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Radial Tunnel Syndrome in Resistant Lateral Epicondylitis

Primary Purpose

Radial Tunnel Syndrome, Lateral Epicondylitis, Radial Nerve Compression

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
diagnostic posterior interosseous nerve lidocaine injection
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Radial Tunnel Syndrome focused on measuring radial nerve, radial tunnel syndrome, lateral epicondylitis, ultrasonography, electrophysiology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

diagnostic single group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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)
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
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

Full Information

First Posted
April 16, 2021
Last Updated
February 17, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04856228
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
December 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Tunnel Syndrome, Lateral Epicondylitis, Radial Nerve Compression, Epicondylitis of the Elbow
Keywords
radial nerve, radial tunnel syndrome, lateral epicondylitis, ultrasonography, electrophysiology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diagnostic single group
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
diagnostic posterior interosseous nerve lidocaine injection
Other Intervention Name(s)
diagnostic lateral epicondyle lidocaine injection
Intervention Description
ultrasound guided posterior interosseous nerve and lateral epicondyle 1 ml 2% lidocaine injection
Primary Outcome Measure Information:
Title
Change from Baseline Pain via Nurmerical Rating Scale at 30 Minutes after PIN/Lateral Epicondyle Injection
Description
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.
Time Frame
Baseline, 30 minutes after PIN injection, 30 minutes after lateral epicondyle injection
Secondary Outcome Measure Information:
Title
Grip strength via dynamometer
Description
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)
Time Frame
Baseline
Title
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
Description
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)
Time Frame
Baseline
Title
Disabilities of Arm, Shoulder, and Hand (DASH) Questionnaire
Description
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
Time Frame
Baseline
Title
The 36-Item Short Form Health Survey Questionnaire (SF-36)
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Ulku Akarirmak
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aslinur Keles Ercisli
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deniz Palamar Kadioglu
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
İstanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12405872
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. Erratum In: Phys Ther 2002 Dec;82(12):1268.
Results Reference
background
PubMed Identifier
3581572
Citation
Ritts GD, Wood MB, Linscheid RL. Radial tunnel syndrome. A ten-year surgical experience. Clin Orthop Relat Res. 1987 Jun;(219):201-5.
Results Reference
background
PubMed Identifier
16271686
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.
Results Reference
background
PubMed Identifier
18095243
Citation
Tran N, Chow K. Ultrasonography of the elbow. Semin Musculoskelet Radiol. 2007 Jun;11(2):105-16. doi: 10.1055/s-2007-1001876.
Results Reference
background
PubMed Identifier
27477582
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.
Results Reference
background

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Radial Tunnel Syndrome in Resistant Lateral Epicondylitis

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