AzTrials
AzTrials

Humerus FractureNCT04944446

Myofascial Release in Shoulder Pathologies

A study testing Treatment in people with Humerus Fracture and Rotator Cuff Injuries, run by University of Cadiz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Shoulder pathology has a high prevalence in the field of musculoskeletal diagnoses, as well as being a common etiology in cases of disability. Passive and active-assisted kinesitherapy are used in the physiotherapy protocol. Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Humerus Fracture, Rotator Cuff Injuries
What is being tested?
Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSpain
Study dates
15 Sep 2018to 15 Jan 2021
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 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Be between 20 and 80 years old.
  • Patients who have been immobilized due to the following diagnoses: Suture of the rotator cuff or fracture of the proximal extremity of the humerus.
  • Have signed the informed consent of acceptance in the participation of the study

Who cannot join

  • Present neurological pathology.
  • Be subdued corticoid therapy.
  • Have anticoagulant treatment or have had it less than a month ago.
  • Insulin-dependent diabetic patients.
  • Patients with hemophilia.
  • Having diagnosed a psychological or psychiatric pathology.
  • Non-intervened displaced humerus fractures.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Faculty of Nursing and Physiotherapy. University of Cadiz

    Cadiz, 11008

Other trials in Spain

About this study

Official title: Effectiveness of Myofascial Release in Pathologies of the Shoulder

Shoulder pathology has a high prevalence in the field of musculoskeletal diagnoses, as well as being a common etiology in cases of disability. Passive and active-assisted kinesitherapy are used in the physiotherapy protocol. These techniques sometimes lead to feedback of fear and increased sensation of pain on the part of the patient that can slow or hinder the optimal recovery. A randomized clinical trial is intended to demonstrate that techniques for myofascial release of muscles important in the biomechanics of the shoulder, it is more effective than kinesitherapy in improving myofascial and also by eliminating the aforementioned unwanted effects and, therefore, improving the recovery of these processes.

Read the detailed description

The purpose of this study was to compare the efficacy of myofascial therapy and kinesitherapy in improving function in shoulder pathology with prolonged immobilization. Design Prospective, single-blind randomized controlled trial. Setting Inpatient department of a secondary university hospital. Participants Shoulder pain patients (N=44) were consecutively recruited and randomly assigned to an intervention or control group. Interventions Patients were randomly assigned to a Control Group, to which conventional kinesitherapy was applied, or to the intervention group to which a Myofascial therapy protocol was applied. Both groups completed a therapeutic exercise program based on specific mobilization and strengthening exercises. Main Outcome Measures The QuickDash questionnaire was the primary outcome, visual analog scale and the passive range of motion of the shoulder joint, grades were the secondary outcomes. The outcomes were evaluated at baseline (T0) and at 4 (T2),

Being tested
Treatment
Keywords
Shoulder, Pathology, Myofascial release, Clinical trial
Medical subject headings
Humeral Fractures, Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TreatmentOther

    Myofascial release of various muscle groups Treatment of mobilization of the shoulder joint

Study groups in NCT04944446
Study groupRoleWhat they receive
Group myofascial treatmentExperimentalThe trial group will also be referred by the rehabilitating doctor to the physiotherapy room, these patients will be treated by two physiotherapists with training in myofascial release therapy with which they will carry out a treatment protocol that will consist of myofascial release of the shoulder blade angle, subscapularis and global pectoral technique as well as superficial myofascial release of said musculature with a during 12-15 minutes, in addition to a 30-minute session of active kinesitherapy with exercises and mechanotherapy. Same as the control group. These mobilizations are carried out in the absence of pain, although the difference between joint tension or stretching and pain is explained to the patient.
Receives: Other: Treatment
Group Kinesitherapy treatmentActive comparatorThis group will be treated in a protocolized way with techniques such as passive kinesitherapy, active-assisted and active kinesitherapy to win mobility. They consist of mobilizing the affected arm in the movements of flexion (upward), separation (towards the outer side) and rotation, these lateral decubitus (bring the hand to the nape of the neck) and internal (bring the hand to the lower back) trying to win joint amplitude. These mobilizations are performed in the absence of pain, although the difference between joint tension or stretching and pain will be explained to the patient. The treatment will be carried out as usual with a duration of about 12-15 minutes of mobilization and about 30 minutes of active kinesitherapy with exercises and mechanotherapy, these consist of active shoulder mobility exercises. Emphasis will be placed on working with the pain threshold so as not to cause damage or negative nociceptive reactions.
Receives: Other: Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional capacity

    Dash Scale. Minimum: 0 Maximum: 100. Higher scores mean a worse outcome

    Measured: Baseline

  2. Shoulder joint mobility

    Goniometer Records

    Measured: Baseline

  3. Degree of pain

    Visual Analog Scale. Minimum: 0 Maximum: 10. Higher scores mean a worse outcome

    Measured: Baseline

  4. Functional capacity

    Dash Scale. Minimum: 0 Maximum: 100. Higher scores mean a worse outcome

    Measured: Change from Baseline at 4 weeks

  5. Shoulder joint mobility

    Goniometer Records

    Measured: Change from Baseline at 4 weeks

  6. Degree of pain

    Visual Analog Scale

    Measured: Change from Baseline at 4 weeks

Secondary outcomes (3)

  1. Pathology of access to the study

    Suture of the rotator cuff or fracture of the proximal limb of the humerus

    Measured: Baseline

  2. Age

    Years

    Measured: Baseline

  3. Sex

    Man or woman

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start15 Sep 2018
  3. Primary completion5 Sep 2020
  4. Study completion15 Jan 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled longitudinal experimental study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944446
Sponsor's protocol ID
InesCarmona
Status last verified
Jun 2021
First submitted
23 Sep 2020
Last updated
29 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.

    PubMed 25603749

  • Castro-Martin E, Ortiz-Comino L, Gallart-Aragon T, Esteban-Moreno B, Arroyo-Morales M, Galiano-Castillo N. Myofascial Induction Effects on Neck-Shoulder Pain in Breast Cancer Survivors: Randomized, Single-Blind, Placebo-Controlled Crossover Design. Arch Phys Med Rehabil. 2017 May;98(5):832-840. doi: 10.1016/j.apmr.2016.11.019. Epub 2016 Dec 18.

    PubMed 28003133

  • Rodriguez-Fuentes I, De Toro FJ, Rodriguez-Fuentes G, de Oliveira IM, Meijide-Failde R, Fuentes-Boquete IM. Myofascial Release Therapy in the Treatment of Occupational Mechanical Neck Pain: A Randomized Parallel Group Study. Am J Phys Med Rehabil. 2016 Jul;95(7):507-15. doi: 10.1097/PHM.0000000000000425.

    PubMed 26745225

  • Ajimsha MS, Chithra S, Thulasyammal RP. Effectiveness of myofascial release in the management of lateral epicondylitis in computer professionals. Arch Phys Med Rehabil. 2012 Apr;93(4):604-9. doi: 10.1016/j.apmr.2011.10.012. Epub 2012 Jan 10.

    PubMed 22236639

  • Castro-Sanchez AM, Mataran-Penarrocha GA, Granero-Molina J, Aguilera-Manrique G, Quesada-Rubio JM, Moreno-Lorenzo C. Benefits of massage-myofascial release therapy on pain, anxiety, quality of sleep, depression, and quality of life in patients with fibromyalgia. Evid Based Complement Alternat Med. 2011;2011:561753. doi: 10.1155/2011/561753. Epub 2010 Dec 28.

    PubMed 21234327

  • Sumariva-Mateos J, Leon-Valenzuela A, Vinolo-Gil MJ, Bautista Troncoso J, Del Pino Algarrada R, Carmona-Barrientos I. Efficacy of myofascial therapy and kinesitherapy in improving function in shoulder pathology with prolonged immobilization: A randomized, single-blind, controlled trial. Complement Ther Clin Pract. 2022 Aug;48:101580. doi: 10.1016/j.ctcp.2022.101580. Epub 2022 Apr 4.

    PubMed 35397306

Questions about this trial

What is this clinical trial studying?

A study testing Treatment in people with Humerus Fracture and Rotator Cuff Injuries, run by University of Cadiz 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 3 inclusion and 7 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 29 Jun 2021. 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?

Functional capacity (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944446, which also lists 6 linked publications.

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 29 Jun 2021.

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