Radial Tunnel SyndromeNCT04856228
Radial Tunnel Syndrome in Resistant Lateral Epicondylitis
A study testing diagnostic posterior interosseous nerve lidocaine injection in people with Radial Tunnel Syndrome and Lateral Epicondylitis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radial Tunnel Syndrome, Lateral Epicondylitis, Radial Nerve Compression
- What is being tested?
- diagnostic posterior interosseous nerve lidocaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2021to 16 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34098
About this study
Official title: Ultrasonographic and Electrophysiological Evaluation of The Presence of Radial Tunnel Syndrome in Patients With Resistant Lateral Epicondylitis
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.
Read the 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.
- Conditions
- Radial Tunnel Syndrome, Lateral Epicondylitis, Radial Nerve Compression, Epicondylitis of the Elbow
- Being tested
- diagnostic posterior interosseous nerve lidocaine injection
- Keywords
- radial nerve, radial tunnel syndrome, lateral epicondylitis, ultrasonography, electrophysiology
- Medical subject headings
- Radial Neuropathy, Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic posterior interosseous nerve lidocaine injectionDiagnostic test
Also called diagnostic lateral epicondyle lidocaine injection
ultrasound guided posterior interosseous nerve and lateral epicondyle 1 ml 2% lidocaine injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: diagnostic posterior interosseous nerve lidocaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 30 minutes after PIN injection, 30 minutes after lateral epicondyle injection
Secondary outcomes (4)
Grip strength via dynamometer
Handgrip strength was measured by using a Jamar Hand Dynamometer with patients seated, their elbow by their side and flexed to right angles, and a neutral wrist position. Three measurements were performed for both side, and the mean score was recorded (effected site and dominancy were noted)
Measured: Baseline
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
PRTEE is a validated pain severity and functional disability scale that assesses pain (5 questions graded 0 to 10) and functional disability (10 questions graded 0 to 10). Functional scores are then halved and added to pain scores. The minimum score is 0 (no pain or disability) and the maximum is 100 (severe pain and disability)
Measured: Baseline
Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire
The DASH is a validated questionnaire designed to measure upper limb disability and symptoms. Functional domains include physical, social, and psychological. It uses a single-scale, 30-item questionnaire of upper extremity function and symptoms. The minimum sum score is 30 points; the maximumscore is 150 points
Measured: Baseline
The 36-Item Short Form Health Survey Questionnaire (SF-36)
SF-36 is a popular instrument for evaluating Health-Related Quality of Life and commonly used, general health assessment that is reliable and valid for overall outcome. It measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start10 Jan 2021
- Primary completion24 Aug 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Radial Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslinur Keles Ercisli, Istanbul University - Cerrahpasa
- Investigators
- Zeynep Ulku Akarirmak, Study director, Istanbul University - CerrahpasaAslinur Keles Ercisli, Principal investigator, Istanbul University - CerrahpasaDeniz Palamar Kadioglu, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856228
- Sponsor's protocol ID
- E-83045809-604.01.02-7933
- Status last verified
- Feb 2022
- First submitted
- 16 Apr 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12405872Ritts GD, Wood MB, Linscheid RL. Radial tunnel syndrome. A ten-year surgical experience. Clin Orthop Relat Res. 1987 Jun;(219):201-5.
PubMed 3581572Newcomer 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.
PubMed 16271686Tran N, Chow K. Ultrasonography of the elbow. Semin Musculoskelet Radiol. 2007 Jun;11(2):105-16. doi: 10.1055/s-2007-1001876.
PubMed 18095243Gurcay 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.
PubMed 27477582Keles A, Palamar D, Gunduz A, Akarirmak U. Ultrasonographic and Electrophysiologic Assessment of Radial Tunnel Syndrome in Patients With Treatment-Resistant Lateral Epicondylitis: Insights into Diagnostic Utility and Clinical Implications. Am J Phys Med Rehabil. 2026 Apr 1;105(4):330-337. doi: 10.1097/PHM.0000000000002877. Epub 2025 Oct 9.
PubMed 41082715
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic and Electrophysiological Evaluation of The Presence of Radial Tunnel Syndrome in Patients With Resistant Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT04856228
- Acronym / sponsor ID
- E-83045809-604.01.02-7933
- Conditions
- Radial Tunnel Syndrome, Lateral Epicondylitis, Radial Nerve Compression, Epicondylitis of the Elbow
- Keywords
- radial nerve, radial tunnel syndrome, lateral epicondylitis, ultrasonography, electrophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic single group | Other | Diagnostic Test: diagnostic posterior interosseous nerve lidocaine injectionPatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic posterior interosseous nerve lidocaine injectionAlso: diagnostic lateral epicondyle lidocaine injectionultrasound guided posterior interosseous nerve and lateral epicondyle 1 ml 2% lidocaine injection | Diagnostic test | diagnostic single group |
Primary outcome
Change from Baseline Pain via Nurmerical Rating Scale at 30 Minutes after PIN/Lateral Epicondyle Injection
Time frame: Baseline, 30 minutes after PIN injection, 30 minutes after 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.
4 secondary outcomes
Grip strength via dynamometer
Time frame: Baseline
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: Baseline
Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire
Time frame: Baseline
The 36-Item Short Form Health Survey Questionnaire (SF-36)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Background: PubMed 12405872Ekstrom 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.
- Background: PubMed 3581572Ritts GD, Wood MB, Linscheid RL. Radial tunnel syndrome. A ten-year surgical experience. Clin Orthop Relat Res. 1987 Jun;(219):201-5.
- Background: PubMed 16271686Newcomer 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.
- Background: PubMed 18095243Tran N, Chow K. Ultrasonography of the elbow. Semin Musculoskelet Radiol. 2007 Jun;11(2):105-16. doi: 10.1055/s-2007-1001876.
- Background: PubMed 27477582Gurcay 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.
- Derived from this study: PubMed 41082715Keles A, Palamar D, Gunduz A, Akarirmak U. Ultrasonographic and Electrophysiologic Assessment of Radial Tunnel Syndrome in Patients With Treatment-Resistant Lateral Epicondylitis: Insights into Diagnostic Utility and Clinical Implications. Am J Phys Med Rehabil. 2026 Apr 1;105(4):330-337. doi: 10.1097/PHM.0000000000002877. Epub 2025 Oct 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Ulku Akarirmak study director
Istanbul University - Cerrahpasa
Aslinur Keles Ercisli principal investigator
Istanbul University - Cerrahpasa
Deniz Palamar Kadioglu study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic posterior interosseous nerve lidocaine injection in people with Radial Tunnel Syndrome and Lateral Epicondylitis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pain via Nurmerical Rating Scale at 30 Minutes after PIN/Lateral Epicondyle Injection (time frame: Baseline, 30 minutes after PIN injection, 30 minutes after lateral epicondyle injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04856228, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.