NCT06471725

Brief Summary

The study recruited male sports hernias patients referred for physical therapy by an orthopedist or general practitioner from Damietta General Hospital. Participants had to be between 18 and 45 years old, have had sports hernia for two to ten weeks, and be willing and able to attend and stick to the Pilates exercise program for the trial's entire duration

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 18, 2024

Last Update Submit

June 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Typically, it consists of a 10 cm horizontal or vertical line with no pain at one end and the highest pain level at the other end.

    12 weeks

Secondary Outcomes (2)

  • Lower Extremity Functional Scale

    12 weeks

  • Harris Hip Score

    12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

will receive a combination of pilates exercises, Low-level laser therapy, and low-intensity ultrasound.

Other: combination of pilates exercises, Low-level laser therapy, and low-intensity ultrasound

Control

ACTIVE COMPARATOR

will be given Low-level laser therapy and low-intensity ultrasound

Other: combination of pilates exercises, Low-level laser therapy, and low-intensity ultrasound

Interventions

The core and hip muscles will be targeted through a customized workout program consisting of exercises such as Breathing, Planks, Side- Planks, Weighted lunges, Glute Bridge, Clamshell, Half-Kneeling Hip Flexor Stretch, Swan dive, Roll down, Ab curls, and Shoulder bridge, Low-intensity Ultrasound , and low level laser therapy

ControlExperimental

Eligibility Criteria

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

You may qualify if:

  • Participants had to be between 18 and 45 years old,
  • have had sports hernia for two to ten weeks
  • be willing and able to attend and stick to the Pilates exercise program for the trial's entire duration

You may not qualify if:

  • patients with preexisting injuries or conditions that could affect Pilates exercise participation
  • those with contraindications or exacerbating conditions from such exercises.
  • currently participating in other intensive exercise or rehabilitation programs
  • inability to give informed consent due to cognitive or communicative issues.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Delta university for science and technology

Al Mansurah, Dakahlia Governorate, 57357, Egypt

RECRUITING

Related Publications (1)

  • Elabd OM, Etoom M, Jahan AM, Elabd AM, Khedr AM, Elgohary HM. The Efficacy of Muscle Energy and Mulligan Mobilization Techniques for the Upper Extremities and Posture after Breast Cancer Surgery with Axillary Dissection: A Randomized Controlled Trial. J Clin Med. 2024 Feb 8;13(4):980. doi: 10.3390/jcm13040980.

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Central Study Contacts

Hany M Elgohary, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
This study is a controlled, double-blinded (patients and assessors)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2X2 model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 24, 2024

Study Start

June 19, 2024

Primary Completion

September 20, 2024

Study Completion

September 30, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations