NCT03872063

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

March 10, 2019

Last Update Submit

January 23, 2020

Conditions

Keywords

VolleyballRange of motionMyofascialEccentricPain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from baseline perception of pain of the coracoid process after treatment and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

Myofascial

EXPERIMENTAL

Each session will last 17 minutes, taking place for 1 day a week, in a period of 4 weeks. The intervention will be carried out at the end of the training session. After the training, the technique of myofascial induction and eccentric exercises will be performed.

Other: Experimental

Eccentric

ACTIVE COMPARATOR

Each session will have a duration of 9 minutes, taking place during 1 day a week, in a period of 4 weeks. The intervention will be carried out at the end of the training session. After the training, the eccentric exercises will be performed.

Other: Control

Interventions

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

Also known as: Myofascial
Myofascial
ControlOTHER

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.

Also known as: Eccentric exercises
Eccentric

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volleyball players
  • Both gender
  • Age range of 18 to 35 years
  • Compete in a federated team in the Community of Madrid.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 12, 2019

Study Start

March 12, 2019

Primary Completion

April 15, 2019

Study Completion

June 20, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations