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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04944446
Other study ID # InesCarmona
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2018
Est. completion date January 15, 2021

Study information

Verified date June 2021
Source University of Cadiz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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),


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 15, 2021
Est. primary completion date September 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Faculty of Nursing and Physiotherapy. University of Cadiz Cádiz

Sponsors (1)

Lead Sponsor Collaborator
University of Cadiz

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. Review. — View 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. — View Citation

Castro-Martín E, Ortiz-Comino L, Gallart-Aragón 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 P — View Citation

Castro-Sánchez AM, Matarán-Peñarrocha 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 fibrom — View Citation

Rodríguez-Fuentes I, De Toro FJ, Rodríguez-Fuentes G, de Oliveira IM, Meijide-Faílde 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 Ju — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Functional capacity Dash Scale. Minimum: 0 Maximum: 100. Higher scores mean a worse outcome Baseline
Primary Shoulder joint mobility Goniometer Records Baseline
Primary Degree of pain Visual Analog Scale. Minimum: 0 Maximum: 10. Higher scores mean a worse outcome Baseline
Primary Functional capacity Dash Scale. Minimum: 0 Maximum: 100. Higher scores mean a worse outcome Change from Baseline at 4 weeks
Primary Shoulder joint mobility Goniometer Records Change from Baseline at 4 weeks
Primary Degree of pain Visual Analog Scale Change from Baseline at 4 weeks
Secondary Pathology of access to the study Suture of the rotator cuff or fracture of the proximal limb of the humerus Baseline
Secondary Age Years Baseline
Secondary Sex Man or woman Baseline
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