Clinical trial NCT04944446: Myofascial Release in Shoulder Pathologies
Official title: Effectiveness of Myofascial Release in Pathologies of the Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Humerus Fracture
Rotator Cuff Injuries
Keywords: Shoulder
Pathology
Myofascial release
Clinical trial
Lead sponsor: University of Cadiz
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled longitudinal experimental study
Primary purpose: TREATMENT

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.

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),

Eligibility criteria: 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.

Primary outcomes:
measure: Functional capacity
timeFrame: Baseline
measure: Shoulder joint mobility
timeFrame: Baseline
measure: Degree of pain
timeFrame: Baseline
measure: Functional capacity
timeFrame: Change from Baseline at 4 weeks
measure: Shoulder joint mobility
timeFrame: Change from Baseline at 4 weeks
measure: Degree of pain
timeFrame: Change from Baseline at 4 weeks
Secondary outcomes:
measure: Pathology of access to the study
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
Other outcomes:
Locations:
city: Cádiz
country: Spain
facility: Faculty of Nursing and Physiotherapy. University of Cadiz
Study officials:
affiliation: University of Cádiz
name: Inés Carmona Barrientos, Dra.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.