NCT03830346

Brief Summary

Objective. To determine the effectiveness of instrument assisted soft tissue mobilization and horizontal adduction stretch in CrossFit practitioners' shoulders. Setting: Acero CrossFit center, city of Toledo (Spain) Design: Randomized, single-blind pilot study, with follow-up period. Participants: Twenty-one subjects of both sexes, being regular CrossFitters and in the age range of 18 to 40 years. Intervention: The experimental group (n = 11) received 30 seconds of stretching with isometric contraction of 5 seconds and instrument assisted soft tissue mobilization. The control group (n = 10) received only 40 seconds of instrument assisted soft tissue mobilization. Each session lasted 2 to 5 minutes, 2 days a week, over a period of 4 weeks, prior to each workout. Main Outcome measures: Shoulder internal rotation and horizontal adduction (digital inclinometer), and posterior shoulder stretch perception (Park scale) were evaluated.

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
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

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

First Submitted

Initial submission to the registry

January 31, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

January 31, 2019

Last Update Submit

February 1, 2019

Conditions

Keywords

Instrument Assisted Soft Tissue MobilizationManual TherapyMuscle Stretching ExercisesRange of motionShoulder JointCrossFit

Outcome Measures

Primary Outcomes (1)

  • Change from baseline internal rotation and horizontal adduction of the shoulder after treatment and at 1 month

    The patient was placed in the supine position at 90º shoulder abduction, 90º elbow flexion. By stabilizing the scapula at the acromion, the shoulder was taken at a maximum range of internal rotation. The range of motion was measured with a digital inclinometer, model Tacklife MDP01, the angle of the edge of the ulna coinciding with a line perpendicular to the stretcher. For horizontal adduction, the arm was placed in the same initial position in neutral rotation and while stabilizing the lateral edge of the scapula, the arm was adducted to its maximum range of motion. The angle between the line of the ventral edge of the humerus and a line perpendicular to the stretcher was measured with the inclinometer. The range of movement in internal rotation is 0-70º and the range in horizontal adduction is 0-30º (higher degrees, greater mobility in horizontal adduction of the shoulder).

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

Secondary Outcomes (1)

  • Change from baseline perception of stretch after treatment and at 1 month

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

Study Arms (2)

Experimental

EXPERIMENTAL

In the experimental group, instrument-assisted soft tissue mobilization techniques and post-isometric horizontal adduction stretches were performed. The technique lasted 20 seconds in a parallel direction and 20 seconds in a perpendicular direction on the posterior shoulder and scapula muscles. While the dominant hand was used to hold the instrument, the other hand was used to tighten the skin medially to ensure an even area of treatment.

Other: Instrument-assisted

Control

EXPERIMENTAL

Control group only underwent soft tissue mobilization. With the subject in the supine position, passively adducting the arm horizontally until the first motion barrier and performing active horizontal abduction for 5 seconds at 25% of force. The arm was then taken to the new motion barrier, repeating this process three times.

Other: Instrument-assisted

Interventions

instrument-assisted soft tissue mobilization techniques (applied with the subject in prone position. The technique lasted 20 seconds in a parallel direction and 20 seconds in a perpendicular direction on the posterior shoulder and scapula muscles. While the dominant hand was used to hold the instrument, the other hand was used to tighten the skin medially to ensure an even area of treatment) and post-isometric horizontal adduction stretches (carried out with the subject in the supine position, passively adducting the arm horizontally until the first motion barrier and performing active horizontal abduction for 5 seconds at 25% of force. The arm was then taken to the new motion barrier, repeating this process three times).

ControlExperimental

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects of both sexes
  • Being regular CrossFitters (workouts at least two days a week)
  • In the age range of 18 to 40 years

You may not qualify if:

  • Had suffered a shoulder injury in the 3 months prior to the study
  • Had undergone shoulder surgery in the previous six months
  • Had a non-attendance rate of over 15% of the intervention sessions (2 sessions)
  • Had not signed the informed consent document

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Real Fundación Victoria Eugenia

Madrid, 28029, Spain

Location

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
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 5, 2019

Study Start

February 1, 2019

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations