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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03872063
Other study ID # RADO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 12, 2019
Est. completion date June 20, 2019

Study information

Verified date January 2020
Source Investigación en Hemofilia y Fisioterapia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction. Myofascial therapy aims to improve fascial restrictions through the application of mechanical stimuli. The eccentric exercises involve the recruitment of fast fibers and help increase muscle volume.

Aim. Compare the effectiveness of myofascial induction intervention in the improvement of the range of motion of glenohumeral rotation and the pain perception, with respect to the use of eccentric exercises in volleyball players from 18 to 35 years of age.

Study design. Multicenter and single-blind randomized clinical study with follow-up period.

Methods. A random assignment of the 40 subjects recruited to the different study groups will be carried out: experimental (myofascial induction technique and eccentric exercises) and control (eccentric exercises). The intervention will last 4 weeks, with a weekly session of 17 and 7 minutes (in the experimental and control group, respectively). The dependent variables and measurement instruments will be: internal and external shoulder rotation (goniometry) and pain perception (visual analog scale). The Kolmogorov-Smirnov test will calculate the distribution of the sample, using parametric tests (t-student to calculate the difference of means between the evaluations in each group and ANOVA of repeated measures to calculate the intra- and intersubject effect) in case of normal.

Expected results. To improve the range of motion of glenohumeral joint global rotation and of the perception of pain of the subject.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 20, 2019
Est. primary completion date April 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Volleyball players

- Both gender

- Age range of 18 to 35 years

- Compete in a federated team in the Community of Madrid.

Exclusion Criteria:

- Have an injury to the osteoarticular complex of the shoulder at the time of the study or the previous 6 months

- Who are receiving a physiotherapy intervention at the time of the study or receiving analgesic drugs

- Not signed the informed consent document.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental
The intervention by myofascial induction will consist of the application of two techniques: global technique of myofascial induction of the pectoralis major muscle (once the tissue is placed in tension, the direction of fascia release in that region should be followed and as a result of the release, the caudal hand can move to the pelvis in any direction, to the right or to the left) and telescopic technique for the upper extremity of the subject's dominant arm (gently tractioning the upper limb of the subject, making a slight external rotation, so slow and progressive). The subjects will then perform the eccentric exercises, which will also be done by control group subjects
Control
The intervention by eccentric exercises will consist of two exercises using an elastic band. In the supine position, with the elastic band on the contralateral side attached to a fixed body perpendicular to the subject's hand performing a slow and constant movement of external rotation against resistance in an approximately 45 degree arc; holding for 5 seconds and relaxing slowly (perform 3 sets of 12 repetitions). The second exercise, with the elbow in 90 degrees of flexion and a shoulder abduction also of 90 degrees, with the elastic band in front of the subject, executing a movement against resistance performing an external rotation.

Locations

Country Name City State
Spain Universidad Europea de Madrid Madrid Comunity Of Madrid

Sponsors (1)

Lead Sponsor Collaborator
Investigación en Hemofilia y Fisioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline range of motion of shoulder after treatment and at month The measurement of the range of motion of shoulder will be made by means of a goniometric evaluation. The physiotherapist will be placed homolateral to the shoulder of the subject, being in the supine position with 90º shoulder abduction and 90º elbow flexion. While the goniometer will be positioned with the fulcrum in the olecranon, the fixed arm projected in the direction of the styloid process of the ulna and the movable arm follows the movement of the ulna. The range of normal mobility of the internal rotation of the shoulder is 0-100º and the external rotation of 0-80º (the total glenohumeral rotation range of 180º) if measured from the longitudinal axis of the arm. The unit of measurement is the degree, with a higher score indicating greater mobility of the shoulder joint. Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary Change from baseline perception of pain of the coracoid process after treatment and at month The assessment of the perception of pain of the coracoid process to palpation will be made with the Analog Visual Scale. The patient will be asked to indicate the pain that refers to the palpation in the region of the anterior aspect of the shoulder, in the area of the coracoid process. With this test the pain score of the subject will be measured, who will point in a straight line without dot marking between two extremes. The score range of this scale is 0-10, where 0 indicates no pain and 10 the maximum pain capable to endure. Screening visit, within the first seven days after treatment and after one month follow-up visit
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