Posted

June 21, 2024

Study Start

August 24, 2024

Primary Completion

March 24, 2025

Study Completion

April 15, 2026

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations