Myofascial PainNCT03872063
Myofascial Induction and Eccentric Exercises in Volleyball Players
A study testing Experimental in people with Myofascial Pain, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2019to 20 Jun 2019
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volleyball players
- Both gender
- Age range of 18 to 35 years
- Compete in a federated team in the Community of Madrid.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Physiotherapy Program Through Myofascial Induction and Eccentric Exercises in the Improvement of Mobility and the Perception of Nonspecific Pain in the Shoulder Joint in Volleyball Players. A Randomized Pilot Study
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.
Read more
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.
- Conditions
- Myofascial Pain
- Being tested
- Experimental, Control
- Keywords
- Volleyball, Range of motion, Myofascial, Eccentric, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Myofascial
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
ControlOther
Also called Eccentric exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start12 Mar 2019
- Primary completion15 Apr 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872063
- Sponsor's protocol ID
- RADO
- Status last verified
- Jan 2020
- First submitted
- 10 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physiotherapy Program Through Myofascial Induction and Eccentric Exercises in the Improvement of Mobility and the Perception of Nonspecific Pain in the Shoulder Joint in Volleyball Players. A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03872063
- Acronym / sponsor ID
- RADO
- Conditions
- Myofascial Pain
- Keywords
- Volleyball, Range of motion, Myofascial, Eccentric, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 12 Mar 2019 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial | Experimental | Other: ExperimentalEach 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. |
| Eccentric | Active comparator | Other: ControlEach 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volleyball players
- Both gender
- Age range of 18 to 35 years
- Compete in a federated team in the Community of Madrid.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| ExperimentalAlso: MyofascialThe 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 | Other | Myofascial |
| ControlAlso: Eccentric exercisesThe 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. | Other | Eccentric |
Primary outcome
Change from baseline range of motion of shoulder after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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.
1 secondary outcome
Change from baseline perception of pain of the coracoid process after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Myofascial Pain, run by Investigación en Hemofilia y Fisioterapia 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline range of motion of shoulder after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 27 Jan 2020.