Clinical trial NCT04856228: Radial Tunnel Syndrome in Resistant Lateral Epicondylitis
Official title: Ultrasonographic and Electrophysiological Evaluation of The Presence of Radial Tunnel Syndrome in Patients With Resistant Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Tunnel Syndrome
Lateral Epicondylitis
Radial Nerve Compression
Epicondylitis of the Elbow
Keywords: radial nerve
radial tunnel syndrome
lateral epicondylitis
ultrasonography
electrophysiology
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Pain via Nurmerical Rating Scale at 30 Minutes after PIN/Lateral Epicondyle Injection
timeFrame: Baseline, 30 minutes after PIN injection, 30 minutes after lateral epicondyle injection
Secondary outcomes:
measure: Grip strength via dynamometer
timeFrame: Baseline
measure: The Patient-Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: Baseline
measure: Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire
timeFrame: Baseline
measure: The 36-Item Short Form Health Survey Questionnaire (SF-36)
timeFrame: Baseline
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Zeynep Ulku Akarirmak
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Aslinur Keles Ercisli
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Deniz Palamar Kadioglu
role: STUDY_CHAIR
References:
citation: 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.
citation: Ritts GD, Wood MB, Linscheid RL. Radial tunnel syndrome. A ten-year surgical experience. Clin Orthop Relat Res. 1987 Jun;(219):201-5.
citation: 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.
citation: Tran N, Chow K. Ultrasonography of the elbow. Semin Musculoskelet Radiol. 2007 Jun;11(2):105-16. doi: 10.1055/s-2007-1001876.
citation: 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.