Back to resultsMyofascial Release in Shoulder Pathologies
Primary Purpose
Humerus Fracture, Rotator Cuff Injuries
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Humerus Fracture focused on measuring Shoulder, Pathology, Myofascial release, Clinical trial
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.
Sites / Locations
- Faculty of Nursing and Physiotherapy. University of Cadiz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group myofascial treatment
Group Kinesitherapy treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Functional capacity
Dash Scale. Minimum: 0 Maximum: 100. Higher scores mean a worse outcome
Shoulder joint mobility
Goniometer Records
Degree of pain
Visual Analog Scale. Minimum: 0 Maximum: 10. Higher scores mean a worse outcome
Functional capacity
Dash Scale. Minimum: 0 Maximum: 100. Higher scores mean a worse outcome
Shoulder joint mobility
Goniometer Records
Degree of pain
Visual Analog Scale
Secondary Outcome Measures
Pathology of access to the study
Suture of the rotator cuff or fracture of the proximal limb of the humerus
Age
Years
Sex
Man or woman
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04944446
Brief Title
Myofascial Release in Shoulder Pathologies
Official Title
Effectiveness of Myofascial Release in Pathologies of the Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
September 5, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cadiz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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),
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humerus Fracture, Rotator Cuff Injuries
Keywords
Shoulder, Pathology, Myofascial release, Clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled longitudinal experimental study
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant, Outcomes Assessor) external evaluator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group myofascial treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Group Kinesitherapy treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment
Intervention Description
Myofascial release of various muscle groups Treatment of mobilization of the shoulder joint
Primary Outcome Measure Information:
Title
Functional capacity
Description
Dash Scale. Minimum: 0 Maximum: 100. Higher scores mean a worse outcome
Time Frame
Baseline
Title
Shoulder joint mobility
Description
Goniometer Records
Time Frame
Baseline
Title
Degree of pain
Description
Visual Analog Scale. Minimum: 0 Maximum: 10. Higher scores mean a worse outcome
Time Frame
Baseline
Title
Functional capacity
Description
Dash Scale. Minimum: 0 Maximum: 100. Higher scores mean a worse outcome
Time Frame
Change from Baseline at 4 weeks
Title
Shoulder joint mobility
Description
Goniometer Records
Time Frame
Change from Baseline at 4 weeks
Title
Degree of pain
Description
Visual Analog Scale
Time Frame
Change from Baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Pathology of access to the study
Description
Suture of the rotator cuff or fracture of the proximal limb of the humerus
Time Frame
Baseline
Title
Age
Description
Years
Time Frame
Baseline
Title
Sex
Description
Man or woman
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inés Carmona Barrientos, Dra.
Organizational Affiliation
University of Cádiz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Nursing and Physiotherapy. University of Cadiz
City
Cádiz
ZIP/Postal Code
11008
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25603749
Citation
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.
Results Reference
result
PubMed Identifier
28003133
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.
Results Reference
result
PubMed Identifier
26745225
Citation
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.
Results Reference
result
PubMed Identifier
22236639
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.
Results Reference
result
PubMed Identifier
21234327
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.
Results Reference
result
PubMed Identifier
35397306
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.
Results Reference
derived
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Myofascial Release in Shoulder Pathologies
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