Lateral EpicondylitisNCT06271915
Role of Cervical Spine Mobilization on Lateral Epicondylitis
A study testing SNAGs - eccentric exercise in people with Lateral Epicondylitis, run by Cairo University at 1 site in Egypt.
Trial summary
The study's primary goal is to examine the effectiveness of Mulligan's technique in reducing hyperalgesia in lateral epicondylitis, focusing on cervical spine, while also investigating its influence on central sensitization in relation to lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- SNAGs - eccentric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2024to 15 Dec 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a positive Maudsley's test and Cozen's test,
- positive Spurling and axial distraction tests
- limited range of motion of the cervical spine
- a positive upper limb tension test (ULTT)
- middle-aged individuals (40-60 years old).
Who cannot join
- participants with any pathologies
- participants involved in other studies
- patients undergoing corticosteroids treatment
- physical therapy sessions, or surgical interventions for elbow or cervical spine issues within the past year
- individuals afflicted by inflammatory, infectious, or systematic diseases
- participants experiencing bilateral elbow pain or tumor diseases are excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient physical therapy, Faculty of physical therapy
Giza, 2334
Ahmed ElMelhat, 01112595022, ahmed.elmelhat@cu.edu.eg
About this study
Official title: Effect of Cervical Spine Mobilization With Movement on Lateral Epicondylitis: A Randomized Controlled Trial.
The study's primary goal is to examine the effectiveness of Mulligan's technique in reducing hyperalgesia in lateral epicondylitis, focusing on cervical spine, while also investigating its influence on central sensitization in relation to lateral epicondylitis.
Read the detailed description
Lateral epicondylitis (LE) also known as tennis elbow, results from an overuse injury due to eccentric overload on the common extensor tendon, particularly at the origin of the extensor carpi radialis brevis (ECRB). This condition is frequently triggered by repetitive strain during tasks involving repeated gripping and loaded wrist extension. Lateral epicondylitis affects 1% to 3% of population, especially in middle-aged people. In addition, patients with LE suffer from pain or burning on the common extensor origin of the forearm that may radiate into the upper arm or downward to the forearm. The pain can be exacerbated with resisted wrist extension, forearm supination and middle finger extension. The initial approach to manage lateral epicondylitis involves conservative therapy, including eccentric training, stretching and local manual therapy.
In individuals with lateral epicondylitis, the experience of mechanical hyperalgesia characterized by increased pain sensitivity during cold application is indicative of potential central sensitization. Central sensitization involves heightened reactivity of nociceptors within the central nervous system, resulting in increased responsiveness to both normal and sub-threshold afferent input. This heightened sensitivity also includes increased responsiveness to non-noxious stimuli and an elevated pain response triggered by stimuli originating outside the area of injury, indicating an expanded receptive field. Furthermore, cervical dysfunction is observable in individuals with LE even in the absence of neck pain indicating the involvement of central sanitization. The potential influence of cervical manual therapy on reducing mechanical hyperalgesia aligns with addressing central sensitization, contributing to a comprehensive approach in managing pain and sensitivity associated with lateral epicondylitis.
Its hypothesized that spinal manual therapy on the cervical spine is likely to yield positive short-term outcomes on pain-free grip and the pain threshold elicited by pressure over the lateral humeral epicondyle. As the mechanism of manual techniques proves effective on mechanical, neurophysiological, and peripheral receptors while inducing supraspinal pain inhibition related with sympathoexcitation3, hypoalgesia could occur following the application of these techniques.
Mulligan's mobilization and SNAGS approach involves applying force and direction to the facet joint, reaching the end range of motion. This technique aims to restore the original position of cervical spine facet joint which possibly impacts the hyperalgesia frequently associated with lateral epicondylitis. Moreover, mobilization with movement induces biomechanical changes in the vertebrae, affecting central processing. It restrains pain mechanisms, reduces neck dysfunction, and improves neck disability.
Notably, previous studies investigated, that they have indicated the need for further research to determine the effects of spinal manipulation on hypoalgesia. Furthermore, other study previously explored the effects of manual therapy on the thoracic spine concerning pain-free grip and sympathetic activity in patients with lateral epicondylitis producing favorable outcomes needing additional exploration when including the cervical spine.
As such, the main objective of this study is to evaluate Mulligan's technique effectiveness in relieving mechanical and cold hyperalgesia in individuals with lateral epicondylitis, with a specific emphasis on the cervical spine region. Additionally, the research aims to investigate the impact of Mulligan's technique on central sensitization in the cervical spine and its influence on lateral epicondylitis.
- Conditions
- Lateral Epicondylitis
- Being tested
- SNAGs - eccentric exercise
- Keywords
- Tennis Elbow, Elbos tendinitis, Cervical Spine, Manual Therapy., Central sensitization
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNAGs - eccentric exerciseOther
intervention done 2 times per week, 45 minutes each session for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| lateral epicondilitis with SNAG's | Experimental | The intervention group, will receive mulligan's technique on C4-C7 cervical region and eccentric exercises to the affected forearm interventions done 2 times per week, 45 minutes each session for 4 weeks Receives: Other: SNAGs - eccentric exercise |
| lateral epicondylitis | Active comparator | control group will receives only localized treatment as eccentric exercise, stretching of forearm extensors, cross-friction massage and ultrasound with frequency 3 MHz and intensity 2 W/cm2, 100% duty cycle on the affected forearm.
interventions done 2 times per week, 45 minutes each session for 4 weeks Receives: Other: SNAGs - eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leeds assessment of neuropathic symptoms and sign (LANSS) scale
is a questionnaire to screen neuropathic pain. It Contains five items concerning self-reported pain symptoms, and two items depending on simple clinical examination provided by healthcare professional that's targeting pin-prick threshold and allodynia. Scoring with LANSS: if the participant gains 12 or more out of 24, the pain will be considered of neuropathic origin. LANSS scale demonstrated a sensitivity (83%) and specificity of (87%), effectively identifying (85%) of neuropathic pain.
Measured: Baseline
Pain-free hand grip test
Pain-free grip test is a reliable and valid tool to use with lateral epicondylitis patients with using dynamometer to measure the grip force applied to the point of pain. Some studies recommended to perform the test with elbow relaxed extended, forearm pronated, and repeated 3 times with 1 minute interval, then comparing the average of 3 measurements between affected and non-affected.
Measured: Baseline
Secondary outcomes (1)
The Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) is a reliable and valid instrument for assessing pain intensity in chronic cases, as evidenced by its effective adaptation into an Arabic version: Arabic Numeric Pain Rating Scale (ANPRS). Reliability of the ANPRS (ICC 0.89) considered good to excellent. Arabic version of NRS considered reliable and valid tool to measure pain levels.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Feb 2024
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271915
- Sponsor's protocol ID
- cervical spine mobilization
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.
PubMed 26381484Cleland JA, Whitman JM, Fritz JM. Effectiveness of manual physical therapy to the cervical spine in the management of lateral epicondylalgia: a retrospective analysis. J Orthop Sports Phys Ther. 2004 Nov;34(11):713-22; discussion 722-4. doi: 10.2519/jospt.2004.34.11.713.
PubMed 15609491El Melhat AM, Elgayar SL, Elhalawaty AF, Koura GM, Takkoush M, Ismail AMA, Mohamed AA. Effects of adding sustained natural apophyseal glides on neuropathic pain-related symptoms and clinical outcomes in patients with lateral elbow tendinopathy: A randomized controlled trial. Physiother Theory Pract. 2026 Oct 20:1-15. doi: 10.1080/09593985.2026.2749509. Online ahead of print.
PubMed 42897970
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Spine Mobilization With Movement on Lateral Epicondylitis: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06271915
- Acronym / sponsor ID
- cervical spine mobilization
- Conditions
- Lateral Epicondylitis
- Keywords
- Tennis Elbow, Elbos tendinitis, Cervical Spine, Manual Therapy., Central sensitization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 22 Feb 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.
The study's primary goal is to examine the effectiveness of Mulligan's technique in reducing hyperalgesia in lateral epicondylitis, focusing on cervical spine, while also investigating its influence on central sensitization in relation to lateral epicondylitis.
Detailed description
Lateral epicondylitis (LE) also known as tennis elbow, results from an overuse injury due to eccentric overload on the common extensor tendon, particularly at the origin of the extensor carpi radialis brevis (ECRB). This condition is frequently triggered by repetitive strain during tasks involving repeated gripping and loaded wrist extension. Lateral epicondylitis affects 1% to 3% of population, especially in middle-aged people. In addition, patients with LE suffer from pain or burning on the common extensor origin of the forearm that may radiate into the upper arm or downward to the forearm. The pain can be exacerbated with resisted wrist extension, forearm supination and middle finger extension. The initial approach to manage lateral epicondylitis involves conservative therapy, including eccentric training, stretching and local manual therapy.
In individuals with lateral epicondylitis, the experience of mechanical hyperalgesia characterized by increased pain sensitivity during cold application is indicative of potential central sensitization. Central sensitization involves heightened reactivity of nociceptors within the central nervous system, resulting in increased responsiveness to both normal and sub-threshold afferent input. This heightened sensitivity also includes increased responsiveness to non-noxious stimuli and an elevated pain response triggered by stimuli originating outside the area of injury, indicating an expanded receptive field. Furthermore, cervical dysfunction is observable in individuals with LE even in the absence of neck pain indicating the involvement of central sanitization. The potential influence of cervical manual therapy on reducing mechanical hyperalgesia aligns with addressing central sensitization, contributing to a comprehensive approach in managing pain and sensitivity associated with lateral epicondylitis.
Its hypothesized that spinal manual therapy on the cervical spine is likely to yield positive short-term outcomes on pain-free grip and the pain threshold elicited by pressure over the lateral humeral epicondyle. As the mechanism of manual techniques proves effective on mechanical, neurophysiological, and peripheral receptors while inducing supraspinal pain inhibition related with sympathoexcitation3, hypoalgesia could occur following the application of these techniques.
Mulligan's mobilization and SNAGS approach involves applying force and direction to the facet joint, reaching the end range of motion. This technique aims to restore the original position of cervical spine facet joint which possibly impacts the hyperalgesia frequently associated with lateral epicondylitis. Moreover, mobilization with movement induces biomechanical changes in the vertebrae, affecting central processing. It restrains pain mechanisms, reduces neck dysfunction, and improves neck disability.
Notably, previous studies investigated, that they have indicated the need for further research to determine the effects of spinal manipulation on hypoalgesia. Furthermore, other study previously explored the effects of manual therapy on the thoracic spine concerning pain-free grip and sympathetic activity in patients with lateral epicondylitis producing favorable outcomes needing additional exploration when including the cervical spine.
As such, the main objective of this study is to evaluate Mulligan's technique effectiveness in relieving mechanical and cold hyperalgesia in individuals with lateral epicondylitis, with a specific emphasis on the cervical spine region. Additionally, the research aims to investigate the impact of Mulligan's technique on central sensitization in the cervical spine and its influence on lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral epicondilitis with SNAG's | Experimental | Other: SNAGs - eccentric exerciseThe intervention group, will receive mulligan's technique on C4-C7 cervical region and eccentric exercises to the affected forearm interventions done 2 times per week, 45 minutes each session for 4 weeks |
| lateral epicondylitis | Active comparator | Other: SNAGs - eccentric exercisecontrol group will receives only localized treatment as eccentric exercise, stretching of forearm extensors, cross-friction massage and ultrasound with frequency 3 MHz and intensity 2 W/cm2, 100% duty cycle on the affected forearm. interventions done 2 times per week, 45 minutes each session for 4 weeks |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- a positive Maudsley's test and Cozen's test,
- positive Spurling and axial distraction tests
- limited range of motion of the cervical spine
- a positive upper limb tension test (ULTT)
- middle-aged individuals (40-60 years old).
Key exclusion criteria (6 listed)
- participants with any pathologies
- participants involved in other studies
- patients undergoing corticosteroids treatment
- physical therapy sessions, or surgical interventions for elbow or cervical spine issues within the past year
- individuals afflicted by inflammatory, infectious, or systematic diseases
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 |
|---|---|---|
| SNAGs - eccentric exerciseintervention done 2 times per week, 45 minutes each session for 4 weeks | Other | lateral epicondilitis with SNAG's, lateral epicondylitis |
Primary outcome
Leeds assessment of neuropathic symptoms and sign (LANSS) scale
Time frame: Baseline
is a questionnaire to screen neuropathic pain. It Contains five items concerning self-reported pain symptoms, and two items depending on simple clinical examination provided by healthcare professional that's targeting pin-prick threshold and allodynia. Scoring with LANSS: if the participant gains 12 or more out of 24, the pain will be considered of neuropathic origin. LANSS scale demonstrated a sensitivity (83%) and specificity of (87%), effectively identifying (85%) of neuropathic pain.
Pain-free hand grip test
Time frame: Baseline
Pain-free grip test is a reliable and valid tool to use with lateral epicondylitis patients with using dynamometer to measure the grip force applied to the point of pain. Some studies recommended to perform the test with elbow relaxed extended, forearm pronated, and repeated 3 times with 1 minute interval, then comparing the average of 3 measurements between affected and non-affected.
1 secondary outcome
The Numeric Rating Scale (NRS)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Results publication: PubMed 26381484Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.
- Results publication: PubMed 15609491Cleland JA, Whitman JM, Fritz JM. Effectiveness of manual physical therapy to the cervical spine in the management of lateral epicondylalgia: a retrospective analysis. J Orthop Sports Phys Ther. 2004 Nov;34(11):713-22; discussion 722-4. doi: 10.2519/jospt.2004.34.11.713.
- Derived from this study: PubMed 42897970El Melhat AM, Elgayar SL, Elhalawaty AF, Koura GM, Takkoush M, Ismail AMA, Mohamed AA. Effects of adding sustained natural apophyseal glides on neuropathic pain-related symptoms and clinical outcomes in patients with lateral elbow tendinopathy: A randomized controlled trial. Physiother Theory Pract. 2026 Oct 20:1-15. doi: 10.1080/09593985.2026.2749509. Online ahead of print.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNAGs - eccentric exercise in people with Lateral Epicondylitis, run by Cairo University at 1 site in Egypt.
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 6 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 21 Aug 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 Egypt. 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 Ahmad El Melhat, Phd (01112595022, ahmed.elmelhat@cu.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leeds assessment of neuropathic symptoms and sign (LANSS) scale (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT06271915, which also lists 3 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 21 Aug 2024.