NCT06317545

Brief Summary

Painful condition of lateral epicondyle of the humerus characterized by the inflammation of the tendons during loading of the wrist extensor muscles is a common musculoskeletal presentation in men and women between 35 and 54 years of age. The above symptom is associated with a clinical diagnosis of lateral elbow tendinopathy (LET), also known as tennis elbow or lateral epicondylalgia the two effective treatment approaches for lateral epicondylitis are Nirschl exercises and Mulligan taping. This study aims to evaluate the effectiveness of Nirschl exercises with or without Mulligan taping in treating lateral epicondylitis. The study design for this project employs a randomized controlled trial and a sample of individuals with lateral epicondylitis randomly assigned in one of the two groups i.e., Nirschl exercises only and Nirschl exercises with Mulligan taping. Nirschl exercises involve the eccentric strengthening of the wrist extensor muscles and forearm. The participants in both groups will receive Nirschl exercises while the second group will also receive Mulligan taping, which involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons. Different outcome measures including pain intensity, functional disability, grip strength, range of motion will be evaluated using, PRTEE Scale, Visual Analogue Scale (VAS) and Calibrated Jammer hand held dynamometer. Statistical analysis, including independent t-tests or chi-square tests, will be conducted to compare the outcomes between the two groups. The significance level will be set at p \< 0.05. This study will contribute to the evidence base regarding the efficacy of Nirschl exercises and Mulligan taping in managing lateral epicondylitis and will help the clinicians and patients in deciding the best treatment approach for lateral epicondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

January 28, 2024

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    Pain will be measured using Visual Analogue Scale (VAS), min0 and max 10

    3 week consist of 6 sessions

  • Grip strength

    It will be measured using calibrated Jammer hand-held dynamometer.

    3 week consist of 6 sessions

Secondary Outcomes (1)

  • Disability

    3 week consist of 6 sessions

Study Arms (2)

Nirshl exercise with Mulligan Taping

EXPERIMENTAL

This group will be treated with Nirshl exercises with Mulligan taping

Other: Mulligan Taping

Nirshl exercise without Mulligan taping

NO INTERVENTION

This group will be treated with Nirshl exercises only.

Interventions

Mulligan taping involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons.

Nirshl exercise with Mulligan Taping

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain and tenderness over lateral epicondyle
  • at least two out of three tests for the lateral epicondylitis including Cozen's test, Mill's maneuver, or resisted middle finger extension positive

You may not qualify if:

  • Individuals with a history of recent trauma of upper limbs
  • Recent administration of platelet-rich plasma containing growth factors,
  • Patients which had taken physical therapy of any sort in the past 6 months
  • occupation-related pain were ruled out.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BARKI Advanced Physiotherapy Center

Multan, Punjab Province, 60000, Pakistan

Location

KAIMS Physiotherapy and Rehabilitation Center

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Sana ullah, MSPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2024

First Posted

March 19, 2024

Study Start

November 1, 2023

Primary Completion

March 28, 2024

Study Completion

March 28, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations