Lateral Epicondylitis \(Tennis Elbow\)TT-ST-RN-LENCT06468514
Effectiveness of Neurodinamic Techniques on Radial Nerve for the Treatment of Lateral Epicondylalgia
A study testing neural tensioning technique on radial nerve and Sliding technique on radial nerve in people with Lateral Epicondylitis \(Tennis Elbow\), run by University of Alcala at 1 site in Spain.
Trial summary
Lateral elbow pain is a prevalent musculoskeletal disorder in the working population due to overuse of the upper limb. This pathology has serious consequences for health, work performance and overall health burden. In this injury, as in any musculoskeletal disorder, the peripheral nervous system is involved. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Lateral Epicondylitis \(Tennis Elbow\)
- What is being tested?
- neural tensioning technique on radial nerve and Sliding technique on radial nerve
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 24 Aug 2024to 15 Apr 2026
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient diagnosed with lateral epicondylalgia.
- Experiencing elbow pain of 2 to 6 months duration.
- Age between 30 and 60 years old.
- Radial humeral joint tenderness to palpation.
- Positive Cozen\'s test
Who cannot join
- - Bilateral symptoms.
- Rheumatologic disease involving the elbow and wrist
- Musculoskeletal disorder due to connective tissue pathology
- Cervical radiculopathy
- Nerve compression including the upper extremity
- Operation on the affected arm
Show all 11Show fewer
- Having received treatment for epicondylalgia in the last 6 months
- Radiating pain from the cervical spine
- Instability of the external ligamentous complex of the elbow(3).
- Not having received any physiotherapy session in the month prior to the start of the study.
- Neural clinical manifestations (electric shock-like pain, tingling, tingling, numbness and/or burning).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Campus Científico Tecnológico. Av. de León. 3A
Alcalá de Henares, Madrid, 28805
María Balsa Amarante, +34654050051, maria.balsa@edu.uah.es
María Balsa Amarante, MSc
About this study
Official title: Effectiveness of 'Tensioning Techniques' vs 'Sliding Techniques' on Radial Nerve for the Treatment of Lateral Epicondylalgia
Lateral elbow pain is a prevalent musculoskeletal disorder in the working population due to overuse of the upper limb. This pathology has serious consequences for health, work performance and overall health burden.
In this injury, as in any musculoskeletal disorder, the peripheral nervous system is involved. Because of its course and corresponding motor and sensory innervation in the area, the radial nerve should be taken into consideration as a structure involved in elbow pain.
The aim of the present study is to demonstrate which of the neurodynamic techniques is more effective in lateral epicondylalgia, neural tension techniques or neural mobilization techniques.
Read the detailed description
The aim of the present study is to demonstrate which is more effective among the neurodynamic techniques for lateral epicondylalgia, neural tension techniques or neural mobilization techniques.
A total of 60 subjects will be recruited and divided into 2 groups. 30 in Group 1 where they will receive a neural mobilization technique on the radial nerve and 30 in Group 2 where they will be subjected to a neural tension technique on the radial nerve.
The data to be collected will be grip strength, pain on pressure, pain and quality of life dash questionnaire, these data will be measured pre, post treatment and a re-evaluation at 4 weeks and 24 weeks after the intervention.
The duration of the treatment is 6 weeks, performing two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out.
- Conditions
- Lateral Epicondylitis \(Tennis Elbow\)
- Being tested
- neural tensioning technique on radial nerve, Sliding technique on radial nerve
- Keywords
- Epicondylalgia Neural mobilization Neural tension Physiotherapy Radial nerve
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neural tensioning technique on radial nerveOther
the neural group tensioning technique: The test should be performed in approximately 10° of shoulder abduction. The examiner extends the elbow 2 seconds just to the range where the patient notices tension but no pain and then the elbow is flexed. Three sets of 6-8 swings are performed with 1 minute rest in between.
Sliding technique on radial nerveOther
The mobilization maneuver begins by identifying the first resistance and the range of extension associated with pain. Maintaining elbow extension within the elastic region of resistance free of pain and/or paresthesia the examiner increases elbow extension and simultaneously allows the wrist to extend as necessary for the radial nerve branches in the forearm to glide proximally. The physical therapist then flexes the wrist while allowing the elbow to flex to cause the radial nerve excursion distally in the forearm.
| Study group | Role | What they receive |
|---|---|---|
| GRUPO 1 | Experimental | a Neural tension technique on the radial nerve will be performed. Receives: Other: neural tensioning technique on radial nerve |
| GRUPO 2 | Experimental | A neural gliding technique will be performed on the radial nerve. Receives: Other: Sliding technique on radial nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
his is a continuous quantitative variable. The measurement of grip strength is performed with the subject in a chair with backrest and armrests, his shoulder is in neutral position, and in adduction; the elbow in 90º flexion and the wrist in 30º extension. Participants are asked to perform maximal grip strength with the dynamometer in a self-selected grip position for 6 seconds. According to the American Society of Hand Therapists Guide, a Jamar® hydraulic dynamometer (Lafayette Instrument Company, USA) is used. The measurements were repeated 3 times, with an interval of 1 minute and the mean of the 3 measurements was used for statistical analysis.
Measured: the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.
Secondary outcomes (3)
Pain on pressure
This is a continuous quantitative variable. The pain threshold to pressure at the lateral epicondyle was measured with an algometer. The subject remains seated with the arm in 30° of abduction; the elbow in 90° of flexion; and with the forearm, wrist and hand resting on a table. The investigating physical therapist lightly palpates the common extensor tendon to identify the most tender area. Then, starting on the unaffected side, the head of the algometer (hard rubber tip, 1 cm2 surface area) is placed perpendicular to the common extensor tendon at the lateral epicondyle until the patient indicates the moment when the pressure sensation changes to pain. Three measurements are taken on both sides, with a 20-second rest interval between each measurement. The intraobserver reliability of these 3 measurements was excellent (ICC range, .91-.96). For the analysis, the mean value (in kg/cm2 ) of the 3 stresses was calculated. The maximum applied pressure was 6 kg/cm2 .
Measured: the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.
global pain
This is a discrete quantitative variable. Pain was measured using the Numerical Pain Rating Scale (NRS-P). The procedure is as follows, the patient is asked at the present moment what pain he/she feels from 0 to 10 if zero is zero pain and 10 is the maximum pain he/she has perceived. The NRS-P is a 10 cm long line calibrated from 0 to 10. 10. The NRS has been shown to have a test-retest reliability of 0.64 to 0.86, from good to excellent (7).
Measured: the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.
DASH QUESTIONARY
It is a discrete quantitative variable. The DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire is a self-administered outcome questionnaire that measures physical disability and symptoms of all upper extremity disorders. It includes 30 items related to 120 symptoms and activities of daily living. The total score is 100, and a higher score indicates a greater degree of disability.
Measured: the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start24 Aug 2024 (estimated)
- Primary completion24 Mar 2025 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lateral Epicondylitis \(Tennis Elbow\)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA BALSA AMARANTE, University of Alcala
- Investigators
- María Balsa-Amarante, MSc, Principal investigator, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468514
- Sponsor's protocol ID
- TECHNIQUES ON RADIAL NERVE
- Acronym
- TT-ST-RN-LE
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gamelas T, Fernandes A, Magalhaes I, Ferreira M, Machado S, Silva AG. Neural gliding versus neural tensioning: Effects on heat and cold thresholds, pain thresholds and hand grip strength in asymptomatic individuals. J Bodyw Mov Ther. 2019 Oct;23(4):799-804. doi: 10.1016/j.jbmt.2019.04.011. Epub 2019 Apr 24.
PubMed 31733764Ellis R, Carta G, Andrade RJ, Coppieters MW. Neurodynamics: is tension contentious? J Man Manip Ther. 2022 Feb;30(1):3-12. doi: 10.1080/10669817.2021.2001736. Epub 2021 Nov 16.
PubMed 34781843Yilmaz K, Yigiter Bayramlar K, Ayhan C, Tufekci O. Investigating the effects of neuromobilization in lateral epicondylitis. J Hand Ther. 2022 Jan-Mar;35(1):97-106. doi: 10.1016/j.jht.2020.11.003. Epub 2020 Nov 13.
PubMed 33563509Arumugam V, Selvam S, MacDermid JC. Radial nerve mobilization reduces lateral elbow pain and provides short-term relief in computer users. Open Orthop J. 2014 Oct 17;8:368-71. doi: 10.2174/1874325001408010368. eCollection 2014.
PubMed 25352930Taylor A, Wolff AL. The forgotten radial nerve: A conceptual framework for treatment of lateral elbow pain. J Hand Ther. 2021 Apr-Jun;34(2):323-329. doi: 10.1016/j.jht.2021.05.009. Epub 2021 Jun 27.
PubMed 34193382
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 'Tensioning Techniques' vs 'Sliding Techniques' on Radial Nerve for the Treatment of Lateral Epicondylalgia
- ClinicalTrials.gov ID
- NCT06468514
- Acronym / sponsor ID
- TT-ST-RN-LE / TECHNIQUES ON RADIAL NERVE
- Conditions
- Lateral Epicondylitis \(Tennis Elbow\)
- Keywords
- Epicondylalgia Neural mobilization Neural tension Physiotherapy Radial nerve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 24 Aug 2024 (estimated)
- Primary completion
- 24 Mar 2025 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 21 Jun 2024 (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 is a prevalent musculoskeletal disorder in the working population due to overuse of the upper limb. This pathology has serious consequences for health, work performance and overall health burden.
In this injury, as in any musculoskeletal disorder, the peripheral nervous system is involved. Because of its course and corresponding motor and sensory innervation in the area, the radial nerve should be taken into consideration as a structure involved in elbow pain.
The aim of the present study is to demonstrate which of the neurodynamic techniques is more effective in lateral epicondylalgia, neural tension techniques or neural mobilization techniques.
Detailed description
The aim of the present study is to demonstrate which is more effective among the neurodynamic techniques for lateral epicondylalgia, neural tension techniques or neural mobilization techniques.
A total of 60 subjects will be recruited and divided into 2 groups. 30 in Group 1 where they will receive a neural mobilization technique on the radial nerve and 30 in Group 2 where they will be subjected to a neural tension technique on the radial nerve.
The data to be collected will be grip strength, pain on pressure, pain and quality of life dash questionnaire, these data will be measured pre, post treatment and a re-evaluation at 4 weeks and 24 weeks after the intervention.
The duration of the treatment is 6 weeks, performing two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRUPO 1 | Experimental | Other: neural tensioning technique on radial nervea Neural tension technique on the radial nerve will be performed. |
| GRUPO 2 | Experimental | Other: Sliding technique on radial nerveA neural gliding technique will be performed on the radial nerve. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient diagnosed with lateral epicondylalgia.
- Experiencing elbow pain of 2 to 6 months duration.
- Age between 30 and 60 years old.
- Radial humeral joint tenderness to palpation.
- Positive Cozen\'s test
Key exclusion criteria (11 listed)
- - Bilateral symptoms.
- Rheumatologic disease involving the elbow and wrist
- Musculoskeletal disorder due to connective tissue pathology
- Cervical radiculopathy
- Nerve compression including the upper extremity
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 |
|---|---|---|
| neural tensioning technique on radial nervethe neural group tensioning technique: The test should be performed in approximately 10° of shoulder abduction. The examiner extends the elbow 2 seconds just to the range where the patient notices tension but no pain and then the elbow is flexed. Three sets of 6-8 swings are performed with 1 minute rest in between. | Other | GRUPO 1 |
| Sliding technique on radial nerveThe mobilization maneuver begins by identifying the first resistance and the range of extension associated with pain. Maintaining elbow extension within the elastic region of resistance free of pain and/or paresthesia the examiner increases elbow extension and simultaneously allows the wrist to extend as necessary for the radial nerve branches in the forearm to glide proximally. The physical therapist then flexes the wrist while allowing the elbow to flex to cause the radial nerve excursion distally in the forearm. | Other | GRUPO 2 |
Primary outcome
Grip strength
Time frame: the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.
his is a continuous quantitative variable. The measurement of grip strength is performed with the subject in a chair with backrest and armrests, his shoulder is in neutral position, and in adduction; the elbow in 90º flexion and the wrist in 30º extension. Participants are asked to perform maximal grip strength with the dynamometer in a self-selected grip position for 6 seconds. According to the American Society of Hand Therapists Guide, a Jamar® hydraulic dynamometer (Lafayette Instrument Company, USA) is used. The measurements were repeated 3 times, with an interval of 1 minute and the mean of the 3 measurements was used for statistical analysis.
3 secondary outcomes
Pain on pressure
Time frame: the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.
global pain
Time frame: the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.
DASH QUESTIONARY
Time frame: the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: PubMed 31733764Gamelas T, Fernandes A, Magalhaes I, Ferreira M, Machado S, Silva AG. Neural gliding versus neural tensioning: Effects on heat and cold thresholds, pain thresholds and hand grip strength in asymptomatic individuals. J Bodyw Mov Ther. 2019 Oct;23(4):799-804. doi: 10.1016/j.jbmt.2019.04.011. Epub 2019 Apr 24.
- Background: PubMed 34781843Ellis R, Carta G, Andrade RJ, Coppieters MW. Neurodynamics: is tension contentious? J Man Manip Ther. 2022 Feb;30(1):3-12. doi: 10.1080/10669817.2021.2001736. Epub 2021 Nov 16.
- Background: PubMed 33563509Yilmaz K, Yigiter Bayramlar K, Ayhan C, Tufekci O. Investigating the effects of neuromobilization in lateral epicondylitis. J Hand Ther. 2022 Jan-Mar;35(1):97-106. doi: 10.1016/j.jht.2020.11.003. Epub 2020 Nov 13.
- Background: PubMed 25352930Arumugam V, Selvam S, MacDermid JC. Radial nerve mobilization reduces lateral elbow pain and provides short-term relief in computer users. Open Orthop J. 2014 Oct 17;8:368-71. doi: 10.2174/1874325001408010368. eCollection 2014.
- Background: PubMed 34193382Taylor A, Wolff AL. The forgotten radial nerve: A conceptual framework for treatment of lateral elbow pain. J Hand Ther. 2021 Apr-Jun;34(2):323-329. doi: 10.1016/j.jht.2021.05.009. Epub 2021 Jun 27.
- Individual participant dataSharing planned: No
Related trials for Lateral Epicondylitis \(Tennis Elbow\)
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
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.
María Balsa-Amarante, MSc principal investigator
University of Alcalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neural tensioning technique on radial nerve and Sliding technique on radial nerve in people with Lateral Epicondylitis \(Tennis Elbow\), run by University of Alcala at 1 site in Spain.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Balsa-Amarante, MsC (34654050051, maria.balsa@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: the duration of the program will be 6 weeks, with two sessions per week with 72 hours of rest between sessions. A total of 12 sessions will be carried out. A re-evaluation will be done 4 weeks after the final evaluation and another one after 24 weeks.). 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 NCT06468514, which also lists 5 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 25 Jun 2024.