NCT06271915

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

February 15, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

Tennis Elbow, Elbos tendinitis, Cervical Spine, Manual Therapy.Central sensitization

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline

Secondary Outcomes (1)

  • The Numeric Rating Scale (NRS)

    baseline

Study Arms (2)

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

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

Other: SNAGs - eccentric exercise

Interventions

intervention done 2 times per week, 45 minutes each session for 4 weeks

lateral epicondilitis with SNAG'slateral epicondylitis

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient physical therapy, Faculty of physical therapy

Giza, 2334, Egypt

RECRUITING

Related Publications (2)

  • 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.

  • Cleland 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.

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Central Study Contacts

Ahmad El Melhat, Phd

CONTACT

Maya Hafez, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisatnt Professor of Phyiscal Therapy

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 22, 2024

Study Start

February 15, 2024

Primary Completion

September 15, 2024

Study Completion

December 15, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

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