Radial Tunnel Syndrome in Resistant Lateral Epicondylitis
Ultrasonographic and Electrophysiological Evaluation of The Presence of Radial Tunnel Syndrome in Patients With Resistant Lateral Epicondylitis
1 other identifier
interventional
32
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2021
CompletedFirst Submitted
Initial submission to the registry
April 16, 2021
CompletedFirst Posted
Study publicly available on registry
April 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2021
CompletedFebruary 18, 2022
February 1, 2022
8 months
April 16, 2021
February 17, 2022
Conditions
Keywords
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
OTHERPatients 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
Interventions
ultrasound guided posterior interosseous nerve and lateral epicondyle 1 ml 2% lidocaine injection
Eligibility Criteria
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)
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: 12405872BACKGROUNDRitts GD, Wood MB, Linscheid RL. Radial tunnel syndrome. A ten-year surgical experience. Clin Orthop Relat Res. 1987 Jun;(219):201-5.
PMID: 3581572BACKGROUNDNewcomer 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: 16271686BACKGROUNDTran N, Chow K. Ultrasonography of the elbow. Semin Musculoskelet Radiol. 2007 Jun;11(2):105-16. doi: 10.1055/s-2007-1001876.
PMID: 18095243BACKGROUNDGurcay 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
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zeynep Ulku Akarirmak
Istanbul University - Cerrahpasa
- PRINCIPAL INVESTIGATOR
Aslinur Keles Ercisli
Istanbul University - Cerrahpasa
- STUDY CHAIR
Deniz Palamar Kadioglu
Istanbul University - Cerrahpasa
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