NCT04944446

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

September 23, 2020

Last Update Submit

June 21, 2021

Conditions

Keywords

ShoulderPathologyMyofascial releaseClinical trial

Outcome Measures

Primary Outcomes (6)

  • Functional capacity

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

    Baseline

  • Shoulder joint mobility

    Goniometer Records

    Baseline

  • Degree of pain

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

    Baseline

  • Functional capacity

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

    Change from Baseline at 4 weeks

  • Shoulder joint mobility

    Goniometer Records

    Change from Baseline at 4 weeks

  • Degree of pain

    Visual Analog Scale

    Change from Baseline at 4 weeks

Secondary Outcomes (3)

  • Pathology of access to the study

    Baseline

  • Age

    Baseline

  • Sex

    Baseline

Study Arms (2)

Group myofascial treatment

EXPERIMENTAL

The 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.

Other: Treatment

Group Kinesitherapy treatment

ACTIVE COMPARATOR

This 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.

Other: Treatment

Interventions

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

Group Kinesitherapy treatmentGroup myofascial treatment

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing and Physiotherapy. University of Cadiz

Cadiz, 11008, Spain

Location

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Humeral FracturesRotator Cuff Injuries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, BoneRuptureShoulder InjuriesTendon Injuries

Study Officials

  • Inés Carmona Barrientos, Dra.

    University of Cádiz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor) external evaluator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled longitudinal experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

June 29, 2021

Study Start

September 15, 2018

Primary Completion

September 5, 2020

Study Completion

January 15, 2021

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations