NCT04856228

Brief Summary

Lateral elbow pain can be difficult to diagnose because of the different pathologies or combinations of pathologies that can cause this clinic. Although lateral epicondylitis is the most common cause of lateral elbow pain, symptoms of radial tunnel syndrome may masquerade as lateral epicondylitis or they can be seen together with rate of 21-41%. The aim of the study is; to evaluate the presence of radial tunnel syndrome in the patients who have resistant lateral epicondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

April 16, 2021

Last Update Submit

February 17, 2022

Conditions

Keywords

radial nerveradial tunnel syndromelateral epicondylitisultrasonographyelectrophysiology

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Pain via Nurmerical Rating Scale at 30 Minutes after PIN/Lateral Epicondyle Injection

    Pain of the participants will be assessed by one of the most commonly used pain scale "numerical rating scale". It is numeric version of visual analog scale in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine". Participant is asked to indicate rates of their pain on the day of presentation during resting, during function and physical examination as a baseline and, 30 minutes after PIN injection for each, 30 minutes after lateral apicondyle injection for each.

    Baseline, 30 minutes after PIN injection, 30 minutes after lateral epicondyle injection

Secondary Outcomes (4)

  • Grip strength via dynamometer

    Baseline

  • The Patient-Rated Tennis Elbow Evaluation (PRTEE)

    Baseline

  • Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire

    Baseline

  • The 36-Item Short Form Health Survey Questionnaire (SF-36)

    Baseline

Study Arms (1)

diagnostic single group

OTHER

Patients diagnosed with lateral epicondylitis with physical examinations will be evaluated with electrophysiology After electrophysiological evaluations, patients' effected extremity evaluated with ultrasonography for lateral epicondylitis and radial tunnel syndrome and compared with uneffected side 30 minutes after posterior interosseous nerve block with 1 cc 2% lidocaine with USG guide, full examination will be repeated for evaluation of NRS score changing to exact diagnose of radial tunnel syndrome 30 minutes after lateral epicondyle 1 cc 2% lidocaine injection with USG guide, full examination will be repeated for evaluation of NRS score changing to final diagnose of lateral epicondylitis

Diagnostic Test: diagnostic posterior interosseous nerve lidocaine injection

Interventions

ultrasound guided posterior interosseous nerve and lateral epicondyle 1 ml 2% lidocaine injection

Also known as: diagnostic lateral epicondyle lidocaine injection
diagnostic single group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-65 years
  • Had persistent lateral elbow pain at least 6 months' duration with suspected lateral epicondylitis
  • Be able to understand enough Turkish to complete the outcome questionnaire
  • Patients whose informed consent was obtained for paticipation in the study

You may not qualify if:

  • Fibromyalgia
  • History of surgery in the elbow
  • History of fracture that cause the deformity at radius/ulna
  • Pregnancy or breastfeeding
  • Inflammatuar arthropathy in upper extremities
  • Osteoarthritis in the upper extremities
  • Neurological disabilities that effect the upper extremity functions
  • Cervical radiculopathy that effect the level of C6-C7

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (5)

  • Ekstrom RA, Holden K. Examination of and intervention for a patient with chronic lateral elbow pain with signs of nerve entrapment. Phys Ther. 2002 Nov;82(11):1077-86.

    PMID: 12405872BACKGROUND
  • Ritts GD, Wood MB, Linscheid RL. Radial tunnel syndrome. A ten-year surgical experience. Clin Orthop Relat Res. 1987 Jun;(219):201-5.

    PMID: 3581572BACKGROUND
  • Newcomer KL, Martinez-Silvestrini JA, Schaefer MP, Gay RE, Arendt KW. Sensitivity of the Patient-rated Forearm Evaluation Questionnaire in lateral epicondylitis. J Hand Ther. 2005 Oct-Dec;18(4):400-6. doi: 10.1197/j.jht.2005.07.001.

    PMID: 16271686BACKGROUND
  • Tran N, Chow K. Ultrasonography of the elbow. Semin Musculoskelet Radiol. 2007 Jun;11(2):105-16. doi: 10.1055/s-2007-1001876.

    PMID: 18095243BACKGROUND
  • Gurcay E, Karaahmet OZ, Kara M, Onat SS, Ata AM, Unlu E, Ozcakar L. Ultrasonographic Evaluation of the Radial Nerves in Patients with Unilateral Refractory Lateral Epicondylitis. Pain Med. 2017 Mar 1;18(3):396-402. doi: 10.1093/pm/pnw181.

    PMID: 27477582BACKGROUND

MeSH Terms

Conditions

Radial NeuropathyTennis Elbow

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesElbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Zeynep Ulku Akarirmak

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR
  • Aslinur Keles Ercisli

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Deniz Palamar Kadioglu

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 23, 2021

Study Start

January 10, 2021

Primary Completion

August 24, 2021

Study Completion

December 16, 2021

Last Updated

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations