Effects of Scapular Strength Exercise for Patients With Lateral Epicondylalgia

NCT ID: NCT05373056

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2022-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

the aim of the study is to determine whether a scapular strength exercise program combined with a conventional exercise program in epicondylar region in patients with lateral epicondylalgia produces statistically significant improvements in pain in the short and medium term compared to a conventional exercise program.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

It is a single-blind clinical trial design, with third-party evaluation. There are two groups, the control group and the experimental group. In the control group, only the conventional exercise program for epicondylar muscles will be performed and the experimental group will also perform a scapular exercise program. Group assignment is randomized using the G\* POWER software program, following the inclusion and exclusion criteria. Variables related to pain, functionality, pressure pain threshold, prehensile strength and quality of life will be measured. The study will last 7 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lateral Epicondylitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are two groups, the control group and the experimental group. In the control group, only the conventional exercise program for epicondylar muscles will be performed and the experimental group will also perform a scapular exercise program. Group assignment is randomized using the G\* POWER software program.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1- Control group

They will performer the conventional exercise program por epicondylar muscles.

Group Type ACTIVE_COMPARATOR

Conventional program

Intervention Type BEHAVIORAL

They will be performing a combination of concentric-eccentric type contractions adding an isometric contraction

Group 2 - Experimental group

The experimental group will perform the conventional exercise program and also a scapular exercise program.

Group Type EXPERIMENTAL

Scapular program

Intervention Type BEHAVIORAL

the patient will be in prone. With the elbow extended, begin by raising the shoulder above the head, keeping the upper extremity in line with the fibers of the lower trapezius. The participant will then remain pronated with the elbow flexed at 90 degrees and the shoulder abducted and externally rotated. Starting from this position, you should exert the force towards external rotation and then return to internal rotation. For the last exercise, the subject will be placed in a standing position holding the elastic band with one hand while the other end will fix it to the ground, while stepping on it with the foot. You will start the movement with a shoulder elevation in the plane of the scapula above 120 degrees and then perform the eccentric returning to the starting position.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scapular program

the patient will be in prone. With the elbow extended, begin by raising the shoulder above the head, keeping the upper extremity in line with the fibers of the lower trapezius. The participant will then remain pronated with the elbow flexed at 90 degrees and the shoulder abducted and externally rotated. Starting from this position, you should exert the force towards external rotation and then return to internal rotation. For the last exercise, the subject will be placed in a standing position holding the elastic band with one hand while the other end will fix it to the ground, while stepping on it with the foot. You will start the movement with a shoulder elevation in the plane of the scapula above 120 degrees and then perform the eccentric returning to the starting position.

Intervention Type BEHAVIORAL

Conventional program

They will be performing a combination of concentric-eccentric type contractions adding an isometric contraction

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* tenderness over the epicondyle.
* Clinical diagnosis of LD for at least 3 months.
* Positive Mills and Maudsley test

Exclusion Criteria

* Patients with carpal tunnel syndrome, rheumatoid arthritis, cervical root syndrome, rotator cuff tendinopathy.
* Fractures or surgical history in the shoulder or elbow.
* History of elbow immobilization.
* Limitation in range of motion of the shoulder.
* Having undergone upper limb surgery in the last 6 months
* Unhealed wound in the region in the treatment area
* Impairment at a cognitive level that makes understanding with the therapist impossible.
* Neural entrapment of the radial nerve.
* Corticosteroid infiltration in the upper limb to be treated.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alcala

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alejandro Ayuso Pablo

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alejandro AY Ayuso Pablo, Msc

Role: PRINCIPAL_INVESTIGATOR

Alcala University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alcala University

Madrid, Alcala de Henares, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alejandro AY Ayuso Pablo, Msc

Role: CONTACT

647396334 ext. +34

Kauzar KA Abdelkader Mohamed, Msc

Role: CONTACT

620188570 ext. +34

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alejandro AY Ayuso Pablo, Msc

Role: primary

647396334 ext. +34º

KAUZAR AB Abdelkader Mohamed, Msc

Role: backup

620188570 ext. +34

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UAMaster123

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.