- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04944446
Myofascial Release in Shoulder Pathologies
Effectiveness of Myofascial Release in Pathologies of the Shoulder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cádiz, Spain, 11008
- Faculty of Nursing and Physiotherapy. University of Cadiz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group myofascial treatment
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. |
Myofascial release of various muscle groups Treatment of mobilization of the shoulder joint
|
Active Comparator: Group Kinesitherapy treatment
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. |
Myofascial release of various muscle groups Treatment of mobilization of the shoulder joint
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional capacity
Time Frame: Baseline
|
Dash Scale.
Minimum: 0 Maximum: 100.
Higher scores mean a worse outcome
|
Baseline
|
Shoulder joint mobility
Time Frame: Baseline
|
Goniometer Records
|
Baseline
|
Degree of pain
Time Frame: Baseline
|
Visual Analog Scale.
Minimum: 0 Maximum: 10.
Higher scores mean a worse outcome
|
Baseline
|
Functional capacity
Time Frame: Change from Baseline at 4 weeks
|
Dash Scale.
Minimum: 0 Maximum: 100.
Higher scores mean a worse outcome
|
Change from Baseline at 4 weeks
|
Shoulder joint mobility
Time Frame: Change from Baseline at 4 weeks
|
Goniometer Records
|
Change from Baseline at 4 weeks
|
Degree of pain
Time Frame: Change from Baseline at 4 weeks
|
Visual Analog Scale
|
Change from Baseline at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: Baseline
|
Years
|
Baseline
|
Pathology of access to the study
Time Frame: Baseline
|
Suture of the rotator cuff or fracture of the proximal limb of the humerus
|
Baseline
|
Sex
Time Frame: Baseline
|
Man or woman
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Inés Carmona Barrientos, Dra., University of Cádiz
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- InesCarmona
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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