Effects of Scapular Strength Exercise for Patients With Lateral Epicondylalgia

Effects of Scapular Strength Exercise for Patients With Lateral Epicondylalgia a Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Behavioral: Conventional program; Behavioral: Scapular program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alejandro AY Ayuso Pablo, Msc; Phone Number: +34 647396334; Email: aayusopablo@gmail.com
• Study Contact Backup: Name: Kauzar KA Abdelkader Mohamed, Msc; Phone Number: +34 620188570; Email: kauzar6a@gmail.com

Study Locations

• Spain
  • Alcala De Henares
    • Madrid, Alcala De Henares, Spain, 28805
      • Recruiting
      • Alcala University
      • Contact: Alejandro AY Ayuso Pablo, Msc; Phone Number: +34º 647396334; Email: aayusopablo@gmail.com
      • Contact: KAUZAR AB Abdelkader Mohamed, Msc; Phone Number: +34 620188570; Email: kauzar6a@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1- Control group; They will performer the conventional exercise program por epicondylar muscles.	Behavioral: Conventional program; They will be performing a combination of concentric-eccentric type contractions adding an isometric contraction
Experimental: Group 2 - Experimental group; The experimental group will perform the conventional exercise program and also a scapular exercise program.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale for Pain	It will be measured with a 10 cm long horizontal line with descriptors at each end to help subjects identify their level of pain. The participants will mark with a cross the point of the line that most corresponds to the intensity of their symptoms. When interpreting the VAS, the respondent's cross position is usually assigned a score between 0 and 10. If documented on paper, pressures can simply be transferred to a scale of 100 values using a millimeter tape measure, although division into hundredths is considered sensitive enough.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality	measured with "the patient-rated tennis elbow evaluation Questionnaire".It is made up of 15 items, 5 focused on pain and the other 10 distributed between activities of daily living (4 items) and more specific activities (6 items). The result of each item is represented on a scale from 0 (totally painless activity) to 10 (maximum pain imaginable), so the total score can vary between 0 and 150.	4 weeks
grip strength	measured by dynamometer	4 weeks
The Quality of the lifestyle	measured with "The Short Form-36 Health Survey Questionnaire".It is evaluated on a scale from 0 to 100, with the highest score being the maximum possible health and well-being. Finally, a total score is obtained from the questionnaire considering a score of 0-19 = very low, 20-39 = relatively low, 40-59 = average, 60-79 = relatively high and 80-100 = very high.	4 weeks
pressure threshold	measured by pressure algometer	4 weeks

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Principal Investigator: Alejandro AY Ayuso Pablo, Msc, Alcala University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Anticipated): June 25, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: exercise; tennis elbow; lateral epicondylitis; lateral epicondylalgia; scapular muscle
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: UAMaster123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No