NCT07723677

Brief Summary

Traction apophysitis of the medial epicondyle (MEC) is a common elbow injury in adolescent baseball players. The underlying pathology of the lesions associated with apophysitis seems to be due to repetitive traction stress via the medial ulnar collateral ligament (MUCL) to the skeletally immature MEC, as seen in young baseball players. Various types of morphological changes are observed at the MEC in baseball players, and fragmentation and hypertrophy have been commonly reported

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

July 19, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

August 2, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2026

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 19, 2026

Last Update Submit

July 19, 2026

Conditions

Keywords

Medial Epicondyle ApophysitisPowerBall

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale

    pain assessment tool, the scale ranged from 0-10 (at which 0 indicate no pain and 10 indicate sever pain)

    at day 0

  • Visual Analogue Scale

    pain assessment tool, the scale ranged from 0-10 (at which 0 indicate no pain and 10 indicate sever pain)

    at day 90

Secondary Outcomes (4)

  • Range of Motion

    at day 0

  • Range of Motion

    at day 90

  • Range of Motion

    at day 0

  • Range of Motion

    at day 90

Study Arms (2)

The Control Group Group (A)

EXPERIMENTAL
Other: the control group

The Study Group Group (B)

EXPERIMENTAL

The Study Group Group (B)

Other: BowerBall Group

Interventions

all adolescents will receive selected physical therapy program for 30 min. containing strengthening the muscles of upper limb, stretching for elbow flexors and forearms pronators plus 30 of BowerBalltraining

The Study Group Group (B)

All adolescents will receive 60 min. of the selected physical therapy program including strengthening the muscles of upper limb, stretching for elbow flexors and forearms pronators

Also known as: Group (A)
The Control Group Group (A)

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Their age will be ranging from 12 to 18 years.
  • Cases diagnosed with medial epicondyle apophysitis.
  • Cases participated in this study will from both sexes.
  • Cases receiving standard treatment protocol.
  • Cases with a disease duration of more than four months

You may not qualify if:

  • Cases with resent fractures in affected upper limb.
  • Cases diagnosis of any neurological disease or musculoskeletal disease affecting upper extremity functional ability.
  • Uncooperative cases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nehad A Abo-zaid

Asyut, Egypt

Location

Related Publications (6)

  • T. Tsuruta, H. Mine The primary treatment for the inferior fragmentation of humeral medial epicondyle in young baseball players J Jpn Elbow Soc, 20 (2013), pp. 92-95

    BACKGROUND
  • Takagishi K, Matsuura T, Masatomi T, Chosa E, Tajika T, Watanabe M, Iwama T, Otani T, Inagaki K, Ikegami H, Aoki M, Kato K, Okuwaki T, Sairyo K, Kameyama Y, Maeda A, Beppu M. Shoulder and elbow pain in elementary school baseball players: The results from a nation-wide survey in Japan. J Orthop Sci. 2017 Jul;22(4):682-686. doi: 10.1016/j.jos.2017.03.016. Epub 2017 May 3.

    PMID: 28478963BACKGROUND
  • Osbahr DC, Chalmers PN, Frank JS, Williams RJ 3rd, Widmann RF, Green DW. Acute, avulsion fractures of the medial epicondyle while throwing in youth baseball players: a variant of Little League elbow. J Shoulder Elbow Surg. 2010 Oct;19(7):951-7. doi: 10.1016/j.jse.2010.04.038. Epub 2010 Aug 5.

    PMID: 20688542BACKGROUND
  • Harada M, Takahara M, Sasaki J, Mura N, Ito T, Ogino T. Using sonography for the early detection of elbow injuries among young baseball players. AJR Am J Roentgenol. 2006 Dec;187(6):1436-41. doi: 10.2214/AJR.05.1086.

    PMID: 17114533BACKGROUND
  • Hodge C, Schroeder JD. Medial Epicondyle Apophysitis (Little League Elbow). 2023 Mar 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK570592/

    PMID: 34033354BACKGROUND
  • Otoshi K, Kikuchi S, Kato K, Kaneko Y, Mashiko R, Sato R, Igari T, Kaga T, Konno S. The influence of chronic medial epicondylar apophysitis on medial ulnar collateral ligament insufficiency-: a retrospective cohort study. JSES Int. 2022 Feb 1;6(3):539-544. doi: 10.1016/j.jseint.2021.12.014. eCollection 2022 May.

    PMID: 35572434BACKGROUND

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Nehad A Abo-zaid

    South Valley University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nehad A Abo-zaid,, Assistant Professor

CONTACT

Ola A A Kamal, Lecturer, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor) Duple blinded (Outcomes Assessor, patients) Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group 1 (control group) and Group 2 (PowerBall group),
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: G 1 (control) received traditional physical therapy program for 60 min. G 2 (study) received traditional physical therapy program for 30 min. and PowerBall for 30 min. all groups treated for 3 successive months.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assisant Professor of Physical Therapy for Pediatrics and Its Surgery

Study Record Dates

First Submitted

July 19, 2026

First Posted

July 23, 2026

Study Start (Estimated)

August 2, 2026

Primary Completion (Estimated)

October 8, 2026

Study Completion (Estimated)

November 20, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations