NCT05373056

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

May 3, 2022

Last Update Submit

May 10, 2022

Conditions

Keywords

lateral epicondylalgiatennis elbowlateral epicondylitisexercisescapular muscle

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Functionality

    4 weeks

  • grip strength

    4 weeks

  • The Quality of the lifestyle

    4 weeks

  • pressure threshold

    4 weeks

Study Arms (2)

Group 1- Control group

ACTIVE COMPARATOR

They will performer the conventional exercise program por epicondylar muscles.

Behavioral: Conventional program

Group 2 - Experimental group

EXPERIMENTAL

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

Behavioral: Scapular program

Interventions

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.

Group 2 - Experimental group

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

Group 1- Control group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcala University

Madrid, Alcala de Henares, 28805, Spain

RECRUITING

MeSH Terms

Conditions

Tennis ElbowMotor Activity

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesBehavior

Study Officials

  • Alejandro AY Ayuso Pablo, Msc

    Alcala University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro AY Ayuso Pablo, Msc

CONTACT

Kauzar KA Abdelkader Mohamed, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 13, 2022

Study Start

February 28, 2022

Primary Completion

June 25, 2022

Study Completion

July 30, 2022

Last Updated

May 13, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations