Lateral EpicondylitisNCT05373056
Effects of Scapular Strength Exercise for Patients With Lateral Epicondylalgia
A study testing Scapular program and Conventional program in people with Lateral Epicondylitis, run by University of Alcala at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Scapular program and Conventional program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 28 Feb 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- tenderness over the epicondyle.
- Clinical diagnosis of LD for at least 3 months.
- Positive Mills and Maudsley test
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Alcala University
Madrid, Alcala de Henares, 28805
Alejandro AY Ayuso Pablo, Msc, 647396334 ext. +34º, aayusopablo@gmail.com
KAUZAR AB Abdelkader Mohamed, Msc, 620188570 ext. +34, kauzar6a@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- Scapular program, Conventional program
- Keywords
- lateral epicondylalgia, tennis elbow, lateral epicondylitis, exercise, scapular muscle
- Medical subject headings
- Tennis Elbow, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular programBehavioural
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.
Conventional programBehavioural
They will be performing a combination of concentric-eccentric type contractions adding an isometric contraction
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Control group | Active comparator | They will performer the conventional exercise program por epicondylar muscles. Receives: Behavioral: Conventional program |
| Group 2 - Experimental group | Experimental | The experimental group will perform the conventional exercise program and also a scapular exercise program. Receives: Behavioral: Scapular program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (4)
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.
Measured: 4 weeks
grip strength
measured by dynamometer
Measured: 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.
Measured: 4 weeks
pressure threshold
measured by pressure algometer
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start28 Feb 2022
- Primary completion25 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Ayuso Pablo, University of Alcala
- Investigators
- Alejandro AY Ayuso Pablo, Msc, Principal investigator, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373056
- Sponsor's protocol ID
- UAMaster123
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scapular Strength Exercise for Patients With Lateral Epicondylalgia a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05373056
- Acronym / sponsor ID
- UAMaster123
- Conditions
- Lateral Epicondylitis
- Keywords
- lateral epicondylalgia, tennis elbow, lateral epicondylitis, exercise, scapular muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 25 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1- Control group | Active comparator | Behavioral: Conventional programThey will performer the conventional exercise program por epicondylar muscles. |
| Group 2 - Experimental group | Experimental | Behavioral: Scapular programThe experimental group will perform the conventional exercise program and also a scapular exercise program. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- tenderness over the epicondyle.
- Clinical diagnosis of LD for at least 3 months.
- Positive Mills and Maudsley test
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scapular programthe 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. | Behavioural | Group 2 - Experimental group |
| Conventional programThey will be performing a combination of concentric-eccentric type contractions adding an isometric contraction | Behavioural | Group 1- Control group |
Primary outcome
Visual Analog Scale for Pain
Time frame: 4 weeks
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 secondary outcomes
Functionality
Time frame: 4 weeks
grip strength
Time frame: 4 weeks
The Quality of the lifestyle
Time frame: 4 weeks
pressure threshold
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro AY Ayuso Pablo, Msc principal investigator
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scapular program and Conventional program in people with Lateral Epicondylitis, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro AY Ayuso Pablo, Msc (647396334 ext. +34, aayusopablo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.