Back to resultsEffects of Scapular Strength Exercise for Patients With Lateral Epicondylalgia
Primary Purpose
Lateral Epicondylitis
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Scapular program
Conventional program
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring lateral epicondylalgia, tennis elbow, lateral epicondylitis, exercise, scapular muscle
Eligibility Criteria
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.
Sites / Locations
- Alcala UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1- Control group
Group 2 - Experimental group
Arm Description
They will performer the conventional exercise program por epicondylar muscles.
The experimental group will perform the conventional exercise program and also a scapular exercise program.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
grip strength
measured by dynamometer
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.
pressure threshold
measured by pressure algometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05373056
Brief Title
Effects of Scapular Strength Exercise for Patients With Lateral Epicondylalgia
Official Title
Effects of Scapular Strength Exercise for Patients With Lateral Epicondylalgia a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
June 25, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
lateral epicondylalgia, tennis elbow, lateral epicondylitis, exercise, scapular muscle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1- Control group
Arm Type
Active Comparator
Arm Description
They will performer the conventional exercise program por epicondylar muscles.
Arm Title
Group 2 - Experimental group
Arm Type
Experimental
Arm Description
The experimental group will perform the conventional exercise program and also a scapular exercise program.
Intervention Type
Behavioral
Intervention Name(s)
Scapular program
Intervention Description
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
Intervention Name(s)
Conventional program
Intervention Description
They will be performing a combination of concentric-eccentric type contractions adding an isometric contraction
Primary Outcome Measure Information:
Title
Visual Analog Scale for Pain
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Functionality
Description
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.
Time Frame
4 weeks
Title
grip strength
Description
measured by dynamometer
Time Frame
4 weeks
Title
The Quality of the lifestyle
Description
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.
Time Frame
4 weeks
Title
pressure threshold
Description
measured by pressure algometer
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro AY Ayuso Pablo, Msc
Phone
647396334
Ext
+34
Email
aayusopablo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kauzar KA Abdelkader Mohamed, Msc
Phone
620188570
Ext
+34
Email
kauzar6a@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro AY Ayuso Pablo, Msc
Organizational Affiliation
Alcala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alcala University
City
Madrid
State/Province
Alcala De Henares
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro AY Ayuso Pablo, Msc
Phone
647396334
Ext
+34º
Email
aayusopablo@gmail.com
First Name & Middle Initial & Last Name & Degree
KAUZAR AB Abdelkader Mohamed, Msc
Phone
620188570
Ext
+34
Email
kauzar6a@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Scapular Strength Exercise for Patients With Lateral Epicondylalgia
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