Radial Tunnel Syndrome in Resistant Lateral Epicondylitis

NCT ID: NCT04856228

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2021-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Lateral epicondylitis (LE), also known as "tennis elbow," is an overuse syndrome of the common extensor tendon (CET), predominantly affecting the extensor carpi radialis brevis. History and physical examination including manual provocation tests are key elements for the diagnosis.

Ultrasound imaging of the CET is an important complementary method to the clinical diagnosis of LE. It provides information about the severity of the disease with evidence of tendon thickening, focal/diffuse areas of decreased echogenicity in the tendon, epicondylar cortical irregularity or spur formation, and increased vascularity in case of local inflammation depicted by power- Doppler imaging.

Radial tunnel syndrome (RTS) is a dynamic/intermittent compression neuropathy of the radial nerve, where different structures can potentially compress the nerve. Local inflammatory and/or vascular changes (scarring, fibrosis), which are seen in LE may lead to compression of the radial nerve or its branches (especially the deep branch) at the radial tunnel. While RTS can often be the cause of refractory LE, some patients with LE actually have RTS concomitantly. The diagnosis of RTS is difficult/controversial due to inconclusive findings on electrophysiological tests and its close relationship with LE. Ultrasound is a superior imaging modality that can be used as an adjunct to electromyography for the evaluation of peripheral nerve problems. It can be used to diagnose compression neuropathies and to identify the entrapment site of the nerve. For the exact diagnosis of RTS complete relief should be achieved with a nerve block at the radial tunnel. Patients who have RTS coexisting with LE (18-43%) usually experience incomplete relief.

The purpose of the study is; to evaluate the RTS and LE with physical examination, special clinical tests, electrophysiological and ultrasonographic examinations and, to confirm the presence of RTS accompanying LE with the evaluation of clinical findings after the posterior interosseous nerve and lateral epicondyle diagnostic injections.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Radial Tunnel Syndrome Lateral Epicondylitis Radial Nerve Compression Epicondylitis of the Elbow

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

diagnostic single group

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

Group Type OTHER

diagnostic posterior interosseous nerve lidocaine injection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

diagnostic posterior interosseous nerve lidocaine injection

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

diagnostic lateral epicondyle lidocaine injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Fibromyalgia
2. History of surgery in the elbow
3. History of fracture that cause the deformity at radius/ulna
4. Pregnancy or breastfeeding
5. Inflammatuar arthropathy in upper extremities
6. Osteoarthritis in the upper extremities
7. Neurological disabilities that effect the upper extremity functions
8. Cervical radiculopathy that effect the level of C6-C7
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aslinur Keles Ercisli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zeynep Ulku Akarirmak

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Aslinur Keles Ercisli

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Deniz Palamar Kadioglu

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12405872 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3581572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16271686 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 18095243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27477582 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-83045809-604.01.02-7933

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.